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Clinical Trial Results:
Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Summary
EudraCT number	2014-001471-31
Trial protocol	HU CZ DE BG RO
Global end of trial date	23 May 2016

Results information
Results version number	v1(current)
This version publication date	04 Jun 2017
First version publication date	04 Jun 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

M12-965

ISRCTN number

US NCT number

NCT02433340

WHO universal trial number (UTN)

Sponsor organisation name

Abbvie Deutschland GmbH & Co.KG

Sponsor organisation address

AbbVie House, Vanwall Business Park, Vanwall Road , Maidenhead, Berkshire , United Kingdom, SL6-4UB

Public contact

Lawrence McNamee, Clinical Lead, AbbVie, Lawrence.McNamee@abbvie.com

Scientific contact

Paul Peloso, Medical Director, AbbVie, heikki.mansikka@abbvie.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

23 May 2016

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

23 May 2016

Was the trial ended prematurely?

Yes

Main objective of the trial

This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of ABT-122 (60 mg every other week [EOW], 120 mg EOW, or 120 mg every week [EW]) or adalimumab 40 mg EOW given on background methotrexate.

Protection of trial subjects

Participant and/or legal guardian read and understood the information provided about the study and gave written permission.

Background therapy

Evidence for comparator

Actual start date of recruitment

20 Apr 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Czech Republic: 17

Country: Number of subjects enrolled

Bulgaria: 15

Country: Number of subjects enrolled

Germany: 1

Country: Number of subjects enrolled

Hungary: 11

Country: Number of subjects enrolled

New Zealand: 8

Country: Number of subjects enrolled

Poland: 100

Country: Number of subjects enrolled

Romania: 6

Worldwide total number of subjects

158

EEA total number of subjects

150

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

120

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 158 subjects (98% of those eligible) diagnosed with active rheumatoid arthritis (RA) on background methotrexate who had participated in the randomized controlled trial M12-963 (2014-001471-31) enrolled in this open-label extension. Results include analyses of data for these subjects from time points during M12-963, per protocol.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

ADA 40 mg EOW / ABT-122 120 mg EOW

Arm description

Double-blind Adalimumab (ADA) 40 mg every other week (EOW) for 11 weeks. Open-label ABT-122 120 mg EOW.

Arm type

Experimental

Investigational medicinal product name

ABT-122

Investigational medicinal product code

ABT-122

Other name

Remtolumab

Pharmaceutical forms

Powder for injection, Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

ABT-122 was provided as a lyophilized powder for reconstitution prior to injection; however, once the PFS became available, ABT-122 was provided as a solution for injection in a pre-filled syringe. All subjects received ABT-122 120 mg EOW in an open-label fashion with the possibility of an extra 120 mg dose based upon the loss of ACR20 response.

ABT-122 60 mg EOW / 120 mg EOW

Arm description

Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.

Arm type

Experimental

Investigational medicinal product name

ABT-122

Investigational medicinal product code

ABT-122

Other name

Remtolumab

Pharmaceutical forms

Powder for injection, Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

ABT-122 120 mg EOW / 120 mg EOW

Arm description

Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.

Arm type

Experimental

Investigational medicinal product name

ABT-122

Investigational medicinal product code

ABT-122

Other name

Remtolumab

Pharmaceutical forms

Powder for injection, Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

ABT-122 120 mg EW / 120 mg EOW

Arm description

Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.

Arm type

Experimental

Investigational medicinal product name

ABT-122

Investigational medicinal product code

ABT-122

Other name

Remtolumab

Pharmaceutical forms

Powder for injection, Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Number of subjects in period 1	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW
Started	42	37	39	40
Completed	40	35	37	38
Not completed	2	2	2	2
Consent withdrawn by subject	1	-	1	2
Adverse event, non-fatal	-	-	1	-
Not Specified	-	1	-	-
Required Alternative/Prohibited Therapy	1	-	-	-
Lost to follow-up	-	1	-	-

Baseline characteristics

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Reporting group title

ADA 40 mg EOW / ABT-122 120 mg EOW

Reporting group description

Double-blind Adalimumab (ADA) 40 mg every other week (EOW) for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group title

ABT-122 60 mg EOW / 120 mg EOW

Reporting group description

Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group title

ABT-122 120 mg EOW / 120 mg EOW

Reporting group description

Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group title

ABT-122 120 mg EW / 120 mg EOW

Reporting group description

Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	Total
Number of subjects	42	37	39	40	158
Age, Customized
Units: Participants
< 40 years	4	5	7	5	21
40 to < 65 years	27	24	22	26	99
>= 65 years	11	8	10	9	38
Gender categorical
Units: Subjects
Female	30	29	33	32	124
Male	12	8	6	8	34

End points

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Reporting group title

ADA 40 mg EOW / ABT-122 120 mg EOW

Reporting group description

Double-blind Adalimumab (ADA) 40 mg every other week (EOW) for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group title

ABT-122 60 mg EOW / 120 mg EOW

Reporting group description

Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group title

ABT-122 120 mg EOW / 120 mg EOW

Reporting group description

Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group title

ABT-122 120 mg EW / 120 mg EOW

Reporting group description

Double-blind ABT-122 120 mg every week (EW) for 11 weeks. Open-label ABT-122 120 mg EOW.

Subject analysis set title

All ABT-122 120 mg EOW

Subject analysis set type

Full analysis

Subject analysis set description

Open-label ABT-122 120 mg EOW.

Subject analysis set title

All ABT-122 120 mg EOW

Subject analysis set type

Full analysis

Subject analysis set description

Open-label ABT-122 120 mg EOW.

Subject analysis set title

All ABT-122 120 mg EOW

Subject analysis set type

Full analysis

Subject analysis set description

Open-label ABT-122 120 mg EOW.

Subject analysis set title

All ABT-122 120 mg EOW

Subject analysis set type

Full analysis

Subject analysis set description

Open-label ABT-122 120 mg EOW.

Subject analysis set title

All ABT-122 120 mg EOW

Subject analysis set type

Full analysis

Subject analysis set description

Open-label ABT-122 120 mg EOW.

Subject analysis set title

All ABT-122 120 mg EOW

Subject analysis set type

Full analysis

Subject analysis set description

Open-label ABT-122 120 mg EOW.

Subject analysis set title

All ABT-122 120 mg EOW

Subject analysis set type

Full analysis

Subject analysis set description

Open-label ABT-122 120 mg EOW.

Subject analysis set title

All ABT-122 120 mg EOW

Subject analysis set type

Full analysis

Subject analysis set description

Open-label ABT-122 120 mg EOW.

Subject analysis set title

All ABT-122 120 mg EOW

Subject analysis set type

Full analysis

Subject analysis set description

Open-label ABT-122 120 mg EOW.

Subject analysis set title

All ABT-122 120 mg EOW

Subject analysis set type

Full analysis

Subject analysis set description

Open-label ABT-122 120 mg EOW.

Primary: American College of Rheumatology (ACR) 20 Response Rate at Week 2

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End point title

American College of Rheumatology (ACR) 20 Response Rate at Week 2 ^[1]

End point description

Percentage of subjects with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. Last observation carried forward (LOCF) was used for missing data.

End point type

Primary

End point timeframe

Week 2 of Study M12-963

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	37	39	38	154
Units: percentage of participants
number (confidence interval 95%)	45 (30.7 to 60.2)	43.2 (28.7 to 59.1)	46.2 (31.6 to 61.4)	47.4 (32.5 to 62.7)	45.5 (37.8 to 53.3)

No statistical analyses for this end point

Primary: ACR20 Response Rate at Week 4

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End point title

ACR20 Response Rate at Week 4 ^[2]

End point description

Percentage of subjects with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Primary

End point timeframe

Week 4 of Study M12-963

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	39	157
Units: percentage of participants
number (confidence interval 95%)	50 (35.5 to 64.5)	64.9 (48.7 to 78.2)	46.2 (31.6 to 61.4)	74.4 (58.8 to 85.6)	58.6 (50.8 to 66)

No statistical analyses for this end point

Primary: ACR20 Response Rate at Week 6

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End point title

ACR20 Response Rate at Week 6 ^[3]

End point description

End point type

Primary

End point timeframe

Week 6 of Study M12-963

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	39	157
Units: percentage of participants
number (confidence interval 95%)	66.7 (51.5 to 79.1)	70.3 (54.1 to 82.6)	66.7 (50.9 to 79.4)	79.5 (64.2 to 89.5)	70.7 (63.1 to 77.3)

No statistical analyses for this end point

Primary: ACR20 Response Rate at Week 8

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End point title

ACR20 Response Rate at Week 8 ^[4]

End point description

End point type

Primary

End point timeframe

Week 8 of Study M12-963

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	76.2 (61.3 to 86.7)	75.7 (59.7 to 86.8)	69.2 (53.5 to 81.5)	80 (65 to 89.8)	75.3 (68 to 81.4)

No statistical analyses for this end point

Primary: ACR20 Response Rate at Week 12

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End point title

ACR20 Response Rate at Week 12 ^[5]

End point description

End point type

Primary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	78.6 (63.8 to 88.5)	70.3 (54.1 to 82.6)	84.6 (69.9 to 93.1)	82.5 (67.7 to 91.6)	79.1 (72.1 to 84.8)

No statistical analyses for this end point

Primary: ACR20 Response Rate at Week 16

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End point title

ACR20 Response Rate at Week 16 ^[6]

End point description

End point type

Primary

End point timeframe

Week 16 (Week 4 of Study M12-965)

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	36	37	40	154
Units: percentage of participants
number (confidence interval 95%)	85.4 (71.2 to 93.5)	77.8 (61.7 to 88.5)	86.5 (71.5 to 94.6)	77.5 (62.3 to 87.9)	81.8 (74.9 to 87.2)

No statistical analyses for this end point

Primary: ACR20 Response Rate at Week 20

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End point title

ACR20 Response Rate at Week 20 ^[7]

End point description

End point type

Primary

End point timeframe

Week 20 (Week 8 of Study M12-965)

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: percentage of participants
number (confidence interval 95%)	71.4 (56.3 to 82.9)	77.8 (61.7 to 88.5)	82.1 (67 to 91.3)	79.5 (64.2 to 89.5)	77.6 (70.4 to 83.4)

No statistical analyses for this end point

Primary: ACR20 Response Rate at Week 24

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End point title

ACR20 Response Rate at Week 24 ^[8]

End point description

End point type

Primary

End point timeframe

Week 24 (Week 12 of Study M12-965)

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: percentage of participants
number (confidence interval 95%)	78.6 (63.8 to 88.5)	77.8 (61.7 to 88.5)	76.9 (61.5 to 87.6)	84.6 (69.9 to 93.1)	79.5 (72.4 to 85.1)

No statistical analyses for this end point

Primary: ACR20 Response Rate at Week 28

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End point title

ACR20 Response Rate at Week 28 ^[9]

End point description

End point type

Primary

End point timeframe

Week 28 (Week 16 of Study M12-965)

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: percentage of participants
number (confidence interval 95%)	73.8 (58.8 to 84.8)	75 (58.7 to 86.4)	74.4 (58.8 to 85.6)	82.1 (67 to 91.3)	76.3 (69 to 82.3)

No statistical analyses for this end point

Primary: ACR20 Response Rate at Week 32

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End point title

ACR20 Response Rate at Week 32 ^[10]

End point description

End point type

Primary

End point timeframe

Week 32 (Week 20 of Study M12-965)

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	76.2 (61.3 to 86.7)	72.2 (55.9 to 84.3)	79.5 (64.2 to 89.5)	80 (65 to 89.8)	77.1 (69.9 to 83)

No statistical analyses for this end point

Primary: ACR20 Response Rate at Week 36

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End point title

ACR20 Response Rate at Week 36 ^[11]

End point description

End point type

Primary

End point timeframe

Week 36 (Week 24 of Study M12-965)

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	71.4 (56.3 to 82.9)	72.2 (55.9 to 84.3)	84.6 (69.9 to 93.1)	85 (70.5 to 93.3)	78.3 (71.2 to 84.1)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 2

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End point title

ACR50 Response Rate at Week 2 ^[12]

End point description

Percentage of subjects with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Primary

End point timeframe

Week 2 of Study M12-963

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	37	39	39	155
Units: percentage of participants
number (confidence interval 95%)	10 (3.4 to 23.6)	8.1 (2.1 to 22)	20.5 (10.5 to 35.8)	23.1 (12.4 to 38.5)	15.5 (10.6 to 22.1)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 4

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End point title

ACR50 Response Rate at Week 4 ^[13]

End point description

End point type

Primary

End point timeframe

Week 4 of Study M12-963

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	39	157
Units: percentage of participants
number (confidence interval 95%)	14.3 (6.3 to 28.2)	29.7 (17.4 to 45.9)	23.1 (12.4 to 38.5)	35.9 (22.7 to 51.6)	25.5 (19.3 to 32.8)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 6

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End point title

ACR50 Response Rate at Week 6 ^[14]

End point description

End point type

Primary

End point timeframe

Week 6 of Study M12-963

Notes
[14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	33.3 (20.9 to 48.5)	35.1 (21.8 to 51.3)	38.5 (24.9 to 54.1)	42.5 (28.5 to 57.8)	37.3 (30.2 to 45.1)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 8

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End point title

ACR50 Response Rate at Week 8 ^[15]

End point description

End point type

Primary

End point timeframe

Week 8 of Study M12-963

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	45.2 (31.2 to 60.1)	29.7 (17.4 to 45.9)	41 (27.1 to 56.6)	42.5 (28.5 to 57.8)	39.9 (32.6 to 47.7)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 12

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End point title

ACR50 Response Rate at Week 12 ^[16]

End point description

End point type

Primary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	39	157
Units: percentage of participants
number (confidence interval 95%)	52.4 (37.7 to 66.6)	37.8 (24 to 53.9)	51.3 (36.2 to 66.1)	46.2 (31.6 to 61.4)	47.1 (39.5 to 54.9)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 16

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End point title

ACR50 Response Rate at Week 16 ^[17]

End point description

End point type

Primary

End point timeframe

Week 16 (Week 4 of Study M12-965)

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	35	37	39	152
Units: percentage of participants
number (confidence interval 95%)	36.6 (23.5 to 51.9)	51.4 (35.6 to 67)	56.8 (40.9 to 71.3)	56.4 (41 to 70.7)	50 (42.1 to 57.9)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 20

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End point title

ACR50 Response Rate at Week 20 ^[18]

End point description

End point type

Primary

End point timeframe

Week 20 (Week 8 of Study M12-965)

Notes
[18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	42.9 (29.1 to 57.8)	52.8 (37 to 68)	51.3 (36.2 to 66.1)	52.5 (37.5 to 67.1)	49.7 (42 to 57.4)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 24

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End point title

ACR50 Response Rate at Week 24 ^[19]

End point description

End point type

Primary

End point timeframe

Week 24 (Week 12 of Study M12-965)

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: percentage of participants
number (confidence interval 95%)	40.5 (27 to 55.5)	47.2 (32 to 63)	53.8 (38.6 to 68.4)	71.8 (56.1 to 83.6)	53.2 (45.4 to 60.9)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 28

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End point title

ACR50 Response Rate at Week 28 ^[20]

End point description

End point type

Primary

End point timeframe

Week 28 (Week 16 of Study M12-965)

Notes
[20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: percentage of participants
number (confidence interval 95%)	50 (35.5 to 64.5)	47.2 (32 to 63)	51.3 (36.2 to 66.1)	69.2 (53.5 to 81.5)	54.5 (46.7 to 62.1)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 32

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End point title

ACR50 Response Rate at Week 32 ^[21]

End point description

End point type

Primary

End point timeframe

Week 32 (Week 20 of Study M12-965)

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	45.2 (31.2 to 60.1)	58.3 (42.2 to 72.9)	51.3 (36.2 to 66.1)	62.5 (47 to 75.8)	54.1 (46.3 to 61.7)

No statistical analyses for this end point

Primary: ACR50 Response Rate at Week 36

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End point title

ACR50 Response Rate at Week 36 ^[22]

End point description

End point type

Primary

End point timeframe

Week 36 (Week 24 of Study M12-965)

Notes
[22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	45.2 (31.2 to 60.1)	50 (34.5 to 65.5)	53.8 (38.6 to 68.4)	62.5 (47 to 75.8)	52.9 (45.1 to 60.5)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 2

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End point title

ACR70 Response Rate at Week 2 ^[23]

End point description

Percentage of subjects with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Primary

End point timeframe

Week 2 of Study M12-963

Notes
[23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	37	39	39	155
Units: percentage of participants
number (confidence interval 95%)	0 (0 to 10.4)	2.7 (0 to 15.1)	5.1 (0.5 to 17.8)	5.1 (0.5 to 17.8)	3.2 (1.2 to 7.5)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 4

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End point title

ACR70 Response Rate at Week 4 ^[24]

End point description

End point type

Primary

End point timeframe

Week 4 of Study M12-963

Notes
[24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	4.8 (0.5 to 16.6)	10.8 (3.7 to 25.3)	10.3 (3.5 to 24.2)	17.5 (8.4 to 32.3)	10.8 (6.7 to 16.6)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 6

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End point title

ACR70 Response Rate at Week 6 ^[25]

End point description

End point type

Primary

End point timeframe

Week 6 of Study M12-963

Notes
[25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	16.7 (8 to 30.9)	13.5 (5.4 to 28.5)	17.9 (8.7 to 33)	20 (10.2 to 35)	17.1 (12 to 23.8)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 8

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End point title

ACR70 Response Rate at Week 8 ^[26]

End point description

End point type

Primary

End point timeframe

Week 8 of Study M12-963

Notes
[26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	19 (9.7 to 33.6)	8.1 (2.1 to 22)	25.6 (14.4 to 41.2)	27.5 (16 to 43)	20.3 (14.7 to 27.2)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 12

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End point title

ACR70 Response Rate at Week 12 ^[27]

End point description

End point type

Primary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

Notes
[27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	23.8 (13.3 to 38.7)	24.3 (13.2 to 40.3)	20.5 (10.5 to 35.8)	35 (22.1 to 50.5)	25.9 (19.7 to 33.3)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 16

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End point title

ACR70 Response Rate at Week 16 ^[28]

End point description

End point type

Primary

End point timeframe

Week 16 (Week 4 of Study M12-965)

Notes
[28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	36	36	39	151
Units: percentage of participants
number (confidence interval 95%)	15 (6.7 to 29.5)	30.6 (17.9 to 47)	33.3 (20.1 to 49.7)	25.6 (14.4 to 41.2)	25.8 (19.5 to 33.4)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 20

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End point title

ACR70 Response Rate at Week 20 ^[29]

End point description

End point type

Primary

End point timeframe

Week 20 (Week 8 of Study M12-965)

Notes
[29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	35	39	40	156
Units: percentage of participants
number (confidence interval 95%)	19 (9.7 to 33.6)	31.4 (18.4 to 48.1)	33.3 (20.6 to 49.1)	32.5 (20 to 48.1)	28.8 (22.3 to 36.4)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 24

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End point title

ACR70 Response Rate at Week 24 ^[30]

End point description

End point type

Primary

End point timeframe

Week 24 (Week 12 of Study M12-965)

Notes
[30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	19 (9.7 to 33.6)	25 (13.6 to 41.3)	28.2 (16.4 to 43.9)	40 (26.3 to 55.4)	28 (21.6 to 35.5)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 28

Top of page

End point title

ACR70 Response Rate at Week 28 ^[31]

End point description

End point type

Primary

End point timeframe

Week 28 (Week 16 of Study M12-965)

Notes
[31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: percentage of participants
number (confidence interval 95%)	16.7 (8 to 30.9)	27.8 (15.7 to 44.1)	30.8 (18.5 to 46.5)	41 (27.1 to 56.6)	28.8 (22.3 to 36.4)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 32

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End point title

ACR70 Response Rate at Week 32 ^[32]

End point description

End point type

Primary

End point timeframe

Week 32 (Week 20 of Study M12-965)

Notes
[32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	16.7 (8 to 30.9)	27.8 (15.7 to 44.1)	23.1 (12.4 to 38.5)	42.5 (28.5 to 57.8)	27.4 (21 to 34.9)

No statistical analyses for this end point

Primary: ACR70 Response Rate at Week 36

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End point title

ACR70 Response Rate at Week 36 ^[33]

End point description

End point type

Primary

End point timeframe

Week 36 (Week 24 of Study M12-965)

Notes
[33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	23.8 (13.3 to 38.7)	30.6 (17.9 to 47)	35.9 (22.7 to 51.6)	45 (30.7 to 60.2)	33.8 (26.8 to 41.5)

No statistical analyses for this end point

Primary: Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths

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End point title

Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths ^[34]

End point description

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

End point type

Primary

End point timeframe

from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks)

Notes
[34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive statistics are presented, per protocol.

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: Participants
number (not applicable)
Any AE	17	15	19	14	65
AE possibly study drug-related	5	6	6	6	23
SAE possibly study drug-related	0	0	0	0	0
Severe AE	0	1	1	0	2
SAE	0	1	5	0	6
AE leading to study drug discontinuation	1	0	1	0	2
AE leading to Death	0	0	0	0	0
Death (includes non-treatment-emergent)	0	0	0	0	0

No statistical analyses for this end point

Secondary: Change From Baseline In Tender Joint Count (TJC68) at Week 2

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End point title

Change From Baseline In Tender Joint Count (TJC68) at Week 2

End point description

At each study visit, a joint evaluator assessed whether a particular joint was "tender or painful" where presence of tenderness was scored as "1" and the absence of tenderness was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	36	39	40	155
Units: units on a scale
arithmetic mean (standard deviation)	-9.4 ± 10.28	-11.6 ± 10.57	-11 ± 11.12	-12.9 ± 13.84	-11.2 ± 11.52

No statistical analyses for this end point

Secondary: Change From Baseline in TJC68 at Week 4

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End point title

Change From Baseline in TJC68 at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-13.1 ± 9.98	-16.6 ± 12.48	-13.6 ± 12	-16.1 ± 12.77	-14.8 ± 11.8

No statistical analyses for this end point

Secondary: Change From Baseline in TJC68 at Week 6

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End point title

Change From Baseline in TJC68 at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-15.8 ± 10.18	-16.9 ± 11.67	-15.3 ± 11.05	-16.6 ± 12.56	-16.1 ± 11.28

No statistical analyses for this end point

Secondary: Change From Baseline in TJC68 at Week 8

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End point title

Change From Baseline in TJC68 at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-17.3 ± 9.93	-17.4 ± 10.85	-17.1 ± 10.21	-17.1 ± 13.33	-17.2 ± 11.05

No statistical analyses for this end point

Secondary: Change From Baseline in TJC68 at Week 12

Top of page

End point title

Change From Baseline in TJC68 at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-18.4 ± 11.78	-16.9 ± 10.9	-18.6 ± 10.16	-18 ± 12.64	-18 ± 11.34

No statistical analyses for this end point

Secondary: Change From Baseline in TJC68 at Week 16

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End point title

Change From Baseline in TJC68 at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	36	37	40	154
Units: units on a scale
arithmetic mean (standard deviation)	-18.3 ± 12.03	-19.2 ± 10.57	-17.6 ± 9.14	-18.1 ± 12.38	-18.3 ± 11.07

No statistical analyses for this end point

Secondary: Change From Baseline in TJC68 at Week 20

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End point title

Change From Baseline in TJC68 at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-17.6 ± 11.93	-19.7 ± 10.6	-17.8 ± 10.31	-19 ± 11.89	-18.5 ± 11.16

No statistical analyses for this end point

Secondary: Change From Baseline in TJC68 at Week 24

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End point title

Change From Baseline in TJC68 at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-19.3 ± 12.16	-18.3 ± 10.27	-17.4 ± 9.7	-19.8 ± 12.32	-18.7 ± 11.15

No statistical analyses for this end point

Secondary: Change From Baseline in TJC68 at Week 28

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End point title

Change From Baseline in TJC68 at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-18.2 ± 10.88	-18.9 ± 12.26	-17.9 ± 10.31	-21 ± 13.02	-19 ± 11.6

No statistical analyses for this end point

Secondary: Change From Baseline in TJC68 at Week 32

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End point title

Change From Baseline in TJC68 at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-18.2 ± 11.72	-19.7 ± 11.04	-17.9 ± 10.47	-20.3 ± 13.38	-19 ± 11.66

No statistical analyses for this end point

Secondary: Change From Baseline in TJC68 at Week 36

Top of page

End point title

Change From Baseline in TJC68 at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-18.2 ± 10.92	-18.5 ± 11.92	-17.7 ± 10.06	-20.3 ± 12.88	-18.7 ± 11.42

No statistical analyses for this end point

Secondary: Change From Baseline in Swollen Joint Count (SJC66) at Week 2

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End point title

Change From Baseline in Swollen Joint Count (SJC66) at Week 2

End point description

At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	36	39	40	155
Units: units on a scale
arithmetic mean (standard deviation)	-8 ± 9.07	-8.8 ± 8.5	-8.6 ± 10.84	-10.8 ± 9.34	-9 ± 9.46

No statistical analyses for this end point

Secondary: Change From Baseline in SJC66 at Week 4

Top of page

End point title

Change From Baseline in SJC66 at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-8.8 ± 8.72	-10.6 ± 8.04	-10.3 ± 10.5	-13.3 ± 9.29	-10.7 ± 9.26

No statistical analyses for this end point

Secondary: Change From Baseline in SJC66 at Week 6

Top of page

End point title

Change From Baseline in SJC66 at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-11.8 ± 8.09	-11.9 ± 7.71	-12.3 ± 10.15	-13.3 ± 9.31	-12.3 ± 8.81

No statistical analyses for this end point

Secondary: Change From Baseline in SJC66 at Week 8

Top of page

End point title

Change From Baseline in SJC66 at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-12.2 ± 8.26	-12.4 ± 7.76	-13.8 ± 9.32	-14.3 ± 9.43	-13.2 ± 8.7

No statistical analyses for this end point

Secondary: Change From Baseline in SJC66 at Week 12

Top of page

End point title

Change From Baseline in SJC66 at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-12.6 ± 8.73	-11.8 ± 9.51	-13.4 ± 9.13	-14.8 ± 9	-13.2 ± 9.06

No statistical analyses for this end point

Secondary: Change From Baseline in SJC66 at Week 16

Top of page

End point title

Change From Baseline in SJC66 at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	36	37	40	154
Units: units on a scale
arithmetic mean (standard deviation)	-13 ± 8.5	-13.5 ± 9.6	-13.8 ± 8.9	-14.5 ± 8.69	-13.7 ± 8.84

No statistical analyses for this end point

Secondary: Change From Baseline in SJC66 at Week 20

Top of page

End point title

Change From Baseline in SJC66 at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-12.2 ± 7.47	-14.6 ± 8.97	-13.8 ± 10.3	-15.4 ± 8.95	-14 ± 8.95

No statistical analyses for this end point

Secondary: Change From Baseline in SJC66 at Week 24

Top of page

End point title

Change From Baseline in SJC66 at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-14 ± 8.21	-13.8 ± 8.68	-14.6 ± 9.87	-15.6 ± 9.16	-14.5 ± 8.93

No statistical analyses for this end point

Secondary: Change From Baseline in SJC66 at Week 28

Top of page

End point title

Change From Baseline in SJC66 at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-13.3 ± 6.88	-14 ± 10.12	-14.9 ± 9.49	-15.8 ± 9.29	-14.5 ± 8.94

No statistical analyses for this end point

Secondary: Change From Baseline in SJC66 at Week 32

Top of page

End point title

Change From Baseline in SJC66 at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-13.1 ± 8.14	-13.9 ± 10.34	-14.3 ± 9.81	-14.9 ± 9.71	-14.1 ± 9.43

No statistical analyses for this end point

Secondary: Change From Baseline in SJC66 at Week 36

Top of page

End point title

Change From Baseline in SJC66 at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-12.4 ± 7.76	-14 ± 10.55	-15 ± 9.57	-14.8 ± 9.82	-14 ± 9.4

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 2

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 2

End point description

Subjects assessed their pain in the previous week using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	36	39	39	154
Units: units on a scale
arithmetic mean (standard deviation)	-17.9 ± 22.82	-20.1 ± 16.83	-22.4 ± 23.49	-22.3 ± 22.46	-20.7 ± 21.53

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 4

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-24.5 ± 20.24	-28.7 ± 20.76	-24.8 ± 26.57	-29.3 ± 23.07	-26.8 ± 22.68

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 6

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-31.8 ± 21.24	-29.1 ± 22.48	-29.8 ± 27.07	-29.9 ± 21.36	-30.2 ± 22.92

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 8

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-30.5 ± 24.64	-29.8 ± 21.56	-30.2 ± 27.89	-36 ± 23.11	-31.7 ± 24.36

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 12

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-36.2 ± 19.91	-29.3 ± 22.34	-37.9 ± 27.18	-36.5 ± 23.52	-35.1 ± 23.34

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 16

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	36	37	40	154
Units: units on a scale
arithmetic mean (standard deviation)	-31.9 ± 24.68	-33 ± 24.11	-35 ± 28.43	-38.5 ± 22.92	-34.6 ± 24.96

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 20

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-30.2 ± 22.48	-40.3 ± 24.12	-37.8 ± 28.78	-36.8 ± 21.72	-36.1 ± 24.44

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 24

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-31.7 ± 21.86	-35.9 ± 23.28	-32 ± 30.31	-39.4 ± 23.64	-34.7 ± 24.92

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 28

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-28.5 ± 22.39	-36.2 ± 28.88	-35.3 ± 28.64	-40.1 ± 22.61	-34.9 ± 25.79

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 32

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-27.3 ± 22.16	-37.4 ± 25.63	-34.3 ± 32.99	-42.8 ± 25.31	-35.3 ± 27.1

No statistical analyses for this end point

Secondary: Change From Baseline in Patient's Assessment of Pain at Week 36

Top of page

End point title

Change From Baseline in Patient's Assessment of Pain at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-31.3 ± 23.36	-36.1 ± 28.9	-39.3 ± 31.37	-41.8 ± 28.21	-37 ± 28.03

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 2

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 2

End point description

Subjects assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	36	39	39	154
Units: units on a scale
arithmetic mean (standard deviation)	-18.1 ± 23.77	-14.2 ± 16.41	-21.3 ± 19.92	-17.2 ± 23.06	-17.7 ± 21.03

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 4

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-20.6 ± 21.73	-25.6 ± 22.33	-20.7 ± 24.62	-26.6 ± 21.79	-23.3 ± 22.58

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 6

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-26.5 ± 20.97	-23.2 ± 22.21	-26.9 ± 24.17	-27.9 ± 21.14	-26.2 ± 21.98

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 8

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-27.1 ± 24.33	-26.8 ± 23.25	-31.8 ± 25.54	-34.1 ± 22.93	-30 ± 24.02

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 12

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-29.2 ± 23.39	-29 ± 25.11	-34.1 ± 21.41	-35.6 ± 25.62	-32 ± 23.86

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 16

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	36	37	40	154
Units: units on a scale
arithmetic mean (standard deviation)	-26.8 ± 24.09	-29.3 ± 24.91	-34.8 ± 20.59	-35.8 ± 22.51	-31.6 ± 23.18

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 20

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-28.5 ± 20.98	-35.6 ± 24.56	-35.4 ± 26.44	-35.4 ± 22.95	-33.6 ± 23.72

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 24

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-31.5 ± 22.81	-33.1 ± 24.25	-32.7 ± 25.16	-38.9 ± 23.63	-34 ± 23.89

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 28

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-25 ± 23.25	-33.1 ± 27.93	-32.6 ± 27.33	-39.7 ± 25.57	-32.5 ± 26.29

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 32

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-27.4 ± 23.87	-34.2 ± 26.17	-32.8 ± 28.91	-43.8 ± 23.56	-34.5 ± 26.12

No statistical analyses for this end point

Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity at Week 36

Top of page

End point title

Change from Baseline in Patient's Global Assessment of Disease Activity at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-29.5 ± 26.04	-32.5 ± 26.16	-37.5 ± 25.73	-38.3 ± 29.65	-34.4 ± 26.96

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2

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End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2

End point description

The physician assessed the subject's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	39	36	39	39	153
Units: units on a scale
arithmetic mean (standard deviation)	-24.5 ± 21.8	-25.8 ± 17.29	-29.5 ± 21.25	-26.5 ± 21.54	-26.6 ± 20.49

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4

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End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-28.6 ± 20.49	-35.5 ± 21.15	-34.5 ± 21.58	-37.3 ± 23	-33.8 ± 21.61

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6

Top of page

End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-38.5 ± 18.77	-39 ± 22.76	-40.3 ± 23.63	-40.1 ± 20.94	-39.5 ± 21.33

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8

Top of page

End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-41 ± 17.82	-39.6 ± 20.94	-45.6 ± 21.16	-43.4 ± 22.87	-42.4 ± 20.65

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12

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End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-44.4 ± 20.3	-42.9 ± 20.9	-49.7 ± 20.54	-47.6 ± 19.86	-46.2 ± 20.36

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16

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End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	35	36	37	148
Units: units on a scale
arithmetic mean (standard deviation)	-46 ± 17.04	-45.3 ± 24.23	-47.3 ± 20.99	-47.3 ± 21.46	-46.4 ± 20.77

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20

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End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	35	38	38	153
Units: units on a scale
arithmetic mean (standard deviation)	-44.3 ± 19.08	-46.1 ± 20.28	-45.6 ± 22.89	-49.3 ± 21.64	-46.3 ± 20.86

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24

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End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-45.8 ± 18.06	-46.7 ± 22	-47.4 ± 23.02	-49.9 ± 23.05	-47.4 ± 21.4

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28

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End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-44.5 ± 20.72	-48.7 ± 22.19	-48.2 ± 22.85	-51.7 ± 20.85	-48.2 ± 21.59

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32

Top of page

End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-45.2 ± 23.07	-50 ± 24.46	-49.9 ± 24.42	-51.7 ± 25.03	-49.1 ± 24.12

No statistical analyses for this end point

Secondary: Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36

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End point title

Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-42.4 ± 23.72	-48 ± 23.1	-50.5 ± 24.55	-51.8 ± 24.24	-48.1 ± 23.98

No statistical analyses for this end point

Secondary: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2

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End point title

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2

End point description

HAQ-DI is a self-reported subject outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 – 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the subject. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ –0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	36	39	39	154
Units: units on a scale
arithmetic mean (standard deviation)	-0.25 ± 0.486	-0.31 ± 0.463	-0.29 ± 0.481	-0.4 ± 0.538	-0.31 ± 0.492

No statistical analyses for this end point

Secondary: Change From Baseline in HAQ-DI at Week 4

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End point title

Change From Baseline in HAQ-DI at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-0.37 ± 0.552	-0.4 ± 0.58	-0.47 ± 0.625	-0.62 ± 0.711	-0.47 ± 0.622

No statistical analyses for this end point

Secondary: Change From Baseline in HAQ-DI at Week 6

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End point title

Change From Baseline in HAQ-DI at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-0.53 ± 0.601	-0.46 ± 0.607	-0.63 ± 0.711	-0.64 ± 0.584	-0.57 ± 0.626

No statistical analyses for this end point

Secondary: Change From Baseline in HAQ-DI at Week 8

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End point title

Change From Baseline in HAQ-DI at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-0.56 ± 0.619	-0.52 ± 0.525	-0.65 ± 0.648	-0.71 ± 0.711	-0.61 ± 0.63

No statistical analyses for this end point

Secondary: Change From Baseline in HAQ-DI at Week 12

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End point title

Change From Baseline in HAQ-DI at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-0.69 ± 0.654	-0.55 ± 0.611	-0.66 ± 0.701	-0.88 ± 0.677	-0.7 ± 0.667

No statistical analyses for this end point

Secondary: Change From Baseline in HAQ-DI at Week 16

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End point title

Change From Baseline in HAQ-DI at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	36	37	40	154
Units: units on a scale
arithmetic mean (standard deviation)	-0.59 ± 0.616	-0.67 ± 0.631	-0.67 ± 0.689	-0.9 ± 0.649	-0.71 ± 0.651

No statistical analyses for this end point

Secondary: Change From Baseline in HAQ-DI at Week 20

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End point title

Change From Baseline in HAQ-DI at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-0.54 ± 0.662	-0.73 ± 0.555	-0.7 ± 0.788	-0.88 ± 0.69	-0.71 ± 0.685

No statistical analyses for this end point

Secondary: Change From Baseline in HAQ-DI at Week 24

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End point title

Change From Baseline in HAQ-DI at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-0.63 ± 0.604	-0.74 ± 0.617	-0.6 ± 0.805	-0.91 ± 0.704	-0.72 ± 0.691

No statistical analyses for this end point

Secondary: Change From Baseline in HAQ-DI at Week 28

Top of page

End point title

Change From Baseline in HAQ-DI at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-0.6 ± 0.6	-0.77 ± 0.63	-0.69 ± 0.727	-0.99 ± 0.699	-0.76 ± 0.676

No statistical analyses for this end point

Secondary: Change From Baseline in HAQ-DI at Week 32

Top of page

End point title

Change From Baseline in HAQ-DI at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-0.54 ± 0.576	-0.76 ± 0.674	-0.66 ± 0.794	-0.91 ± 0.659	-0.71 ± 0.686

No statistical analyses for this end point

Secondary: Change From Baseline in HAQ-DI at Week 36

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End point title

Change From Baseline in HAQ-DI at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-0.62 ± 0.619	-0.73 ± 0.698	-0.71 ± 0.674	-0.81 ± 0.749	-0.72 ± 0.683

No statistical analyses for this end point

Secondary: Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2

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End point title

Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2

End point description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	36	39	40	155
Units: mg/L
arithmetic mean (standard deviation)	-12.6 ± 25.19	-9.9 ± 12.89	-12.6 ± 18.56	-14.9 ± 25.7	-12.5 ± 21.3

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP at Week 4

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End point title

Change From Baseline in hsCRP at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: mg/L
arithmetic mean (standard deviation)	-13.3 ± 25.4	-8 ± 12.37	-11.7 ± 17.43	-14.6 ± 26.51	-12 ± 21.43

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP at Week 6

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End point title

Change From Baseline in hsCRP at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: mg/L
arithmetic mean (standard deviation)	-13.3 ± 25.15	-8 ± 11.98	-10.7 ± 18.84	-14.9 ± 26.56	-11.8 ± 21.63

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP at Week 8

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End point title

Change From Baseline in hsCRP at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: mg/L
arithmetic mean (standard deviation)	-12.2 ± 24.96	-8 ± 13.13	-10.7 ± 19	-12.9 ± 28.42	-11 ± 22.26

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP at Week 12

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End point title

Change From Baseline in hsCRP at Week 12

End point description

For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963. Safety Analysis Set: all subjects who received ≥ 1 dose of study medication in M12-965 and had a baseline and post-baseline assessment. LOCF used for missing data; LOCF imputation was conducted separately for M12-963 and M12-965 (ie, data from M12-963 was not carried forward to visits in M12-965).

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: mg/L
arithmetic mean (standard deviation)	-12.3 ± 25.56	-6.5 ± 14.05	-10.8 ± 17.27	-14.6 ± 25.22	-11.2 ± 21.36

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP at Week 16

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End point title

Change From Baseline in hsCRP at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	36	37	39	153
Units: mg/L
arithmetic mean (standard deviation)	-13.5 ± 24.92	-5.5 ± 17.44	-10.8 ± 16.26	-12.5 ± 24.65	-10.7 ± 21.39

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP at Week 20

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End point title

Change From Baseline in hsCRP at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: mg/L
arithmetic mean (standard deviation)	-11.6 ± 24.46	-6.4 ± 14.07	-10.3 ± 18.66	-11.6 ± 25.06	-10.1 ± 21.16

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP at Week 24

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End point title

Change From Baseline in hsCRP at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: mg/L
arithmetic mean (standard deviation)	-11.3 ± 23.41	-6.7 ± 13.93	-9.1 ± 17.96	-10.8 ± 27.79	-9.6 ± 21.5

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP at Week 28

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End point title

Change From Baseline in hsCRP at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: mg/L
arithmetic mean (standard deviation)	-3.5 ± 48.65	-6.3 ± 17.24	-11.3 ± 18.37	-6.8 ± 26.24	-6.9 ± 30.84

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP at Week 32

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End point title

Change From Baseline in hsCRP at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: mg/L
arithmetic mean (standard deviation)	-9.8 ± 26.15	-7.6 ± 14.59	-8 ± 20.16	-10.4 ± 26.24	-9 ± 22.36

No statistical analyses for this end point

Secondary: Change From Baseline in hsCRP at Week 36

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End point title

Change From Baseline in hsCRP at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: mg/L
arithmetic mean (standard deviation)	-8.7 ± 26.17	-6 ± 16.47	-8.7 ± 17.56	-9 ± 28.55	-8.1 ± 22.83

No statistical analyses for this end point

Secondary: Change from Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2

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End point title

Change from Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2

End point description

The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	37	39	39	155
Units: units on a scale
arithmetic mean (standard deviation)	-1.5 ± 1.23	-1.5 ± 1.06	-1.8 ± 1.27	-1.7 ± 1.13	-1.6 ± 1.17

No statistical analyses for this end point

Secondary: Change from Baseline in DAS28 (hsCRP) at Week 4

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End point title

Change from Baseline in DAS28 (hsCRP) at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: units on a scale
arithmetic mean (standard deviation)	-1.9 ± 1.2	-2.1 ± 1.37	-2.1 ± 1.26	-2.3 ± 1.2	-2.1 ± 1.25

No statistical analyses for this end point

Secondary: Change from Baseline in DAS28 (hsCRP) at Week 6

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End point title

Change from Baseline in DAS28 (hsCRP) at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: units on a scale
arithmetic mean (standard deviation)	-2.4 ± 1.37	-2.2 ± 1.34	-2.5 ± 1.27	-2.4 ± 1.21	-2.4 ± 1.29

No statistical analyses for this end point

Secondary: Change from Baseline in DAS28 (hsCRP) at Week 8

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End point title

Change from Baseline in DAS28 (hsCRP) at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: units on a scale
arithmetic mean (standard deviation)	-2.4 ± 1.29	-2.3 ± 1.25	-2.7 ± 1.3	-2.6 ± 1.32	-2.5 ± 1.28

No statistical analyses for this end point

Secondary: Change from Baseline in DAS28 (hsCRP) at Week 12

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End point title

Change from Baseline in DAS28 (hsCRP) at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: units on a scale
arithmetic mean (standard deviation)	-2.6 ± 1.32	-2.3 ± 1.49	-2.8 ± 1.17	-2.7 ± 1.14	-2.6 ± 1.28

No statistical analyses for this end point

Secondary: Change from Baseline in DAS28 (hsCRP) at Week 16

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End point title

Change from Baseline in DAS28 (hsCRP) at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	36	37	39	153
Units: units on a scale
arithmetic mean (standard deviation)	-2.7 ± 1.21	-2.6 ± 1.54	-2.8 ± 1.19	-2.6 ± 0.92	-2.7 ± 1.22

No statistical analyses for this end point

Secondary: Change from Baseline in DAS28 (hsCRP) at Week 20

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End point title

Change from Baseline in DAS28 (hsCRP) at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-2.7 ± 1.31	-2.8 ± 1.37	-2.7 ± 1.25	-2.8 ± 1.08	-2.7 ± 1.24

No statistical analyses for this end point

Secondary: Change from Baseline in DAS28 (hsCRP) at Week 24

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End point title

Change from Baseline in DAS28 (hsCRP) at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-2.8 ± 1.26	-2.6 ± 1.47	-2.7 ± 1.41	-2.9 ± 1.14	-2.8 ± 1.31

No statistical analyses for this end point

Secondary: Change from Baseline in DAS28 (hsCRP) at Week 28

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End point title

Change from Baseline in DAS28 (hsCRP) at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-2.5 ± 1.45	-2.7 ± 1.46	-2.9 ± 1.24	-2.9 ± 1.06	-2.7 ± 1.31

No statistical analyses for this end point

Secondary: Change from Baseline in DAS28 (hsCRP) at Week 32

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End point title

Change from Baseline in DAS28 (hsCRP) at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-2.6 ± 1.44	-2.8 ± 1.45	-2.7 ± 1.17	-2.9 ± 1.25	-2.8 ± 1.32

No statistical analyses for this end point

Secondary: Change from Baseline in DAS28 (hsCRP) at Week 36

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End point title

Change from Baseline in DAS28 (hsCRP) at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: units on a scale
arithmetic mean (standard deviation)	-2.6 ± 1.45	-2.6 ± 1.48	-2.8 ± 1.22	-2.8 ± 1.32	-2.7 ± 1.36

No statistical analyses for this end point

Secondary: Change from Baseline in Clinical Disease Activity Index (CDAI) at Week 2

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End point title

Change from Baseline in Clinical Disease Activity Index (CDAI) at Week 2

End point description

CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	39	37	39	38	153
Units: units on a scale
arithmetic mean (standard deviation)	-15.9 ± 15.74	-17.4 ± 13.45	-17.5 ± 14.61	-18.2 ± 14.96	-17.3 ± 14.6

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI at Week 4

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End point title

Change from Baseline in CDAI at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	39	157
Units: units on a scale
arithmetic mean (standard deviation)	-20.3 ± 14.27	-24.6 ± 15.61	-22.1 ± 13.95	-24.3 ± 14.03	-22.7 ± 14.43

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI at Week 6

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End point title

Change from Baseline in CDAI at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	39	157
Units: units on a scale
arithmetic mean (standard deviation)	-25.7 ± 14.64	-25.6 ± 14.71	-25.8 ± 13.1	-25.6 ± 13.83	-25.7 ± 13.95

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI at Week 8

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End point title

Change from Baseline in CDAI at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	39	157
Units: units on a scale
arithmetic mean (standard deviation)	-26.7 ± 13.68	-27 ± 13.69	-28.2 ± 12.66	-27.4 ± 13.92	-27.3 ± 13.38

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI at Week 12

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End point title

Change from Baseline in CDAI at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	39	157
Units: units on a scale
arithmetic mean (standard deviation)	-28.4 ± 14.33	-27.2 ± 16.72	-29.7 ± 12.1	-28.8 ± 11.88	-28.5 ± 13.76

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI at Week 16

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End point title

Change from Baseline in CDAI at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	35	36	37	148
Units: units on a scale
arithmetic mean (standard deviation)	-28.1 ± 13.07	-29.9 ± 16.04	-28.5 ± 12.11	-29.6 ± 10.03	-29 ± 12.84

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI at Week 20

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End point title

Change from Baseline in CDAI at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	35	38	38	153
Units: units on a scale
arithmetic mean (standard deviation)	-28.1 ± 13.05	-31.8 ± 14.47	-28.2 ± 13.93	-31.1 ± 11.44	-29.7 ± 13.22

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI at Week 24

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End point title

Change from Baseline in CDAI at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-30.7 ± 13.81	-30.1 ± 15.05	-28.8 ± 14.09	-31 ± 13.15	-30.1 ± 13.91

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI at Week 28

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End point title

Change from Baseline in CDAI at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-28.1 ± 13.27	-31.4 ± 15.09	-29.8 ± 12.77	-32.7 ± 12.79	-30.4 ± 13.46

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI at Week 32

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End point title

Change from Baseline in CDAI at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-28.5 ± 15.08	-32.4 ± 14.63	-29.1 ± 13.4	-31.6 ± 15.08	-30.3 ± 14.52

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI at Week 36

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End point title

Change from Baseline in CDAI at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	39	156
Units: units on a scale
arithmetic mean (standard deviation)	-27.6 ± 14.87	-30.9 ± 15.22	-30 ± 12.28	-30.9 ± 14.34	-29.8 ± 14.15

No statistical analyses for this end point

Secondary: Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate per DAS28 (hsCRP) at Week 2

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End point title

Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate per DAS28 (hsCRP) at Week 2

End point description

Percentage of subjects achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	37	39	39	155
Units: percentage of participants
number (confidence interval 95%)	12.5 (5 to 26.6)	8.1 (2.1 to 22)	28.2 (16.4 to 43.9)	25.6 (14.4 to 41.2)	18.7 (13.3 to 25.6)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per DAS28 (hsCRP) at Week 4

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End point title

LDA or CR Response Rate per DAS28 (hsCRP) at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	31 (19 to 46.1)	32.4 (19.5 to 48.6)	30.8 (18.5 to 46.5)	45 (30.7 to 60.2)	34.8 (27.8 to 42.5)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per DAS28 (hsCRP) at Week 6

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End point title

LDA or CR Response Rate per DAS28 (hsCRP) at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	45.2 (31.2 to 60.1)	24.3 (13.2 to 40.3)	43.6 (29.3 to 59)	50 (35.2 to 64.8)	41.1 (33.8 to 48.9)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per DAS28 (hsCRP) at Week 8

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End point title

LDA or CR Response Rate per DAS28 (hsCRP) at Week 8

End point description

Percentage of subjects achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method. Safety Analysis Set: all subjects who received ≥ 1 dose of study medication in M12-965 and had a baseline and post-baseline assessment. LOCF used for missing data; LOCF imputation was conducted separately for M12-963 and M12-965 (ie, data from M12-963 was not carried forward to visits in M12-965).

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	45.2 (31.2 to 60.1)	27 (15.2 to 43.1)	53.8 (38.6 to 68.4)	55 (39.8 to 69.3)	45.6 (38 to 53.3)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per DAS28 (hsCRP) at Week 12

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End point title

LDA or CR Response Rate per DAS28 (hsCRP) at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	50 (35.5 to 64.5)	35.1 (21.8 to 51.3)	56.4 (41 to 70.7)	52.5 (37.5 to 67.1)	48.7 (41.1 to 56.5)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per DAS28 (hsCRP) at Week 16

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End point title

LDA or CR Response Rate per DAS28 (hsCRP) at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	36	37	39	153
Units: percentage of participants
number (confidence interval 95%)	51.2 (36.5 to 65.7)	52.8 (37 to 68)	62.2 (46.1 to 76)	48.7 (33.9 to 63.8)	53.6 (45.7 to 61.3)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per DAS28 (hsCRP) at Week 20

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End point title

LDA or CR Response Rate per DAS28 (hsCRP) at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	54.8 (39.9 to 68.8)	55.6 (39.6 to 70.5)	56.4 (41 to 70.7)	60 (44.6 to 73.7)	56.7 (48.9 to 64.2)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per DAS28 (hsCRP) at Week 24

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End point title

LDA or CR Response Rate per DAS28 (hsCRP) at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	61.9 (46.8 to 75)	44.4 (29.5 to 60.4)	56.4 (41 to 70.7)	60 (44.6 to 73.7)	56.1 (48.2 to 63.6)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per DAS28 (hsCRP) at Week 28

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End point title

LDA or CR Response Rate per DAS28 (hsCRP) at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	47.6 (33.4 to 62.3)	41.7 (27.1 to 57.8)	56.4 (41 to 70.7)	55 (39.8 to 69.3)	50.3 (42.6 to 58)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per DAS28 (hsCRP) at Week 32

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End point title

LDA or CR Response Rate per DAS28 (hsCRP) at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	52.4 (37.7 to 66.6)	52.8 (37 to 68)	61.5 (45.9 to 75.1)	60 (44.6 to 73.7)	56.7 (48.9 to 64.2)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per DAS28 (hsCRP) at Week 36

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End point title

LDA or CR Response Rate per DAS28 (hsCRP) at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	54.8 (39.9 to 68.8)	41.7 (27.1 to 57.8)	59 (43.4 to 72.9)	47.5 (32.9 to 62.5)	51 (43.2 to 58.7)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 2

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End point title

CR Response Rate Per DAS28 (hsCRP) at Week 2

End point description

Percentage of subjects achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	37	39	39	155
Units: percentage of participants
number (confidence interval 95%)	5 (0.5 to 17.4)	5.4 (0.6 to 18.6)	12.8 (5.1 to 27.2)	10.3 (3.5 to 24.2)	8.4 (4.9 to 13.9)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 4

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End point title

CR Response Rate Per DAS28 (hsCRP) at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	14.3 (6.3 to 28.2)	8.1 (2.1 to 22)	23.1 (12.4 to 38.5)	25 (14 to 40.4)	17.7 (12.5 to 24.5)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 6

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End point title

CR Response Rate Per DAS28 (hsCRP) at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	31 (19 to 46.1)	18.9 (9.2 to 34.5)	33.3 (20.6 to 49.1)	27.5 (16 to 43)	27.8 (21.4 to 35.3)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 8

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End point title

CR Response Rate Per DAS28 (hsCRP) at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	28.6 (17.1 to 43.7)	21.6 (11.1 to 37.4)	38.5 (24.9 to 54.1)	37.5 (24.2 to 53)	31.6 (24.9 to 39.3)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 12

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End point title

CR Response Rate Per DAS28 (hsCRP) at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	31 (19 to 46.1)	21.6 (11.1 to 37.4)	38.5 (24.9 to 54.1)	40 (26.3 to 55.4)	32.9 (26.1 to 40.6)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 16

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End point title

CR Response Rate Per DAS28 (hsCRP) at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	41	36	37	39	153
Units: percentage of participants
number (confidence interval 95%)	39 (25.6 to 54.3)	30.6 (17.9 to 47)	37.8 (24 to 53.9)	30.8 (18.5 to 46.5)	34.6 (27.6 to 42.5)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 20

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End point title

CR Response Rate Per DAS28 (hsCRP) at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	40.5 (27 to 55.5)	36.1 (22.4 to 52.5)	25.6 (14.4 to 41.2)	37.5 (24.2 to 53)	35 (28 to 42.8)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 24

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End point title

CR Response Rate Per DAS28 (hsCRP) at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	33.3 (20.9 to 48.5)	30.6 (17.9 to 47)	38.5 (24.9 to 54.1)	45 (30.7 to 60.2)	36.9 (29.8 to 44.7)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 28

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End point title

CR Response Rate Per DAS28 (hsCRP) at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	33.3 (20.9 to 48.5)	27.8 (15.7 to 44.1)	38.5 (24.9 to 54.1)	42.5 (28.5 to 57.8)	35.7 (28.6 to 43.4)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 32

Top of page

End point title

CR Response Rate Per DAS28 (hsCRP) at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	38.1 (25 to 53.2)	38.9 (24.8 to 55.2)	35.9 (22.7 to 51.6)	45 (30.7 to 60.2)	39.5 (32.2 to 47.3)

No statistical analyses for this end point

Secondary: CR Response Rate Per DAS28 (hsCRP) at Week 36

Top of page

End point title

CR Response Rate Per DAS28 (hsCRP) at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	38.1 (25 to 53.2)	19.4 (9.4 to 35.3)	43.6 (29.3 to 59)	37.5 (24.2 to 53)	35 (28 to 42.8)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 2

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End point title

LDA or CR Response Rate per CDAI at Week 2

End point description

Percentage of subjects achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	39	37	39	39	154
Units: percentage of participants
number (confidence interval 95%)	7.7 (1.9 to 21)	5.4 (0.6 to 18.6)	12.8 (5.1 to 27.2)	15.4 (6.9 to 30.1)	10.4 (6.4 to 16.3)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 4

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End point title

LDA or CR Response Rate per CDAI at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	23.8 (13.3 to 38.7)	21.6 (11.1 to 37.4)	23.1 (12.4 to 38.5)	35 (22.1 to 50.5)	25.9 (19.7 to 33.3)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 6

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End point title

LDA or CR Response Rate per CDAI at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	40.5 (27 to 55.5)	21.6 (11.1 to 37.4)	43.6 (29.3 to 59)	45 (30.7 to 60.2)	38 (30.8 to 45.7)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 8

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End point title

LDA or CR Response Rate per CDAI at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	35.7 (22.9 to 50.9)	27 (15.2 to 43.1)	46.2 (31.6 to 61.4)	47.5 (32.9 to 62.5)	39.2 (32 to 47)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 12

Top of page

End point title

LDA or CR Response Rate per CDAI at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	40.5 (27 to 55.5)	37.8 (24 to 53.9)	46.2 (31.6 to 61.4)	50 (35.2 to 64.8)	43.7 (36.2 to 51.5)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 16

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End point title

LDA or CR Response Rate per CDAI at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	35	36	38	149
Units: percentage of participants
number (confidence interval 95%)	47.5 (32.9 to 62.5)	45.7 (30.5 to 61.8)	55.6 (39.6 to 70.5)	50 (34.8 to 65.2)	49.7 (41.7 to 57.6)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 20

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End point title

LDA or CR Response Rate per CDAI at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	35	38	39	154
Units: percentage of participants
number (confidence interval 95%)	47.6 (33.4 to 62.3)	45.7 (30.5 to 61.8)	36.8 (23.3 to 52.8)	56.4 (41 to 70.7)	46.8 (39 to 54.6)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 24

Top of page

End point title

LDA or CR Response Rate per CDAI at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	54.8 (39.9 to 68.8)	44.4 (29.5 to 60.4)	43.6 (29.3 to 59)	60 (44.6 to 73.7)	51 (43.2 to 58.7)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 28

Top of page

End point title

LDA or CR Response Rate per CDAI at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	47.6 (33.4 to 62.3)	44.4 (29.5 to 60.4)	48.7 (33.9 to 63.8)	60 (44.6 to 73.7)	50.3 (42.6 to 58)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 32

Top of page

End point title

LDA or CR Response Rate per CDAI at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	42.9 (29.1 to 57.8)	55.6 (39.6 to 70.5)	51.3 (36.2 to 66.1)	60 (44.6 to 73.7)	52.2 (44.5 to 59.9)

No statistical analyses for this end point

Secondary: LDA or CR Response Rate per CDAI at Week 36

Top of page

End point title

LDA or CR Response Rate per CDAI at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	52.4 (37.7 to 66.6)	44.4 (29.5 to 60.4)	59 (43.4 to 72.9)	60 (44.6 to 73.7)	54.1 (46.3 to 61.7)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 2

Top of page

End point title

CR Response Rate Per CDAI Criteria at Week 2

End point description

Percentage of subjects achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method. Safety Analysis Set: all subjects who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF used for missing data.

End point type

Secondary

End point timeframe

Week 2 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	39	37	39	39	154
Units: percentage of participants
number (confidence interval 95%)	0 (0 to 10.7)	0 (0 to 11.2)	2.6 (0 to 14.4)	0 (0 to 10.7)	0.6 (0 to 4)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 4

Top of page

End point title

CR Response Rate Per CDAI Criteria at Week 4

End point description

End point type

Secondary

End point timeframe

Week 4 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	0 (0 to 10)	2.7 (0 to 15.1)	5.1 (0.5 to 17.8)	5 (0.5 to 17.4)	3.2 (1.2 to 7.4)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 6

Top of page

End point title

CR Response Rate Per CDAI Criteria at Week 6

End point description

End point type

Secondary

End point timeframe

Week 6 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	2.4 (0 to 13.4)	0 (0 to 11.2)	10.3 (3.5 to 24.2)	5 (0.5 to 17.4)	4.4 (2 to 9)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 8

Top of page

End point title

CR Response Rate Per CDAI Criteria at Week 8

End point description

End point type

Secondary

End point timeframe

Week 8 of Study M12-963

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	4.8 (0.5 to 16.6)	0 (0 to 11.2)	17.9 (8.7 to 33)	17.5 (8.4 to 32.3)	10.1 (6.2 to 15.9)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 12

Top of page

End point title

CR Response Rate Per CDAI Criteria at Week 12

End point description

End point type

Secondary

End point timeframe

Week 12 of Study M12-963 (considered Week 0 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	37	39	40	158
Units: percentage of participants
number (confidence interval 95%)	7.1 (1.8 to 19.7)	8.1 (2.1 to 22)	12.8 (5.1 to 27.2)	12.5 (5 to 26.6)	10.1 (6.2 to 15.9)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 16

Top of page

End point title

CR Response Rate Per CDAI Criteria at Week 16

End point description

End point type

Secondary

End point timeframe

Week 16 (Week 4 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	40	35	36	38	149
Units: percentage of participants
number (confidence interval 95%)	7.5 (1.9 to 20.6)	5.7 (0.6 to 19.6)	11.1 (3.8 to 25.9)	15.8 (7.1 to 30.8)	10.1 (6.1 to 16)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 20

Top of page

End point title

CR Response Rate Per CDAI Criteria at Week 20

End point description

End point type

Secondary

End point timeframe

Week 20 (Week 8 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	35	38	39	154
Units: percentage of participants
number (confidence interval 95%)	9.5 (3.2 to 22.6)	11.4 (3.9 to 26.5)	15.8 (7.1 to 30.8)	17.9 (8.7 to 33)	13.6 (9 to 20)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 24

Top of page

End point title

CR Response Rate Per CDAI Criteria at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24 (Week 12 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	7.1 (1.8 to 19.7)	5.6 (0.6 to 19.1)	23.1 (12.4 to 38.5)	20 (10.2 to 35)	14 (9.4 to 20.4)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 28

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End point title

CR Response Rate Per CDAI Criteria at Week 28

End point description

End point type

Secondary

End point timeframe

Week 28 (Week 16 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	9.5 (3.2 to 22.6)	5.6 (0.6 to 19.1)	20.5 (10.5 to 35.8)	20 (10.2 to 35)	14 (9.4 to 20.4)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 32

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End point title

CR Response Rate Per CDAI Criteria at Week 32

End point description

End point type

Secondary

End point timeframe

Week 32 (Week 20 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	7.1 (1.8 to 19.7)	5.6 (0.6 to 19.1)	12.8 (5.1 to 27.2)	15 (6.7 to 29.5)	10.2 (6.3 to 16)

No statistical analyses for this end point

Secondary: CR Response Rate Per CDAI Criteria at Week 36

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End point title

CR Response Rate Per CDAI Criteria at Week 36

End point description

End point type

Secondary

End point timeframe

Week 36 (Week 24 of Study M12-965)

End point values	ADA 40 mg EOW / ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Number of subjects analysed	42	36	39	40	157
Units: percentage of participants
number (confidence interval 95%)	9.5 (3.2 to 22.6)	11.1 (3.8 to 25.9)	17.9 (8.7 to 33)	15 (6.7 to 29.5)	13.4 (8.8 to 19.7)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Protocol-related treatment-emergent AEs (TEAEs) and Treatment-emergent serious adverse events (TESAEs) were collected from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks).

Adverse event reporting additional description

A protocol-related TEAE or TESAE is defined as any AE with onset or worsening reported by a participant from the first dose of study drug in study M12-965 until 70 days have elapsed following discontinuation of ABT-122 administration. Events were collected whether elicited or spontaneously reported by the participant.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

ADA 40 mg EOW/ABT-122 120 mg EOW

Reporting group description

Double-blind ADA 40 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group title

ABT-122 60 mg EOW / 120 mg EOW

Reporting group description

Double-blind ABT-122 60 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group title

ABT-122 120 mg EOW / 120 mg EOW

Reporting group description

Double-blind ABT-122 120 mg EOW for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group title

ABT-122 120 mg EW / 120 mg EOW

Reporting group description

Double-blind ABT-122 120 mg EW for 11 weeks. Open-label ABT-122 120 mg EOW.

Reporting group title

All ABT-122 120 mg EOW

Reporting group description

Open-label ABT-122 120 mg EOW.

Serious adverse events	ADA 40 mg EOW/ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	5 / 39 (12.82%)	0 / 40 (0.00%)	6 / 158 (3.80%)
number of deaths (all causes)	0	0	0	0	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
HUMERUS FRACTURE
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
INFLAMMATION OF WOUND
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
JOINT DISLOCATION
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
MYOCARDIAL ISCHAEMIA
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
ENTEROCOLITIS
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
MENORRHAGIA
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
SKIN ULCER
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	ADA 40 mg EOW/ABT-122 120 mg EOW	ABT-122 60 mg EOW / 120 mg EOW	ABT-122 120 mg EOW / 120 mg EOW	ABT-122 120 mg EW / 120 mg EOW	All ABT-122 120 mg EOW
Total subjects affected by non serious adverse events
subjects affected / exposed	17 / 42 (40.48%)	14 / 37 (37.84%)	16 / 39 (41.03%)	14 / 40 (35.00%)	61 / 158 (38.61%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
Vascular disorders
HYPERTENSION
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	1 / 40 (2.50%)	2 / 158 (1.27%)
occurrences all number	0	0	1	1	2
HAEMATOMA
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
VARICOSE VEIN
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
General disorders and administration site conditions
NODULE
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
Immune system disorders
FOOD ALLERGY
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	2	2
HYPERSENSITIVITY
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	1 / 40 (2.50%)	2 / 158 (1.27%)
occurrences all number	0	1	0	1	2
Reproductive system and breast disorders
ADNEXA UTERI CYST
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
OVARIAN CYST
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
Investigations
ALANINE AMINOTRANSFERASE ABNORMAL
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
ALANINE AMINOTRANSFERASE INCREASED
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	2 / 158 (1.27%)
occurrences all number	1	0	1	0	2
ASPARTATE AMINOTRANSFERASE INCREASED
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	2 / 158 (1.27%)
occurrences all number	2	0	1	0	3
BLOOD CHOLESTEROL INCREASED
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	2 / 158 (1.27%)
occurrences all number	1	0	0	1	2
BLOOD SODIUM DECREASED
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
BLOOD TRIGLYCERIDES INCREASED
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	2 / 158 (1.27%)
occurrences all number	1	0	0	1	2
EOSINOPHIL COUNT INCREASED
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
HAEMOGLOBIN DECREASED
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
HEPATIC ENZYME INCREASED
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
LIVER FUNCTION TEST ABNORMAL
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
TRANSAMINASES INCREASED
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
Injury, poisoning and procedural complications
CHEST INJURY
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
CONTUSION
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
LIMB INJURY
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
RIB FRACTURE
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
SKIN ABRASION
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
SUBCUTANEOUS HAEMATOMA
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
THERMAL BURN
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
Nervous system disorders
DIZZINESS
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	1 / 39 (2.56%)	0 / 40 (0.00%)	2 / 158 (1.27%)
occurrences all number	0	1	1	0	2
Ear and labyrinth disorders
VERTIGO
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
DENTAL CARIES
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
GASTRITIS
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
NAUSEA
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
VOMITING
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	1 / 39 (2.56%)	0 / 40 (0.00%)	2 / 158 (1.27%)
occurrences all number	0	1	1	0	2
Hepatobiliary disorders
HEPATIC STEATOSIS
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
HEPATOBILIARY DISEASE
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
LIVER DISORDER
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
PRURITUS
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
NAIL DISCOLOURATION
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
RASH
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
RASH PRURITIC
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
RASH VESICULAR
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
Renal and urinary disorders
NEPHROLITHIASIS
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	2 / 42 (4.76%)	1 / 37 (2.70%)	4 / 39 (10.26%)	2 / 40 (5.00%)	9 / 158 (5.70%)
occurrences all number	2	1	4	2	9
ARTHRITIS
subjects affected / exposed	2 / 42 (4.76%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	2 / 158 (1.27%)
occurrences all number	4	0	0	0	4
INTERVERTEBRAL DISC DEGENERATION
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
BURSITIS
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
MUSCULOSKELETAL PAIN
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	1 / 40 (2.50%)	2 / 158 (1.27%)
occurrences all number	0	0	1	1	2
OSTEOARTHRITIS
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	1 / 39 (2.56%)	1 / 40 (2.50%)	3 / 158 (1.90%)
occurrences all number	0	1	1	1	3
OSTEOPOROSIS
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
PAIN IN EXTREMITY
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	2 / 39 (5.13%)	0 / 40 (0.00%)	2 / 158 (1.27%)
occurrences all number	0	0	3	0	3
RHEUMATOID ARTHRITIS
subjects affected / exposed	0 / 42 (0.00%)	3 / 37 (8.11%)	1 / 39 (2.56%)	0 / 40 (0.00%)	4 / 158 (2.53%)
occurrences all number	0	3	1	0	4
TENDON DISORDER
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
Infections and infestations
ATYPICAL PNEUMONIA
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
BRONCHITIS
subjects affected / exposed	0 / 42 (0.00%)	3 / 37 (8.11%)	0 / 39 (0.00%)	0 / 40 (0.00%)	3 / 158 (1.90%)
occurrences all number	0	3	0	0	3
CYSTITIS
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
HERPES VIRUS INFECTION
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
NASOPHARYNGITIS
subjects affected / exposed	4 / 42 (9.52%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	4 / 158 (2.53%)
occurrences all number	6	0	0	0	6
ORAL HERPES
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
PARAMETRITIS
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
PARONYCHIA
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	1 / 158 (0.63%)
occurrences all number	0	0	0	1	1
PHARYNGITIS
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	1 / 40 (2.50%)	2 / 158 (1.27%)
occurrences all number	1	0	0	1	2
PNEUMONIA
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
PULPITIS DENTAL
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
RASH PUSTULAR
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
RESPIRATORY TRACT INFECTION
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
SINUSITIS
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	0	1	0	1
TONSILLITIS
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	1 / 42 (2.38%)	3 / 37 (8.11%)	6 / 39 (15.38%)	5 / 40 (12.50%)	15 / 158 (9.49%)
occurrences all number	1	3	10	7	21
URINARY TRACT INFECTION
subjects affected / exposed	0 / 42 (0.00%)	0 / 37 (0.00%)	1 / 39 (2.56%)	1 / 40 (2.50%)	2 / 158 (1.27%)
occurrences all number	0	0	1	2	3
VARICELLA
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
VIRAL UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
DIABETES MELLITUS
subjects affected / exposed	0 / 42 (0.00%)	1 / 37 (2.70%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	0	1	0	0	1
HYPERLIPIDAEMIA
subjects affected / exposed	1 / 42 (2.38%)	0 / 37 (0.00%)	0 / 39 (0.00%)	0 / 40 (0.00%)	1 / 158 (0.63%)
occurrences all number	1	0	0	0	1

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Were there any global substantial amendments to the protocol? Yes

01 May 2015

● Revised the investigational plan to include self-administration of ABT-122 once the prefilled syringe (PFS) was approved and the subject was trained on self-administration. Once self-administration began, site visits were allowed to occur monthly rather than EOW. ● Updated inclusion criteria concerning female and male reproductive language to be consistent with updated safety language. ● Updated the electrocardiogram procedure to clarify that a 12-lead electrocardiogram (ECG) was to be obtained at the timepoint indicated in the Table of Study Activities (Week 24). ● Removed the 24-hour methylhistamine laboratory tests in the evaluation of a hypersensitivity reaction and urine drug screen. ● Added injection site reaction language to allow sites to further assess and investigate skin reactions (e.g., photographs or skin biopsies). An injection site assessment was to be completed by the investigator only for an injection site reaction. ● Updated the study drug section to describe the PFS, in order to enable a more convenient drug self-administration and to eliminate the site burden of reconstituting ABT-122. ● Added investigational product information for the ABT-122 solution for PFS, including related information (e.g., packaging and labeling, storage). ● Added written instructions for self-administration and dosing diary to allow subjects to follow site training on self-administration and to allow the subject to document dosing information on a subject diary.

29 Sep 2015

● Revised to reflect the: increase in planned enrollment from 160 to 225, to reflect the update in planned enrollment into RCT Study M12-963; increase in the number of randomized subjects from approximately 80 to approximately 160, to allow all subjects enrolled in Study M12-963 to enroll in the OLE Study M13-965; decrease in the number of study sites from approximately 60 to approximately 32, i.e. those sites that enrolled subjects into Study M12-963 ● Added new standard medical and nonmedical complaint language. ● Updated the ABT-122 PFS dosing instructions.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: American College of Rheumatology (ACR) 20 Response Rate at Week 2

Primary: American College of Rheumatology (ACR) 20 Response Rate at Week 2

Primary: ACR20 Response Rate at Week 4

Primary: ACR20 Response Rate at Week 4

Primary: ACR20 Response Rate at Week 6

Primary: ACR20 Response Rate at Week 6

Primary: ACR20 Response Rate at Week 8

Primary: ACR20 Response Rate at Week 8

Primary: ACR20 Response Rate at Week 12

Primary: ACR20 Response Rate at Week 12

Primary: ACR20 Response Rate at Week 16

Primary: ACR20 Response Rate at Week 16

Primary: ACR20 Response Rate at Week 20

Primary: ACR20 Response Rate at Week 20

Primary: ACR20 Response Rate at Week 24

Primary: ACR20 Response Rate at Week 24

Primary: ACR20 Response Rate at Week 28

Primary: ACR20 Response Rate at Week 28

Primary: ACR20 Response Rate at Week 32

Primary: ACR20 Response Rate at Week 32

Primary: ACR20 Response Rate at Week 36

Primary: ACR20 Response Rate at Week 36

Primary: ACR50 Response Rate at Week 2

Primary: ACR50 Response Rate at Week 2

Primary: ACR50 Response Rate at Week 4

Primary: ACR50 Response Rate at Week 4

Primary: ACR50 Response Rate at Week 6

Primary: ACR50 Response Rate at Week 6

Primary: ACR50 Response Rate at Week 8

Primary: ACR50 Response Rate at Week 8

Primary: ACR50 Response Rate at Week 12

Primary: ACR50 Response Rate at Week 12

Primary: ACR50 Response Rate at Week 16

Primary: ACR50 Response Rate at Week 16

Primary: ACR50 Response Rate at Week 20

Primary: ACR50 Response Rate at Week 20

Primary: ACR50 Response Rate at Week 24

Primary: ACR50 Response Rate at Week 24

Primary: ACR50 Response Rate at Week 28

Primary: ACR50 Response Rate at Week 28

Primary: ACR50 Response Rate at Week 32

Primary: ACR50 Response Rate at Week 32

Primary: ACR50 Response Rate at Week 36

Primary: ACR50 Response Rate at Week 36

Primary: ACR70 Response Rate at Week 2

Primary: ACR70 Response Rate at Week 2

Primary: ACR70 Response Rate at Week 4

Primary: ACR70 Response Rate at Week 4

Primary: ACR70 Response Rate at Week 6

Primary: ACR70 Response Rate at Week 6

Primary: ACR70 Response Rate at Week 8

Primary: ACR70 Response Rate at Week 8

Primary: ACR70 Response Rate at Week 12

Primary: ACR70 Response Rate at Week 12

Primary: ACR70 Response Rate at Week 16

Primary: ACR70 Response Rate at Week 16

Primary: ACR70 Response Rate at Week 20

Primary: ACR70 Response Rate at Week 20

Primary: ACR70 Response Rate at Week 24

Primary: ACR70 Response Rate at Week 24

Primary: ACR70 Response Rate at Week 28

Primary: ACR70 Response Rate at Week 28

Primary: ACR70 Response Rate at Week 32

Primary: ACR70 Response Rate at Week 32

Primary: ACR70 Response Rate at Week 36

Primary: ACR70 Response Rate at Week 36

Primary: Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths

Primary: Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths

Secondary: Change From Baseline In Tender Joint Count (TJC68) at Week 2

Secondary: Change From Baseline In Tender Joint Count (TJC68) at Week 2

Clinical Trial Results:
Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)