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Clinical Trial Results:
A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis

Summary
EudraCT number	2022-001066-36
Trial protocol	PL
Global end of trial date	23 Nov 2023

Results information
Results version number	v1(current)
This version publication date	08 Dec 2024
First version publication date	08 Dec 2024
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

CT-P47 3.1

ISRCTN number

US NCT number

NCT05489224

WHO universal trial number (UTN)

Sponsor organisation name

CELLTRION, Inc.

Sponsor organisation address

Cenral-ro 263, Incheon, Korea, Republic of,

Public contact

Clinical Planning 3 Department, CELLTRION, Inc., +82 328504167, JeeHye.Suh@celltrion.com

Scientific contact

Clinical Planning 3 Department, CELLTRION, Inc., +82 328504167, JeeHye.Suh@celltrion.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

16 May 2024

Is this the analysis of the primary completion data?

Yes

Primary completion date

29 Jun 2023

Global end of trial reached?

Yes

Global end of trial date

23 Nov 2023

Was the trial ended prematurely?

Main objective of the trial

To demonstrate that CT-P47 is equivalent to RoActemra, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity measured by Disease Activity Score using 28 joint counts (DAS28) (Erythrocyte-Sedimentation Rate [ESR]) at Week 12.

Protection of trial subjects

The study was performed following the ethical principles that have their origin in the Declaration of Helsinki (WMA 2013), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) harmonised tripartite guideline E6 (R2): Good Clinical Practice (GCP), and all applicable regulations. All investigators agreed to conduct all aspects of this study by national, state, local laws and regulations. For hypersensitivity monitoring, vital signs (including systolic and diastolic BP, heart rate, respiratory rate, and body temperature) was monitored before beginning of the study drug administration (within 15 minutes) and at 1 hour (±15 minutes) after the end of the study drug administration. In addition, any type of ECG was performed for hypersensitivity monitoring 1 hour (±15 minutes) after the end of the study drug administration. Emergency equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory support including inhalational therapy, oxygen, and artificial ventilator was available. For patients who experience anaphylaxis or other serious treatment-related hypersensitivity reaction, study drug was to be stopped immediately and the patient discontinued from the study drug.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Sep 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 471

Worldwide total number of subjects

471

EEA total number of subjects

471

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)

365

From 65 to 84 years

106

85 years and over

Subject disposition

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Recruitment details

The recruitment was conducted in 22 study centers in Poland.

Screening details

The screening period was up to 42 days. Male or female patient aged 18-75 years with moderate to severe active rheumatoid arthirits for at least 24 weeks was eligible to be enrolled.

Period 1 title

Treatment Period I (Week 0 to Week 24)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Blinding implementation details

The investigators, patients, and other predefined personnel from the sponsor and CRO teams remained blinded until the EOS.

Are arms mutually exclusive

Yes

CT-P47

Arm description

Patients who were initially randomly assigned to CT-P47 in Treatment Period I

Arm type

Experimental

Investigational medicinal product name

CT-P47

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Multiple dose (8 mg/kg, not exceeding 800 mg/dose) of CT-P47 by IV Q4W, co administered with MTX between 10 to 25 mg/week, oral or parenteral; IM or SC dose (dose and route must be maintained from beginning to end of the study) and folic acid (≥5 mg/week, oral dose)

RoActemra

Arm description

Patients who were initially randomly assigned to RoActemra in Treatment Period I

Arm type

Active comparator

Investigational medicinal product name

EU-approved RoActemra

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Multiple dose (8 mg/kg, not exceeding 800 mg/dose) of EU-approved RoActemra by IV Q4W, co administered with MTX between 10 to 25 mg/week, oral or parenteral; IM or SC dose (dose and route must be maintained from beginning to end of the study) and folic acid (≥5 mg/week, oral dose)

Number of subjects in period 1	CT-P47	RoActemra
Started	234	237
Completed	225	219
Not completed	9	18
Consent withdrawn by subject	6	5
Physician decision	-	1
Adverse event, non-fatal	3	11
Lost to follow-up	-	1

Period 2 title

Treatment Period II (Week 24 to Week 52)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Blinding implementation details

The investigators, patients, and other predefined personnel from the sponsor and CRO teams remained blinded until the EOS.

Are arms mutually exclusive

Yes

CT-P47 Maintenance

Arm description

All patients who received CT-P47 in Treatment Period I and continued to receive CT-P47 in Treatment Period II

Arm type

Experimental

Investigational medicinal product name

CT-P47

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

RoActemra Maintenance

Arm description

Patients who received RoActemra in Treatment Period I and re-randomized to continue RoActemra in Treatment Period II

Arm type

Active comparator

Investigational medicinal product name

EU-approved RoActemra

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Switched to CT-P47

Arm description

Patients who received RoActemra in Treatment Period I and re-randomized to receive CT-P47 in Treatment Period II

Arm type

Experimental

Investigational medicinal product name

CT-P47

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Number of subjects in period 2	CT-P47 Maintenance	RoActemra Maintenance	Switched to CT-P47
Started	225	109	110
Completed	211	100	102
Not completed	14	9	8
Consent withdrawn by subject	3	3	4
Physician decision	1	-	-
Adverse event, non-fatal	10	5	4
Lost to follow-up	-	1	-

Baseline characteristics

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Reporting group title

CT-P47

Reporting group description

Patients who were initially randomly assigned to CT-P47 in Treatment Period I

Reporting group title

RoActemra

Reporting group description

Patients who were initially randomly assigned to RoActemra in Treatment Period I

Reporting group values	CT-P47	RoActemra	Total
Number of subjects	234	237	471
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	180	185	365
From 65-84 years	54	52	106
85 years and over	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	55.1 ( 10.98 )	54.4 ( 11.61 )	-
Gender categorical
Units: Subjects
Female	181	180	361
Male	53	57	110
Body Weight on Day 1
Units: Subjects
<100 kg	208	210	418
≥100 kg	26	27	53
DAS28 (ESR) score at Screening
Units: Subjects
DAS28 (ESR) >5.1	229	230	459
DAS28 (ESR) ≤5.1	5	7	12
Prior biologic use approved for RA treatment
Units: Subjects
Yes	58	62	120
No	176	175	351
Ethnicity
Units: Subjects
Hispanic or Latino	6	4	10
Non-Hispanic or Non-Latino	228	233	461

End points

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Reporting group title

CT-P47

Reporting group description

Patients who were initially randomly assigned to CT-P47 in Treatment Period I

Reporting group title

RoActemra

Reporting group description

Patients who were initially randomly assigned to RoActemra in Treatment Period I

Reporting group title

CT-P47 Maintenance

Reporting group description

All patients who received CT-P47 in Treatment Period I and continued to receive CT-P47 in Treatment Period II

Reporting group title

RoActemra Maintenance

Reporting group description

Patients who received RoActemra in Treatment Period I and re-randomized to continue RoActemra in Treatment Period II

Reporting group title

Switched to CT-P47

Reporting group description

Patients who received RoActemra in Treatment Period I and re-randomized to receive CT-P47 in Treatment Period II

Primary: Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 12 - ITT set

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End point title

Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 12 - ITT set

End point description

The DAS28(ESR) score was derived using the following formulae: DAS28 (ESR)=(0.56 ×√TJC28)+(0.28 × √SJC28)+(0.70 × ln[ESR])+(0.014 ×GH) Where: • TJC28 = number of tender joints (0-28): tender joint count (TJC) • SJC28 = number of swollen joints (0-28): swollen joint count (SJC) • ESR = ESR measurement (mm/hour) • GH = patient's global disease activity measured on VAS (mm: 0-100) DAS28 (ESR) values could be ranged from 0 to 10 while higher values mean a higher disease activity.

End point type

Primary

End point timeframe

Week 12

End point values	CT-P47	RoActemra
Number of subjects analysed	221	225
Units: score
least squares mean (standard error)	-3.01 ( 0.121 )	-3.00 ( 0.120 )

CT-P47 vs. EU-approved RoActemra - 95% CI

Statistical analysis description

An ANCOVA comparing the change from baseline of DAS28 (ESR) at Week 12 between two treatment groups were conducted considering the treatment as fixed effect, and body weight (<100 kg or ≥100 kg) measured on Day 1, baseline DAS28 (ESR) score and prior biologic use approved for RA treatment (yes or no) as covariates.

Comparison groups

CT-P47 v RoActemra

Number of subjects included in analysis

446

Analysis specification

Pre-specified

Analysis type

equivalence ^[1]

Method

Parameter type

Difference of Least square means

Point estimate

-0.01

Confidence interval

level

95%

sides

2-sided

lower limit

-0.26

upper limit

0.24

Notes
[1] - The pre-specified equivalence margin is ±0.6.

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 24 - ITT set

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End point title

Mean Change From Baseline in DAS28 (ESR) at Week 24 - ITT set

End point description

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P47	RoActemra
Number of subjects analysed	222	223
Units: score
arithmetic mean (standard deviation)	-3.858 ( 1.2402 )	-3.720 ( 1.3945 )

No statistical analyses for this end point

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 32 - ITT - Treatment Period II subset

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End point title

Mean Change From Baseline in DAS28 (ESR) at Week 32 - ITT - Treatment Period II subset

End point description

End point type

Secondary

End point timeframe

Week 32

End point values	CT-P47 Maintenance	RoActemra Maintenance	Switched to CT-P47
Number of subjects analysed	219	104	105
Units: score
arithmetic mean (standard deviation)	-3.921 ( 1.2548 )	-3.994 ( 1.1753 )	-4.218 ( 1.1380 )

No statistical analyses for this end point

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 52 - ITT - Treatment Period II subset

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End point title

Mean Change From Baseline in DAS28 (ESR) at Week 52 - ITT - Treatment Period II subset

End point description

End point type

Secondary

End point timeframe

Week 52

End point values	CT-P47 Maintenance	RoActemra Maintenance	Switched to CT-P47
Number of subjects analysed	218	103	106
Units: score
arithmetic mean (standard deviation)	-4.279 ( 1.1934 )	-4.231 ( 1.3046 )	-4.376 ( 1.4212 )

No statistical analyses for this end point

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 12 - ITT set

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End point title

ACR20, ACR50, and ACR70 Response Rate at Week 12 - ITT set

End point description

ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). ACR50 and ACR70 are the same instruments with improvement levels defined as 50% and 70% respectively versus 20% for ACR20.

End point type

Secondary

End point timeframe

Week 12

End point values	CT-P47	RoActemra
Number of subjects analysed	234	237
Units: participants
ACR20	185	175
ACR50	102	106
ACR70	46	54

No statistical analyses for this end point

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 24 - ITT set

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End point title

ACR20, ACR50, and ACR70 Response Rate at Week 24 - ITT set

End point description

End point type

Secondary

End point timeframe

Week 24

End point values	CT-P47	RoActemra
Number of subjects analysed	234	237
Units: participants
ACR20	199	189
ACR50	142	146
ACR70	100	99

No statistical analyses for this end point

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 32 - ITT - Treatment Period II subset

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End point title

ACR20, ACR50, and ACR70 Response Rate at Week 32 - ITT - Treatment Period II subset

End point description

End point type

Secondary

End point timeframe

Week 32

End point values	CT-P47 Maintenance	RoActemra Maintenance	Switched to CT-P47
Number of subjects analysed	225	109	110
Units: participants
ACR20	199	96	98
ACR50	148	79	77
ACR70	91	47	61

No statistical analyses for this end point

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 52 - ITT - Treatment Period II subset

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End point title

ACR20, ACR50, and ACR70 Response Rate at Week 52 - ITT - Treatment Period II subset

End point description

End point type

Secondary

End point timeframe

Week 52

End point values	CT-P47 Maintenance	RoActemra Maintenance	Switched to CT-P47
Number of subjects analysed	225	109	110
Units: participants
ACR20	211	97	100
ACR50	174	88	87
ACR70	123	64	63

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events were assessed from the date the patient signed the Informed Consent Form (ICF) until 4 weeks after the last study drug administration (up to 52 weeks [End-of-study visit]).

Adverse event reporting additional description

Treatment Period I: From Week 0 to prior to the 1st dosing in Treatment Period II. Treatment Period II: On or after the 1st dosing in Treatment Period II.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.0

Reporting group title

Treatment Period I: CT-P47

Reporting group description

Patients who were initially randomly assigned to CT-P47 in Treatment Period I

Reporting group title

Treatment Period I: RoActemra

Reporting group description

Patients who were initially randomly assigned to RoActemra in Treatment Period I

Reporting group title

Treatment Period II: CT-P47 Maintenance

Reporting group description

Patients who received CT-P47 during Treatment Period I and continued to receive CT-P47 in Treatment Period II

Reporting group title

Treatment Period II: RoActemra Maintenance

Reporting group description

Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to continue to receive RoActemra in Treatment Period II

Reporting group title

Treatment Period II: Switched to CT-P47

Reporting group description

Patients who were initially randomly assigned to RoActemra at Day 1 (Week 0) and re-randomized (1:1 ratio) at Week 24 to undergo transition to CT-P47 in Treatment Period II

Serious adverse events	Treatment Period I: CT-P47	Treatment Period I: RoActemra	Treatment Period II: CT-P47 Maintenance	Treatment Period II: RoActemra Maintenance	Treatment Period II: Switched to CT-P47
Total subjects affected by serious adverse events
subjects affected / exposed	10 / 234 (4.27%)	9 / 237 (3.80%)	11 / 225 (4.89%)	8 / 109 (7.34%)	6 / 110 (5.45%)
number of deaths (all causes)	0	0	1	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
subjects affected / exposed	0 / 234 (0.00%)	1 / 237 (0.42%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningioma benign
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	1 / 109 (0.92%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Extremity necrosis
subjects affected / exposed	0 / 234 (0.00%)	1 / 237 (0.42%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Venous thrombosis limb
subjects affected / exposed	1 / 234 (0.43%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Peripheral swelling
subjects affected / exposed	1 / 234 (0.43%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chest pain
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	1 / 109 (0.92%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Cervical cyst
subjects affected / exposed	1 / 234 (0.43%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endometrial hyperplasia
subjects affected / exposed	0 / 234 (0.00%)	1 / 237 (0.42%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rectocele
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Uterine hemorrhage
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	1 / 110 (0.91%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleural effusion
subjects affected / exposed	1 / 234 (0.43%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	1 / 110 (0.91%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Schizophrenia
subjects affected / exposed	1 / 234 (0.43%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Interferon gamma release assay positive
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Femur fracture
subjects affected / exposed	0 / 234 (0.00%)	1 / 237 (0.42%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ankle fracture
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	1 / 110 (0.91%)
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
Femoral neck fracture
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	1 / 109 (0.92%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	1 / 109 (0.92%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	1 / 109 (0.92%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	1 / 109 (0.92%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper limb fracture
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 234 (0.00%)	1 / 237 (0.42%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 234 (0.00%)	1 / 237 (0.42%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	0 / 234 (0.00%)	1 / 237 (0.42%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	0 / 234 (0.00%)	2 / 237 (0.84%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Monoparesis
subjects affected / exposed	0 / 234 (0.00%)	1 / 237 (0.42%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular disorder
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	1 / 110 (0.91%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	1 / 110 (0.91%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Inguinal hernia
subjects affected / exposed	1 / 234 (0.43%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	1 / 110 (0.91%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Bone loss
subjects affected / exposed	1 / 234 (0.43%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fracture nonunion
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	1 / 110 (0.91%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	1 / 109 (0.92%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	1 / 110 (0.91%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
COVID-19 pneumonia
subjects affected / exposed	1 / 234 (0.43%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 234 (0.00%)	1 / 237 (0.42%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lyme disease
subjects affected / exposed	1 / 234 (0.43%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	1 / 234 (0.43%)	0 / 237 (0.00%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	0 / 234 (0.00%)	1 / 237 (0.42%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis bacterial
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	1 / 109 (0.92%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	1 / 225 (0.44%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	0 / 225 (0.00%)	1 / 109 (0.92%)	0 / 110 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	Treatment Period I: CT-P47	Treatment Period I: RoActemra	Treatment Period II: CT-P47 Maintenance	Treatment Period II: RoActemra Maintenance	Treatment Period II: Switched to CT-P47
Total subjects affected by non serious adverse events
subjects affected / exposed	139 / 234 (59.40%)	143 / 237 (60.34%)	95 / 225 (42.22%)	54 / 109 (49.54%)	50 / 110 (45.45%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	36 / 234 (15.38%)	49 / 237 (20.68%)	30 / 225 (13.33%)	13 / 109 (11.93%)	15 / 110 (13.64%)
occurrences all number	40	56	36	15	19
Aspartate aminotransferase increased
subjects affected / exposed	12 / 234 (5.13%)	18 / 237 (7.59%)	14 / 225 (6.22%)	8 / 109 (7.34%)	9 / 110 (8.18%)
occurrences all number	14	21	17	9	11
Blood creatine phosphokinase MB increased
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	11 / 225 (4.89%)	7 / 109 (6.42%)	5 / 110 (4.55%)
occurrences all number	0	0	15	9	6
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	7 / 225 (3.11%)	1 / 109 (0.92%)	3 / 110 (2.73%)
occurrences all number	0	0	8	1	4
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	4 / 225 (1.78%)	4 / 109 (3.67%)	1 / 110 (0.91%)
occurrences all number	0	0	5	4	1
Transaminases increased
subjects affected / exposed	6 / 234 (2.56%)	10 / 237 (4.22%)	5 / 225 (2.22%)	1 / 109 (0.92%)	4 / 110 (3.64%)
occurrences all number	8	11	5	1	4
Vascular disorders
Hypertension
subjects affected / exposed	9 / 234 (3.85%)	12 / 237 (5.06%)	2 / 225 (0.89%)	5 / 109 (4.59%)	1 / 110 (0.91%)
occurrences all number	9	12	2	5	1
Nervous system disorders
Headache
subjects affected / exposed	7 / 234 (2.99%)	9 / 237 (3.80%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences all number	9	9	0	0	0
Blood and lymphatic system disorders
Leukopenia
subjects affected / exposed	20 / 234 (8.55%)	25 / 237 (10.55%)	18 / 225 (8.00%)	8 / 109 (7.34%)	12 / 110 (10.91%)
occurrences all number	24	29	26	8	16
Lymphopenia
subjects affected / exposed	9 / 234 (3.85%)	13 / 237 (5.49%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences all number	10	16	0	0	0
Neutropenia
subjects affected / exposed	19 / 234 (8.12%)	23 / 237 (9.70%)	14 / 225 (6.22%)	8 / 109 (7.34%)	12 / 110 (10.91%)
occurrences all number	21	27	18	9	15
Thrombocytopenia
subjects affected / exposed	9 / 234 (3.85%)	8 / 237 (3.38%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences all number	11	9	0	0	0
Immune system disorders
Hypersensitivity
subjects affected / exposed	3 / 234 (1.28%)	8 / 237 (3.38%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences all number	5	9	0	0	0
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	2 / 225 (0.89%)	4 / 109 (3.67%)	3 / 110 (2.73%)
occurrences all number	0	0	2	4	3
Latent tuberculosis
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	16 / 225 (7.11%)	3 / 109 (2.75%)	5 / 110 (4.55%)
occurrences all number	0	0	16	3	5
Nasopharyngitis
subjects affected / exposed	18 / 234 (7.69%)	20 / 237 (8.44%)	8 / 225 (3.56%)	2 / 109 (1.83%)	4 / 110 (3.64%)
occurrences all number	19	23	8	2	4
Oral herpes
subjects affected / exposed	0 / 234 (0.00%)	0 / 237 (0.00%)	4 / 225 (1.78%)	4 / 109 (3.67%)	2 / 110 (1.82%)
occurrences all number	0	0	4	4	2
Pharyngitis
subjects affected / exposed	9 / 234 (3.85%)	4 / 237 (1.69%)	5 / 225 (2.22%)	4 / 109 (3.67%)	4 / 110 (3.64%)
occurrences all number	9	4	5	4	4
Upper respiratory tract infection
subjects affected / exposed	50 / 234 (21.37%)	40 / 237 (16.88%)	16 / 225 (7.11%)	10 / 109 (9.17%)	8 / 110 (7.27%)
occurrences all number	57	48	19	11	10
Metabolism and nutrition disorders
Hypercholesterolaemia
subjects affected / exposed	16 / 234 (6.84%)	19 / 237 (8.02%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences all number	16	20	0	0	0
Hyperlipidaemia
subjects affected / exposed	8 / 234 (3.42%)	5 / 237 (2.11%)	0 / 225 (0.00%)	0 / 109 (0.00%)	0 / 110 (0.00%)
occurrences all number	8	5	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

07 Jul 2022

Summary of significant changes included the following: •Numeric rating scale (NRS) was changed to visual analogue scale (VAS) •Added low-density lipoprotein cholesterol in the laboratory testing •Other editorial changes.

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:
A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 12 - ITT set

Primary: Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 12 - ITT set

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 24 - ITT set

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 24 - ITT set

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 32 - ITT - Treatment Period II subset

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 32 - ITT - Treatment Period II subset

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 52 - ITT - Treatment Period II subset

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 52 - ITT - Treatment Period II subset

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 12 - ITT set

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 12 - ITT set

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 24 - ITT set

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 24 - ITT set

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 32 - ITT - Treatment Period II subset

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 32 - ITT - Treatment Period II subset

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 52 - ITT - Treatment Period II subset

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 52 - ITT - Treatment Period II subset

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 12 - ITT set

Primary: Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 12 - ITT set

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 24 - ITT set

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 24 - ITT set

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 32 - ITT - Treatment Period II subset

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 32 - ITT - Treatment Period II subset

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 52 - ITT - Treatment Period II subset

Secondary: Mean Change From Baseline in DAS28 (ESR) at Week 52 - ITT - Treatment Period II subset

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 12 - ITT set

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 12 - ITT set

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 24 - ITT set

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 24 - ITT set

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 32 - ITT - Treatment Period II subset

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 32 - ITT - Treatment Period II subset

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 52 - ITT - Treatment Period II subset

Secondary: ACR20, ACR50, and ACR70 Response Rate at Week 52 - ITT - Treatment Period II subset

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis