Clinical Trial Results:
A Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Active Psoriatic Arthritis Subjects Who Have Completed a Preceding Study M14-197 Phase 2 Randomized Controlled Trial (RCT)
|
Summary
|
|
EudraCT number |
2014-005527-27 |
Trial protocol |
HU CZ DE LV ES IT |
Global end of trial date |
02 Aug 2016
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
11 Jun 2017
|
First version publication date |
11 Jun 2017
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
M14-198
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02429895 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
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, Program Lead, AbbVie, lawrence.mcnamee@abbvie.com
|
||
Scientific contact |
Peloso, Paul, Medical Director, AbbVie, paul.peloso@abbvie.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
02 Aug 2016
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
02 Aug 2016
|
||
Was the trial ended prematurely? |
Yes
|
||
|
General information about the trial
|
|||
Main objective of the trial |
Assess the long term efficacy, and safety and tolerability of ABT-122 in psoriatic arthritis (PsA) subjects on background methotrexate (MTX) who have completed Study M14-197, a Phase 2 randomized controlled trial (RCT).
|
||
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 |
01 Oct 2015
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Poland: 89
|
||
Country: Number of subjects enrolled |
Romania: 1
|
||
Country: Number of subjects enrolled |
Spain: 9
|
||
Country: Number of subjects enrolled |
Bulgaria: 30
|
||
Country: Number of subjects enrolled |
Czech Republic: 6
|
||
Country: Number of subjects enrolled |
Germany: 2
|
||
Country: Number of subjects enrolled |
Hungary: 2
|
||
Country: Number of subjects enrolled |
Latvia: 22
|
||
Country: Number of subjects enrolled |
Australia: 2
|
||
Country: Number of subjects enrolled |
New Zealand: 5
|
||
Worldwide total number of subjects |
168
|
||
EEA total number of subjects |
161
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
151
|
||
From 65 to 84 years |
17
|
||
85 years and over |
0
|
||
|
|||||||||||||||||
|
Recruitment
|
|||||||||||||||||
Recruitment details |
- | ||||||||||||||||
|
Pre-assignment
|
|||||||||||||||||
Screening details |
A total of 168 subjects diagnosed with active RA on background MTX who had participated in the RCT Study M14-197 (2014-003558-15) enrolled in this open-label extension (OLE). | ||||||||||||||||
|
Period 1
|
|||||||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Not applicable
|
||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||
|
Arms
|
|||||||||||||||||
|
Arm title
|
ABT-122 | ||||||||||||||||
Arm description |
Open-label ABT-122 240 mg every other week (EOW) for 24 weeks | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
ABT-122
|
||||||||||||||||
Investigational medicinal product code |
ABT-122
|
||||||||||||||||
Other name |
Remtolumab
|
||||||||||||||||
Pharmaceutical forms |
Powder for solution for injection
|
||||||||||||||||
Routes of administration |
Subcutaneous use
|
||||||||||||||||
Dosage and administration details |
All subjects were treated with ABT-122 240 mg EOW in an open-label fashion with the possibility of an extra 240 mg dose. In order to be considered for the extra dose the subject must have met American College of Rheumatology (ACR) 20 response criteria in the RCT (Study M14-197) or in the OLE (Study M14-198) and afterward lost ACR20 response.
|
||||||||||||||||
|
|||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Overall Study
|
||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
ABT-122
|
||
Reporting group description |
Open-label ABT-122 240 mg every other week (EOW) for 24 weeks | ||
|
|||||||||||||||||
End point title |
ACR20 Response Rate by Visit [1] | ||||||||||||||||
End point description |
Percentage of subjects with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein [hsCRP]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n=subjects who had an assessment at the given time point.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
| 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, along with 95% confidence intervals, are presented per protocol. |
|||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
ACR50 Response Rate by Visit [2] | ||||||||||||||||
End point description |
Percentage of subjects with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n=subjects who had an assessment at the given time point.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
| 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, along with 95% confidence intervals, are presented per protocol. |
|||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
ACR70 Response Rate by Visit [3] | ||||||||||||||||
End point description |
Percentage of subjects with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n=subjects who had an assessment at the given time point.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
| 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, along with 95% confidence intervals, are presented per protocol. |
|||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change from Baseline in Disease Activity Score 28 (DAS28[hsCRP]) by Visit | ||||||||||||||||
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.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n= subjects available at both the given visit and baseline visit.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate per DAS28 (hsCRP) by Visit | ||||||||||||||||
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 to 10, with higher scores indicating more 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 Agresti-Coull method.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n= subjects available at both the given visit and baseline visit.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
CR Response Rate Per DAS28 (hsCRP) by Visit | ||||||||||||||||
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 to 10, with higher scores indicating more disease activity. 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 Agresti-Coull method.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n= subjects available at both the given visit and baseline visit.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 32
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Psoriasis Area and Severity Index (PASI) 50 Response Rate by Visit | ||||||||||||||||
End point description |
Percentage of PASI50 responders, defined as a 50% improvement in PASI score compared to baseline in subjects with ≥ 3% Body Surface Area (BSA) psoriasis involvement at baseline. PASI assesses four anatomic sites (head, upper extremities, trunk, and lower extremities) for erythema, induration and desquamation related to psoriasis. PASI scores range from 0.0 to 72.0 with the highest score representing complete erythroderma of the severest possible degree. Typically, scores of 3 or less represent mild disease, scores over 3 and up and including 15 represent moderate disease, and scores over 15 are considered to be associated with severe disease. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n=subjects who had an assessment at the given time point.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
PASI75 Response Rate by Visit | ||||||||||||||||
End point description |
Percentage of PASI75 responders, defined as a 75% improvement in PASI score compared to baseline in subjects with ≥ 3% BSA psoriasis involvement at baseline. PASI assesses four anatomic sites (head, upper extremities, trunk, and lower extremities) for erythema, induration and desquamation related to psoriasis. PASI scores range from 0.0 to 72.0 with the highest score representing complete erythroderma of the severest possible degree. Typically, scores of 3 or less represent mild disease, scores over 3 and up and including 15 represent moderate disease, and scores over 15 are considered to be associated with severe disease. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n=subjects who had an assessment at the given time point.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
PASI90 Response Rates by Visit | ||||||||||||||||
End point description |
Percentage of PASI90 responders, defined as a 90% improvement in PASI score compared to baseline in subjects with ≥ 3% BSA psoriasis involvement at baseline. PASI assesses four anatomic sites (head, upper extremities, trunk, and lower extremities) for erythema, induration and desquamation related to psoriasis. PASI scores range from 0.0 to 72.0 with the highest score representing complete erythroderma of the severest possible degree. Typically, scores of 3 or less represent mild disease, scores over 3 and up and including 15 represent moderate disease, and scores over 15 are considered to be associated with severe disease. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n=subjects who had an assessment at the given time point.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Minimal Disease Activity (MDA) in PsA Response Rate by Visit in Subjects with PASI > 3 at Baseline | ||||||||||||||||
End point description |
A subject was classified as in MDA when 5 of the following 7 criteria are met: Tender Joint Count 68 ≤ 1; Swollen Joint Count 66 ≤ 1; PASI ≤ 1 or BSA ≤ 3; Patient Assessment of Pain ≤ 15; Patient Global Assessment ≤ 20; Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) ≤ 0.5; tender entheseal points ≤ 1. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n=subjects who had an assessment at the given time point.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Week 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Physician's Global Assessment for Psoriasis Score of 0 or 1 Response Rate by Visit | ||||||||||||||||
End point description |
The physician assessed the severity of a subject's disease activity at the time of visit using a Physician's Global Assessment of Psoriasis 7-point scale. The scale ranges from 0 to 6. A higher score indicates more severe psoriasis activity, with 0 corresponding to "clear" and 6 corresponding to "severe." Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.
Safety Analysis Set: subjects who received ≥ 1 dose of study drug in Study M14-198; n=subjects who had an assessment at the given time point.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change From Baseline in Psoriasis Target Lesion Score by Visit | ||||||||||||||||
End point description |
Target lesion score for psoriasis in subjects with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque scaling and thickness) to 15 (severe erythema and evidence of plaque scaling and thickness).
Safety Analysis Set: all subjects who received ≥ 1 dose of study medication in Study M14-198; n=subjects available at both the specific visit and baseline visit.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change From Baseline in Physician's Global Assessment for Psoriasis by Visit | ||||||||||||||||
End point description |
The physician assessed the severity of a subject's disease activity at the time of visit using a Physician's Global Assessment of Psoriasis 7-point scale. The scale ranges from 0 to 6. A higher score indicates more severe psoriasis activity, with 0 corresponding to "clear" and 6 corresponding to "severe."
Safety Analysis Set: all subjects who received ≥ 1 dose of study medication in Study M14-198; n=subjects available at both the specific visit and baseline visit.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change From Baseline in PASI by Visit | ||||||||||||||||
End point description |
PASI assesses four anatomic sites (head, upper extremities, trunk, and lower extremities) for erythema, induration and desquamation related to psoriasis. PASI scores range from 0.0 to 72.0 with the highest score representing complete erythroderma of the severest possible degree. Typically, scores of 3 or less represent mild disease, scores over 3 and up and including 15 represent moderate disease, and scores over 15 are considered to be associated with severe disease.
Safety Analysis Set: all subjects who received ≥ 1 dose of study medication in Study M14-198; n=subjects available at both the specific visit and baseline visit.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change From Baseline in Dactylitis by Visit | ||||||||||||||||
End point description |
The dactylitis count was calculated as the number of digits (hands and feet) with presence of dactylitis. The count ranges from 0 to 20, with higher scores indicating more severe dactylitis.
Safety Analysis Set: all subjects who received ≥ 1 dose of study medication in Study M14-198; n=subjects available at both the specific visit and baseline visit.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis by Visit | ||||||||||||||||
End point description |
The SPARCC enthesitis index is an outcome measure for enthesitis in spondyloarthritis. Tenderness at each of 16 site is quantified on a dichotomous basis: 0 means non-tender and 1 means tender. The SPARCC enthesitis index is calculated by taking the sum of the scores from the 16 sites. The SPARCC score ranges from 0 to 16, with higher scores indicating more tenderness.
Safety Analysis Set: all subjects who received ≥ 1 dose of study medication in Study M14-198; n=subjects available at both the specific visit and baseline visit.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Weeks 4, 8, 16, 24
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug in study M14-198 until 70 days after the last dose of study drug (up to 32 weeks).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
A protocol-related event is defined as any AE with onset or worsening reported by a subject from the first dose of study drug in study M14-198 until 70 days have elapsed following discontinuation of ABT-122 administration. Events were collected whether elicited or spontaneously reported by the subject.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
ABT-122
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Open-label ABT-122 240 mg EOW for 24 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
06 Aug 2015 |
The purpose of this amendment was to:
● Extend enrollment to a maximum of 220 subjects to allow all eligible subjects to have the option to participate.
● Increase the number of participating sites for consistency with the number of sites in the RCT.
● Revise wording for the approved birth control methods to ensure that only highly effective contraceptive measures were allowed, consistent with the recommendations related to contraception and pregnancy testing in clinical trials by the European Union Clinical Trial Facilitation Group (Heads of Medicines Agencies).
● Clarify the visits that had a 3-day visit window.
● Add electrocardiogram (ECG) at Week 0 and optional ECG at Week 24 to study procedures.
● Add assessment instructions in the event of an injection site reaction.
● Correct test names and clarification of microscopic urinalysis testing.
● Update study procedures to include Patient Global Disease Activity for Arthritis visual analog scale Patient's Global Assessment of Disease Activity (PtGA) assessments at the Week 4, 8, 16, 24/Premature Discontinuation visits.
● Remove 24 hour Methylhistamine assay deleted from hypersensitivity reaction panel.
● Add criteria for extra dose eligibility.
● Update of primary study contact.
● Add detail to comparison point for ACR 20/50/70 response assessment.
● Add details regarding the use of ePro devices for data collection.
● Apply administrative changes throughout the protocol.
|
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
