Clinical Trial Results:
Multicenter, open label study to evaluate the predictability of early response to certolizumab pegol (in combination with methotrexate) as confirmed at week 52 in subjects with moderate-severe rheumatoid arthritis (RA)
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Summary
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EudraCT number |
2011-000385-35 |
Trial protocol |
IT |
Global end of trial date |
12 May 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Feb 2016
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First version publication date |
05 Feb 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
RA0069
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01443364 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UCB Pharma S.p.a.
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Sponsor organisation address |
Via Gadames 57, Milano, Italy, 20151
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Public contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.com
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Scientific contact |
Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Jul 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
12 May 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To detect the time-point of clinical response with the highest predictive value of long term efficacy (at Week 52).
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Protection of trial subjects |
Not applicable
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Background therapy |
Not applicable | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
05 Dec 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 132
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Worldwide total number of subjects |
132
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EEA total number of subjects |
132
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
94
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From 65 to 84 years |
38
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85 years and over |
0
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Recruitment
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Recruitment details |
This study started to enroll patients in December 2011 and concluded in May 2015. | ||||||||||||||||||||||
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Pre-assignment
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Screening details |
Participant Flow refers to all subjects randomized who have received at least one dose of study medication. | ||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||
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Arms
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Arm title
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Certolizumab pegol | ||||||||||||||||||||||
Arm description |
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50. | ||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||
Investigational medicinal product name |
Certolizumab pegol
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Investigational medicinal product code |
Cimzia
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Other name |
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Pharmaceutical forms |
Solution for infusion in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Pre-filled syringe with 1 ml of liquid at CZP dosage of 200 mg/ml
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Baseline characteristics reporting groups
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Reporting group title |
Certolizumab pegol
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Reporting group description |
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Certolizumab pegol
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Reporting group description |
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50. | ||
Subject analysis set title |
Certolizumab pegol (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
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End point title |
The percentage of subjects with clinical response at Week 12 who also had clinical response at Week 52 [1] | ||||||||||
End point description |
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
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End point type |
Primary
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End point timeframe |
From Baseline to Week 12 and Week 52
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| 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: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
The percentage of subjects with clinical response at Week 8 who also had clinical response at Week 52 [2] | ||||||||||
End point description |
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
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End point type |
Primary
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End point timeframe |
From Baseline to Week 8 and Week 52
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| 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: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
The percentage of subjects with clinical response at Week 6 who also had clinical response at Week 52 [3] | ||||||||||
End point description |
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
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End point type |
Primary
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End point timeframe |
From Baseline to Week 6 and Week 52
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| 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: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
The percentage of subjects with clinical response at Week 4 who also had clinical response at Week 52 [4] | ||||||||||
End point description |
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
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End point type |
Primary
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End point timeframe |
From Baseline to Week 4 and Week 52
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| 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: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
The percentage of subjects with clinical response at Week 2 who also had clinical response at Week 52 [5] | ||||||||||
End point description |
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
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End point type |
Primary
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End point timeframe |
From Baseline to Week 2 and Week 52
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| 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: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
The percentage of subjects with clinical response at Week 1 who also had clinical response at Week 52 [6] | ||||||||||
End point description |
Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
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End point type |
Primary
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End point timeframe |
From Baseline to Week 1 and Week 52
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| 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: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the synovial fluid and proliferation at Week 52 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 52
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the synovial fluid and proliferation at Week 36 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 36
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the synovial fluid and proliferation at Week 24 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 24
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the synovial fluid and proliferation at Week 12 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 12
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the synovial fluid and proliferation at Week 8 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 8
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the synovial fluid and proliferation at Week 6 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 6
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the synovial fluid and proliferation at Week 4 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 4
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the synovial fluid and proliferation at Week 2 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 2
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the synovial fluid and proliferation at Week 1 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 1
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Doppler signal and blood flow at Week 52 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 52
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Doppler signal and blood flow at Week 36 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 36
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Doppler signal and blood flow at Week 24 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 24
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Doppler signal and blood flow at Week 12 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 12
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Doppler signal and blood flow at Week 8 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 8
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Doppler signal and blood flow at Week 6 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 6
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Doppler signal and blood flow at Week 4 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 4
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Doppler signal and blood flow at Week 2 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 2
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Doppler signal and blood flow at Week 1 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 1
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Cartilage damage at Week 52 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 52
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Cartilage damage at Week 36 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 36
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Cartilage damage at Week 24 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 24
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Cartilage damage at Week 12 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 12
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Cartilage damage at Week 8 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 8
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Cartilage damage at Week 6 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 6
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Cartilage damage at Week 4 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 4
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Cartilage damage at Week 2 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 2
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the Cartilage damage at Week 1 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
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End point type |
Secondary
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End point timeframe |
From Baseline to Week 1
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| No statistical analyses for this end point | |||||||||||
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End point title |
Change from Baseline in the bone erosion at Week 52 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 52
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the bone erosion at Week 36 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 36
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the bone erosion at Week 24 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 24
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the bone erosion at Week 12 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 12
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the bone erosion at Week 8 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 8
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the bone erosion at Week 6 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 6
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the bone erosion at Week 4 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 4
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the bone erosion at Week 2 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 2
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the bone erosion at Week 1 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 1
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 52
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 36
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 24
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 12
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 8
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 6
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 4
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 2
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 1
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 52 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 52
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 36 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 36
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 24 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 24
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 12 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 12
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 8 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 8
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 6 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 6
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 4 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 4
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 2 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 2
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 1 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
From Baseline to Week 1
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Synovial fluid and proliferation at Week 52 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 52
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Synovial fluid and proliferation at Week 36 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 36
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Synovial fluid and proliferation at Week 24 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 24
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Synovial fluid and proliferation at Week 12 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 12
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Synovial fluid and proliferation at Week 8 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 8
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Synovial fluid and proliferation at Week 6 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 6
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Synovial fluid and proliferation at Week 4 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 4
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Synovial fluid and proliferation at Week 2 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 2
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Synovial fluid and proliferation at Week 1 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 1
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Synovial fluid and proliferation at Week 0 | ||||||||||
End point description |
The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 0 (Baseline)
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Doppler signal and blood flow at Week 52 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 52
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Doppler signal and blood flow at Week 36 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 36
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Doppler signal and blood flow at Week 24 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 24
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Doppler signal and blood flow at Week 12 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 12
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Doppler signal and blood flow at Week 8 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 8
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Doppler signal and blood flow at Week 6 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 6
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Doppler signal and blood flow at Week 4 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 4
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Doppler signal and blood flow at Week 2 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 2
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Doppler signal and blood flow at Week 1 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 1
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Doppler signal and blood flow at Week 0 | ||||||||||
End point description |
The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 0 (Baseline)
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Cartilage damage at Week 52 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 52
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Cartilage damage at Week 36 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 36
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Cartilage damage at Week 24 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 24
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Cartilage damage at Week 12 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 12
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Cartilage damage at Week 8 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 8
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Cartilage damage at Week 6 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 6
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Cartilage damage at Week 4 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 4
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Cartilage damage at Week 2 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 2
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Cartilage damage at Week 1 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 1
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Cartilage damage at Week 0 | ||||||||||
End point description |
The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 0 (Baseline)
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Bone erosion at Week 52 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 52
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Bone erosion at Week 36 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 36
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Bone erosion at Week 24 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 24
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Bone erosion at Week 12 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 12
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Bone erosion at Week 8 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 8
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Bone erosion at Week 6 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 6
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Bone erosion at Week 4 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 4
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Bone erosion at Week 2 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 2
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Bone erosion at Week 1 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 1
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Bone erosion at Week 0 | ||||||||||
End point description |
The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 0 (Baseline)
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 52
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 36
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 24
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 12
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 8
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 6
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 4
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 2
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 1
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0 | ||||||||||
End point description |
The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 0 (Baseline)
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 52 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 52
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 36 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 36
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 24 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 24
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 12 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 12
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 8 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 8
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 6 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 6
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 4 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 4
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 2 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 2
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 1 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 1
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||
End point title |
Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 0 | ||||||||||
End point description |
The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
|
||||||||||
End point type |
Secondary
|
||||||||||
End point timeframe |
Week 0 (Baseline)
|
||||||||||
|
|||||||||||
| No statistical analyses for this end point | |||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Certolizumab pegol
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
07 Jul 2011 |
Protocol Amendment 1, dated 07 Jul 2011, was implemented after the central ethics committee review of the initial protocol, when changes were deemed necessary for conduct of this study in Italy. This amendment occurred prior to inclusion of subjects.
The following changes were made throughout the protocol:
• Quality of Life assessments were altered (eg, removal of PRISM test, Euro QoL-5D changed to EQ-5D-3L).
• Evaluation of healthcare use’ was added as an exploratory objective (and accordingly was added in list of other efficacy variables and concomitant procedures).
• Laboratory assessments were centralized, except for ESR, TB and urine pregnancy testing. |
||
07 Jul 2011 |
• Safety reporting was updated, with extension of the follow up period from 30 days to 10 weeks, and clarification that a serious AE (SAE) or an AE leading to premature discontinuation from the study had to be followed up until it had resolved, stabilized or the Investigator no longer felt it was clinically significant; TB and ischemic cardiac events were added to AEs of interest list; the anticipated AE list was removed.
• Biomarkers assessments were updated (Week 0 assessment changed to Week -2).
• Immunological assessments were updated (Week -2 assessment deleted, and Weeks 0, 2, 6, 12, and 36 assessments added to text).
• For pregnancy testing and x-ray assessment, previously missing text was added (to correspond with schedule).
• An explanation was added that EQ-5D-3L dimensions scores, VAS actual scores, and healthcare resource utilization scores would be summarized using descriptive statistics.
• Previously termed ‘anticipated AEs’ in Appendices were renamed ‘predicted AEs,’ and those for CZP added.
• Inclusion criterion number 9 was changed from ‘Subject is naïve or has received up to 1 prior anti-TNF therapy, which was not discontinued due to primary failure’ to ‘Subject is naïve to RA related biologics (eg, anti-TNF therapy).
• Exclusion criteria numbers 13 to 17 regarding prior treatments were replaced with ‘Subject has received previous RA related biologics therapy (eg, anti-TNF)’. |
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24 Oct 2011 |
Protocol Amendment 2, dated 24 Oct 2011, was implemented after the Sponsor discussed the subgroup analysis with other experts. It was decided to remove the MRI assessments: although the use of gadolinium would have resulted in better data, this invasive method could have been a limiting factor and restrict recruitment. Lack of interest in MRI assessments at investigational sites also contributed to this decision. It was agreed that remaining methods would still provide sufficient data to monitor the response of joint synovitis and to investigate the predictability of an early sonography response for long-term response. The MRI Assessment was therefore removed from all applicable sections.
In addition, clarification was added that methotrexate should be taken throughout the study without discontinuation, and that no dose adjustment was allowed except for documented intolerance or toxicity.
This amendment was approved after one subject had been screened. |
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06 Mar 2013 |
Protocol Amendment 3, dated 06 Mar 2013, was implemented after to clarify objectives and endpoints of the study, to add a second reading of US images for the purpose of assessing interreader variability, to align the protocol with UCB standards in terms of definitions, naming conventions, and procedures, and to streamline the planned data analysis in alignment with the objectives.
Specifically:
• The secondary objective was modified to allow for more general conclusions on the results of US assessments; assessment of the changes in CRP and ESR were replaced with assessment of the relationship between US response and clinical response over time.
• Endpoints were shifted in the appropriate sections in alignment with the objectives; in particular, CRP and ESR were moved to the Other Efficacy section.
• The procedure of the analysis of US images was amended to allow for an assessment of interobserver reliability.
• Clarifications and definitions were added to specify the study conduct and procedures. |
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06 Mar 2013 |
• Definitions were updated to be consistent with UCB standards (eg, specifications of tuberculosis [TB] assessments and the TEAE definition).
• Study timelines were amended according to new forecasts.
• Rescreening of subjects was allowed for screen-failed subjects.
The following additional changes were made throughout the protocol:
• The upper limit of the category Low Disease Activity was changed from <3.2 to ≤3.2.
• The definition of clinical response based on DAS28-ESR was changed from a reduction of >1.2 scores in the DAS28-ESR to a reduction of ≥1.2 scores in the DAS28-ESR.
• The Health assessment questionnaire (HAQ) was renamed Health Assessment Questionnaire Disability Index (HAQ-DI).
• The term Investigator’s Assessment of Disease Activity (IGA) was changed to Physician’s Assessment of Disease Activity (PhGADA).
• The abbreviation of Patient’s Assessment of Disease Activity (PGA) was changed to PtGADA.
• The word parameter was replaced by the word variable.
• HBV DNA requirements were clarified. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
