Study of Adalimumab in Patients With Axial Spondyloarthritis
Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.
Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response
Time Frame: Baseline and Week 12
Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response
Time Frame: Baseline and Week 12
Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
Time Frame: Baseline and Week 12
Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score
Time Frame: Baseline and Week 12
Number of Participants Achieving ASAS Partial Remission
Time Frame: Week 12
Number of Participants Achieving an ASAS5/6 Response
Time Frame: Baseline and Week 12
Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S)
Time Frame: Baseline and Week 12
Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time Frame: Baseline and Week 12
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints
Time Frame: Baseline and Week 12
Change From Baseline in SPARCC MRI Score for the Spine
Time Frame: Baseline and Week 12
Interventions:
- Biological: Adalimumab
- Biological: Placebo
- Biological: Open-label Adalimumab
Enrollment:
192
Available Documents
FaFilePdfScientific Result Summary (English)Additional Information
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