NCT02011386CompletedNot Applicable
Improved Monitoring and Prediction of Clinical Response and Disease Course During Golimumab Therapy of Patients With Axial Spondyloarthritis
Professor Mikkel Østergaard6 sites in 1 country53 target enrollmentStarted: February 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 6
- Primary Endpoint
- Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50)
Study Overview
Brief Summary
The study investigates different criteria for remission based on MRI and circulating biomarkers for inflammation, cartilage, connective tissue and bone turnover in patients with axial spondyloarthritis treated with Golimumab. Furthermore, the study also investigates factors that affect disease activity, function and participation by use of different questionnaires.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Axial spondyloarthritis according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axial spondyloarthritis
- •Sacroiliitis on conventional X-rays or Magnetic Resonance Imaging (MRI).
- •Disease activity assessed by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >40 mm despite treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAID).
- •Clinical indication for tumor necrosis factor (TNF) inhibitor treatment by the treating physician.
Exclusion Criteria
- •No contraindications for TNF inhibitor
- •No contraindications for MRI
- •No contraindications in participation in a study
Arms & Interventions
Treatment
Treatment: Injection Golimumab 50 mg every month on the same date
Intervention: Treatment (Drug)
Outcomes
Primary Outcomes
Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50)
Time Frame: Week 52
At least 50% reduction in BASDAI score at follow-up compared with BASDAI score at baseline
Secondary Outcomes
- BASDAI 50% or 2.0 Improvement(Week 52)
- Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII)(Week 52)
- MRI Spine Remission(Week 16)
- MRI-SPINE-50(Week 16)
Investigators
Professor Mikkel Østergaard
MD, PhD
Rigshospitalet, Denmark
Study Sites (6)
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