N/A
Completed N=53
Novel MRI ANd Biomarkers in GOlimumab-treated Patients With Axial Spondyloarthritis
Source: ClinicalTrials.gov NCT02011386 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50) — 31 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fulfillment of Bath Ankylosing Spondylitis Disease Activity Index 50 Response (BASDAI50) |
31 | — |
| SECONDARY BASDAI 50% or 2.0 Improvement |
36 | — |
| SECONDARY Ankylosing Spondylitis Disease Activity Score Clinically Important Improvement (ASDAS-CII) |
34 | — |
| SECONDARY MRI Spine Remission |
32 | — |
| SECONDARY MRI-SPINE-50 |
30 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02011386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.