Phase 3
Completed N=356
A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis
Spondylitis, Ankylosing
Source: ClinicalTrials.gov NCT00265083 ↗
Enrolled (actual)
356
Serious AEs
20.4%
Results posted
Jul 2009
Primary outcomePrimary: Assessment in Ankylosing Spondylitis 20 Responders at Week 14 — 17; 82; 84; 166 Participants — p=<0.001
Summary
The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis [AS(arthritis of the spine)]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment in Ankylosing Spondylitis 20 Responders at Week 14 |
17; 82; 84; 166 | <0.001 sig |
| SECONDARY Assessment in Ankylosing Spondylitis 20 Responders at Week 24 |
18; 77; 92; 169 | <0.001 sig |
| SECONDARY Summary of Change From Baseline in Bath Ankylosing Spondylitis Functional Index at Week 14 |
0.095; -1.375; -1.495; -1.420 | <0.001 sig |
| SECONDARY Summary of Change From Baseline in Bath Ankylosing Spondylitis Metrology Index at Week 14 |
-0.28; -0.36; -0.49; -0.43 | 0.288 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New York criteria, for at least 3 months prior to first dose of study drug
- Symptoms of active disease at screening and at baseline visits, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of >= 4, and a Total Back Pain score of >= 4 (each on a scale of 0 to 10cm)
- Inadequate response to 3 months of continuous therapy with maximal recommended doses of NSAIDs, or else unable to receive a full 3 months of maximal NSAID therapy because of intolerance, toxicity, or contraindications to non-steroidal anti-inflammatory drugs (NSAIDs)
- Stable doses of methotrexate, sulfasalazine, hydroxychloroquine, low-dose corticosteroids, and NSAIDs are permitted.
Exclusion Criteria
- Patients cannot have complete ankylosis of the spine
- No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)
Data sourced from ClinicalTrials.gov (NCT00265083). 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.