Phase 3
Completed N=213
Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT01248793 ↗Enrolled (actual)
213
Serious AEs
2.8%
Results posted
Jun 2012
Primary outcomePrimary: Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14 — 26; 53 Participants
Summary
The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14 |
26; 53 | — |
| SECONDARY Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24 |
24; 54 | — |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14 |
0.113; -1.262 | — |
| SECONDARY Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14 |
-0.19; -0.42 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of definite akylosing spondylitis for at least 3 months
- Have symptoms of active disease at screening and at baseline
- no active infections
Exclusion Criteria
- Have other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy
- Have complete ankylosis of the spine
- Have a history of latent or active granulomatous infection
- Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent.
Data sourced from ClinicalTrials.gov (NCT01248793). 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.