Phase 3
Completed N=264
Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Source: ClinicalTrials.gov NCT01248780 ↗Enrolled (actual)
264
Serious AEs
4.6%
Results posted
Jul 2013
Primary outcomePrimary: American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14 — 21; 54 Number of participants — p=<0.001
Summary
The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American College of Rheumatology (ACR) 20 Response, Using CRP (C-reactive Protein), at Week 14 |
21; 54 | <0.001 sig |
| SECONDARY Disease Activity Index Score (DAS 28) Response, Using CRP (C-reactive Protein) |
40; 86 | <0.001 sig |
| SECONDARY American College of Rheumatology 20 Response, Using CRP, at Week 24 |
21; 56 | <0.001 sig |
| SECONDARY HAQ (Disability Index of the Health Assessment Questionnaire) Score Change From Baseline |
0.1525; -0.2623 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of rheumatoid arthritis for at least 6 months
- Be on a stable dose of methotrexate for 4 weeks
- Have at least 4 swollen and 4 tender joints
Exclusion Criteria
- Prior exposure to biologic anti-TNFalpha agents
- Inflammatory diseases other than rheumatoid arthritis
- Treatment with Disease Modifying Anti-rheumatic drug (DMARDs)/systemic immunosuppressives other than methotrexate during the 4 weeks prior to the first administration of study agent
- History of, or ongoing, chronic or recurrent infectious disease
Data sourced from ClinicalTrials.gov (NCT01248780). 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.