Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
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Purpose
The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Golimumab Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy |
- American College of Rheumatology (ACR) 20 response [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
- Disease Activity Index Score (DAS 28) Response [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
- American College of Rheumatology 20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- HAQ (Disability Index of the Health Assessment Questionnaire) score change from baseline [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
| Enrollment: | 264 |
| Study Start Date: | August 2010 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 001
Golimumab 50 mg subcutaneous (SC) injection every 4 weeks for 48 weeks
|
Drug: Golimumab
50 mg subcutaneous (SC) injection every 4 weeks for 48 weeks
|
|
Experimental: 002
Placebo Placebo SC injections at Weeks 0 4 8 12 16 and Week 20 followed by golimumab with early escape at Week 16. 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48. |
Drug: Placebo
Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab with early escape at Week 16. 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48. |
Detailed Description:
Golimumab is a type of tumor necrosis factor (TNF)-inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease by blocking the activity of TNF in the body and reducing inflammation and pain. Each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. Patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). The chance that the patient will get golimumab is 1 to 1, a 50% chance to receive golimumab and a 50% chance to receive placebo. If the patient does not have an improvement in their joints at the Week 16 visit compared to when they entered the study, and are in Group 1 (placebo group), the patient will receive golimumab 50 mg every 4 weeks starting at Week 16. If the patient is in Group 2 (golimumab 50 mg), the patient will continue to receive golimumab every 4 weeks starting at Week 16. If the patient is in Group 1 and is still receiving placebo injections, because there was improvement in their joints at Week 16, the patient will receive golimumab 50 mg every 4 weeks starting from Week 24. If the patient is in Group 2 (golimumab 50 mg) or is already receiving golimumab injections at week 24, the patient will continue to receive golimumab every 4 weeks. Safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (e.g., blood pressure), and the frequency and type of adverse events (side effects). The patient will be in the study approximately 56 weeks. Patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks from randomization (Week 0) until Week 48.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China | |
| Beijing, China | |
| Chengdu, China | |
| Hefei, China | |
| Jinan, China | |
| Nanjing, China | |
| Shanghai, China | |
| Suzhou, China | |
| Wuhan, China | |
| Xi'An, China | |
| Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
More Information
No publications provided
| Responsible Party: | Centocor, Inc. |
| ClinicalTrials.gov Identifier: | NCT01248780 History of Changes |
| Other Study ID Numbers: | CR015913, C0524T28 |
| Study First Received: | November 24, 2010 |
| Last Updated: | September 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Centocor, Inc.:
|
Rheumatoid Arthritis injection golimumab simponi |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013