A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
This study has been completed.
Sponsor:
Janssen Pharmaceutical K.K.
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00727987
First received: July 31, 2008
Last updated: May 22, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: CNTO 148 Drug: Placebo Drug: Methotrexate (MTX) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis |
Resource links provided by NLM:
Further study details as provided by Janssen Pharmaceutical K.K.:
Primary Outcome Measures:
- ACR 20% response [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- ACR 50% response, ACR 70% response, ACR 90% response, Changes from the pretreatment values in the DAS (Disease Activity Score) 28, and the HAQ (Health assessment questionnaire) [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
| Enrollment: | 269 |
| Study Start Date: | May 2008 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: CNTO 148 50 mg + methotrexate |
Drug: CNTO 148
50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152.
Other Name: Golimumab
Drug: Methotrexate (MTX)
6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.
|
| Experimental: CNTO 148 100 mg + methotrexate |
Drug: Methotrexate (MTX)
6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.
|
| Placebo Comparator: Placebo + methotrexate |
Drug: Placebo
Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24.
Drug: Methotrexate (MTX)
6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.
|
Detailed Description:
This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152. CNTO148 100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until week 152 whether early escape or not Placebo group: Placebo SC injections every 4 weeks from the first administration until week 20 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 152
Eligibility| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatology (1987)
- Patients in whom MTX therapy (>= 6 mg/week) was started more than 3 months before the first administration and who have been treated with MTX at a stable dose (6-8 mg/week) for at least 4 weeks before the first administration
- Patients having at least 4 swollen joints and at least 4 tender joints at the time of registration and immediately before the first administration.
Exclusion Criteria:
- Patients with a history of hypersensitivity to human immunoglobulin proteins or other ingredients of golimumab
- Patients who have previously experienced or are suffering from any of the following diseases: (i) Collagen diseases other than rheumatoid arthritis, (ii) Latent or active granulomatous infections such as histoplasmosis and coccidioidomycosis, (iii) Felty syndrome, etc
- Patients with a severe, advanced, or poorly controlled disease in any of the kidney, liver, blood, gastrointestinal system, endocrine system, lung, heart, nervous system, psychiatric system, and brain.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727987
Show 69 Study Locations
Show 69 Study LocationsSponsors and Collaborators
Janssen Pharmaceutical K.K.
Mitsubishi Tanabe Pharma Corporation
Investigators
| Study Director: | Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. |
More Information
Additional Information:
No publications provided by Janssen Pharmaceutical K.K.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Janssen Pharmaceutical K.K. |
| ClinicalTrials.gov Identifier: | NCT00727987 History of Changes |
| Other Study ID Numbers: | CR015340, JNS012-JPN-03 |
| Study First Received: | July 31, 2008 |
| Last Updated: | May 22, 2013 |
| Health Authority: | Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center |
Keywords provided by Janssen Pharmaceutical K.K.:
|
Rheumatoid arthritis Fully Human anti-TNFa monoclonal antibody CNTO148 Golimumab |
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 22, 2013