A Study of Safety and Effectiveness of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
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Purpose
The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with and without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Biological: Golimumab Biological: Methotrexate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy |
- Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 [ Time Frame: Week 0 to Week 14 ] [ Designated as safety issue: No ]An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).
- Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24 [ Time Frame: Week 0 to Week 24 ] [ Designated as safety issue: No ]ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).
- Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 [ Time Frame: Week 0 to Week 14 ] [ Designated as safety issue: No ]ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity [based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities] and CRP blood test to measure inflammation).
- Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14 [ Time Frame: Week 0 to Week 14 ] [ Designated as safety issue: No ]The DAS28 using CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and Patient's Global Assessment of Disease Activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.
- Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14 [ Time Frame: Weeks 0 to Week 14 ] [ Designated as safety issue: No ]The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.
| Enrollment: | 643 |
| Study Start Date: | August 2006 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group I
2 mg per kg golimumab intravenous (IV) infusion every 12 weeks with active methotraxate (MTX) at the same dose as that before study entry through Week 48
|
Biological: Golimumab
An appropriate dose of golimumab liquid in vial will be diluted in 100 mL 0.9% sodium chloride solution and administered over 30 minutes
Biological: Methotrexate
Active MTX capsules are filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet
|
|
Placebo Comparator: Group II
2 mg per kg golimumab IV infusion every 12 weeks with placebo (sham MTX) capsules through Week 48
|
Biological: Golimumab
An appropriate dose of golimumab liquid in vial will be diluted in 100 mL 0.9% sodium chloride solution and administered over 30 minutes
|
|
Experimental: Group III
4 mg per kg golimumab IV infusion every 12 weeks with active MTX at the same dose as that before study entry through Week 48
|
Biological: Golimumab
An appropriate dose of golimumab liquid in vial will be diluted in 100 mL 0.9% sodium chloride solution and administered over 30 minutes
Biological: Methotrexate
Active MTX capsules are filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet
|
|
Placebo Comparator: Group IV
4 mg per kg golimumab IV infusion every 12 weeks with placebo (sham MTX) capsules through Week 48
|
Biological: Golimumab
An appropriate dose of golimumab liquid in vial will be diluted in 100 mL 0.9% sodium chloride solution and administered over 30 minutes
|
|
Placebo Comparator: Group V
Placebo IV infusions every 12 weeks with active MTX at the same dose as that before study entry through Week 48
|
Biological: Methotrexate
Active MTX capsules are filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet
|
Detailed Description:
This is a Phase III, double blind (neither investigator nor the patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), multicenter, 5-arm (treatment groups) study of golimumab at 2 doses (given with or without MTX over a period of 30 minutes) for at least 48 weeks in patients with active RA despite concurrent MTX therapy. The study consists of a treatment period of golimumab IV infusions for enrolled patients which ranges from 48 weeks to approximately 140 weeks, assuming an enrollment period of approximately 92 weeks and a long-term extension period, in which golimumab subcutaneous (SC) injections will be given for 24 weeks. The end of study will be the time the last patient completes the Week E-40 visit for safety follow-up assessments. The patients will be randomly assigned to 1 of the 5 treatment groups in a 1:1:1:1:1 ratio (approximately 125 patients per group). Safety will be monitored throughout the study. The entire study duration for each patient will range from 88 weeks up to 192 weeks, assuming an enrollment period of approximately 92 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender joints for at least 3 months prior to screening - Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
Exclusion Criteria:
- Patients having known hypersensitivity (severe allergy) to human immunoglobulin proteins or other components of golimumab - Having known clinically serious adverse reaction to a biologic anti-TNF agent - Have had history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening
Contacts and Locations
Show 72 Study Locations| Study Director: | Centocor, Inc. Clinical Trial | Centocor, Inc. |
More Information
No publications provided by Centocor, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Centocor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00361335 History of Changes |
| Other Study ID Numbers: | CR012781, C0524T12, 2005-003232-21 |
| Study First Received: | August 4, 2006 |
| Results First Received: | February 24, 2010 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Centocor, Inc.:
|
Rheumatoid arthritis Golimumab Methotrexate Tumor Necrosis Factor-alpha Immunology |
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