The primary purpose of this study is to assess the clinical effectiveness and safety of intravenous (IV- injection directly into the vein) golimumab infusions every 12 weeks in patients with active rheumatoid arthritis (RA) despite current MTX treatment. The secondary objectives of this study are to evaluate the effects on physical function, quality of life, and the pharmacological features of golimumab in subjects with active RA.
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
Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary Outcome Measures:
- A comparison of the proportion of patients who achieve an ACR 50 response at Week 14 between subjects receiving golimumab and those receiving placebo.
Secondary Outcome Measures:
- The proportion of patients who achieve an ACR 50 response at Week 24
- The proportion of patients who achieve an ACR 20 response at Week 14
- The proportion of patients with moderate or good response in DAS28 using CRP at Week 14.
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
- Have a diagnosis of active RA (according to the revised 1987 criteria of the ARA(American Rheumatism Association)
- Arnett et al, 1988) with at least 4 swollen and 4 tender joints for at least 3 months prior to screening
- Have been treated with and tolerated MTX at a dose of at least 15 mg/week for at least 3 months prior to screening, and have been on a stable MTX dose of >=15 mg/week and <= 25 mg/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
- If using oral corticosteroids, must be on a stable dose equivalent to <=10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent. If currently not using corticosteroids, the subject must have not received oral corticosteroids for at least 2 weeks prior to first administration of study agent
- Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination and chest x-ray
- No known hypersensitivity (severe allergy) to human immunoglobulin proteins or other components of golimumab
- No known clinically serious adverse reaction to a biologic anti-TNF agent
- No known history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening
- No current signs or symptoms of severe, progressive, or uncontrolled kidney, liver, blood, gastrointestinal, glandular, lung, heart, nervous system, psychiatric, or brain disease
- No history of, or concurrent, congestive heart failure (CHF), including medically controlled, asymptomatic CHF
- No known cancer or history of cancer within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence)
- Perth, 6979, Australia; Recruiting
- Woodville, 5011, Australia; Recruiting
- Fitzroy, 3065, Australia; Not yet recruiting
- Maroochydore, 4558, Australia; Recruiting
- Heidleberg, 3084, Australia; Not yet recruiting
- Melbourne, 3144, Australia; Recruiting
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