None listed
Conditions
Brief summary
BG00012 has been shown to be effective in reducing signs and symptoms of psoriasis and multiple sclerosis. BG00012 may be effective in the treatment of rheumatoid arthritis (RA) as well. The present study will test this concept in subjects with RA who have not responded adequately to methotrexate (MTX), the standard first-line oral agent for this disease.
Interventions
Intervention (All groups)
Methotrexate as a stabilised treatment regimen between greater than or equal to 7.5mg per week to less than or equal to 25mg per week, as prescribed by their rheumatologist or general care physician. Dosage form either oral or injectable but cannot change through week 12. The dosage may be decreased if required due to toxicity.
Intervention Group 1
BG00012 240 mg twice daily orally and placebo once daily orally for 12 weeks
Intervention Group 2
BG00012 240 mg 3 times
Intervention (All groups) Methotrexate as a stabilised treatment regimen between greater than or equal to 7.5mg per week to less than or equal to 25mg per week, as prescribed by their rheumatologist or general care physician. Dosage form either oral or injectable but cannot change through week 12. The dosage may be decreased if required due to toxicity. Intervention Group 1 BG00012 240 mg twice daily orally and placebo once daily orally for 12 weeks Intervention Group 2 BG00012 240 mg 3 times daily orally for 12 weeks
Sponsors
Biogen Idec, Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Written informed consent - Diagnosis of adult onset RA according to the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis (Functional Class I – III)(Section22, Appendix A) for at least 6 months prior to Day 0. - Must have been treated with, and be tolerating, methotrexate for at least 3 months immediately prior to Day 0. The dose of mthotrexate must be stable for at least 4 weeks prior to Day 0. - All subjects of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment.
Exclusion criteria
Medical History 1. Subjects with a history of malignant disease, including solid tumors and haematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured). 2. History of severe allergic or anaphylactic reactions or known drug hypersensitivity. 3. History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal or hematologic insufficiency, or any major disease that could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., Parkinson’s disease, cerebral palsy, diabetic neuropathy). 4. Known active bacterial, viral, fungal, mycobacterial, opportunistic infection or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of Day 0. 5. Nursing mothers, pregnant women, or women who are planning to become pregnant while in the study. Treatment History 6. Other clinical issues or laboratory results that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
Outcome results
None listed