a dose range finding study of jnj-39758979 in patients with active rheumatoid arthritis currently treated with methotrexate

Conditions: Active Rheumatoid Arthritis; Rheumatoid Arthritis

Summary: the purpose of the study is to assess the efficacy, safety and tolerability of jnj-39758979 at doses of 10, 30, 100, and 300 mg/day compared with placebo (inactive medical substance) in patients with active rheumatoid arthritis despite concomitant treatment with methotrexate (mtx).

this is a double-blind (neither physician nor patient knows if the patient is receiving jnj-39758979 or placebo), multicenter, randomized (patients are assigned to treatment by chance), placebo-controlled, dose range finding study of jnj-39758979 in patients with stable methotrexate treatment through week 24. the study will consist of 4 periods: a screening period, a 24-week placebo-controlled period, a 24-week extension period, and a 5-week safety follow-up period. the duration of participation in the study for an individual patient will be up to 59 weeks (including screening). all patients will be randomly assigned in a 1:1:1:1:1 ratio to receive placebo or jnj-39758979 10 mg, 30 mg, 100 mg, or 300 mg once daily. at week 24, all patients remaining in the placebo group will start to receive jnj-39758979 300 mg/day. safety assessments and evaluations to determine the efficacy of jnj-39758979 to reduce the signs and symptoms of rheumatoid arthritis will be performed at study visits. the extension and safety follow-up periods of this study will continue through week 53 in order to assess the safety and for maintenance of efficacy of patients.

Eligibility criteria:
inclusion criteria: * has a diagnosis of rheumatoid arthritis (ra) for at least 6 months before screening. * positive test for either anti-cyclic citrullinated peptide (anti-ccp) antibody or rheumatoid factor (rf) in serum at screening. * has active ra defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints, and serum crp ≥ 0.70 mg/dl at screening. * has been treated with and tolerated methotrexate (mtx) treatment at dosages of 10 to 25 mg/week for a minimum of 6 months prior to screening and must be on a stable dose for a minimum of 8 weeks prior to screening * must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control * has completed at least 5 days of daily pain diary in the 10 days prior to randomization. exclusion criteria: * has inflammatory diseases other than ra, such as lupus. * is currently receiving treatment for ra other than methotrexate, nsaids, or oral corticosteroids such as prednisone, or pain medicines. * has ever received any biologic agent for a rheumatic indication. * has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled. * has moderate or severe renal insufficiency * has a recent (within 2 months) serious infection * has had an opportunistic infection. * has had cancer within the past 5 years (except certain skin or cervical conditions) * has abused substances or alcohol within the past 2 years * has active hepatitis b or c infection * has had active tuberculosis * has had exposure to tuberculosis without preventative treatment

Keywords: rheumatoid arthritis swollen and tender joints dose range finding study concurrent treatment with methotrexate