A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate

• Status: Withdrawn
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Methotrexate

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