Status:
WITHDRAWN
A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Active Rheumatoid Arthritis; Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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-contro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01480388
Start Date
December 1 2011
End Date
March 1 2014
Last Update
December 1 2016
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