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

Janssen (J&J Innovative Medicine)

Status and phase: Withdrawn; Phase 2

Conditions: Active Rheumatoid Arthritis; Rheumatoid Arthritis

Treatments: Drug: JNJ-39758979 (300 mg); Drug: Placebo/JNJ-39758979 (300 mg/d); Drug: JNJ-39758979 (10 mg); Drug: JNJ-39758979 (30 mg); Drug: JNJ-39758979 (100 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01480388

CR018814

2011-002849-36 (EudraCT Number)

39758979ARA2001 (Other Identifier)

Details and patient eligibility

About

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).

Full 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-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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo/JNJ-39758979 (300 mg/d)

JNJ-39758979 (10 mg/d)

Experimental group

Treatment:

Drug: JNJ-39758979 (10 mg)

JNJ-39758979 (30 mg/d)

Experimental group

Treatment:

Drug: JNJ-39758979 (30 mg)

JNJ-39758979 (100 mg/d)

Experimental group

Treatment:

Drug: JNJ-39758979 (100 mg)

JNJ-39758979 (300 mg/d)

Experimental group

Treatment:

Drug: JNJ-39758979 (300 mg)