A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: JNJ-38518168 (30 mg); Drug: JNJ-38518168 (10 mg); Drug: Placebo; Drug: JNJ-38518168 (3 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01679951

2011-002840-29 (EudraCT Number)

38518168ARA2002 (Other Identifier)

CR100734

Details and patient eligibility

About

The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.

Full description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), multicenter, placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), dose range finding study of JNJ-38518168 in patients with active RA despite concomitant MTX therapy. The study will consist a screening period, a 24-week placebo-controlled period and a 4-week follow-up period between the last dose and the last visit. The duration of participation in the study for an individual patient will be up to 34 weeks (including screening). The patients will be assigned to 1 of 4 treatment groups in a 1:1:1:1 ratio to placebo and JNJ-38518168 (3 mg or 10 mg or 30 mg). Safety assessments and evaluations to determine the efficacy of JNJ-38518168 to reduce the signs and symptoms of RA will be performed at study visits. Safety will be monitored throughout the study.

Enrollment: 272 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has had rheumatoid arthritis for at least 6 months prior to the date of signing the informed consent at screening
• Must be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening
• Must have active rheumatoid arthritis (at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline and Serum C reactive protein greater than or equal to 0.80 mg/dL at the time of screening
• Has been treated with and tolerated methotrexate treatment at dosages from 10 to 25 mg/week inclusive, for a minimum of 6 months with stable dose for at least 8 weeks prior to the date of signing the informed consent at screening

Exclusion criteria

• Has inflammatory diseases other than rheumatoid arthritis, including but not limited to adult onset Still's disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and Lyme disease that might confound the evaluation of the benefit of study agent therapy
• Has current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled
• Has ever received any approved or investigational biologic agent for a rheumatoid indication
• Has been treated with any nonbiologic disease modifying antirheumatic drugs within 4 weeks prior to the first administration of study agent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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272 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Methotrexate

Drug: Placebo

JNJ-38518168 (3 mg/d)

Experimental group

Treatment:

Drug: Methotrexate

Drug: JNJ-38518168 (3 mg)

JNJ-38518168 (10 mg/d)

Experimental group

Treatment:

Drug: Methotrexate

Drug: JNJ-38518168 (10 mg)

JNJ-38518168 (30 mg/d)

Experimental group

Treatment:

Drug: Methotrexate

Drug: JNJ-38518168 (30 mg)