A Synovial Biopsy Study of JNJ-38518168 in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

NCT ID: NCT01862224

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-07-31

Brief Summary

The purpose of this study is to assess the impact of JNJ-38518168 on rheumatoid arthritis (RA) disease-related biomarkers in synovial biopsy tissue and blood in participants with active RA despite methotrexate (MTX) therapy and to assess the safety and tolerability of JNJ-38518168 over one year.

Detailed Description

This is a randomized (participants assigned to treatment by chance), double-blind (participants and study personnel will not know what treatment is being given), placebo-controlled (a placebo appears identical to a study drug, but contains no active ingredients), parallel-group (treatments will be given to groups of participants at the same time) study. Participants will be randomly assigned in a 3:1 ratio to receive either JNJ-38518168 for 52 weeks or receive matching placebo for 12 weeks, followed by JNJ-38518168 for 40 weeks. The total duration of participation will be approximately 60 weeks for all participants, including a screening visit and follow-up visits. Safety and tolerability of JNJ-38518168 will be evaluated by monitoring adverse events reported by participants throughout the study . In addition, results from clinical laboratory tests, electrocardiograms, vital signs measurements, and physical examinations performed during the study will be monitored.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

JNJ-38518168

JNJ-38518168 30 mg once daily for 52 weeks.

Group Type: EXPERIMENTAL

JNJ-38518168

Intervention Type: DRUG

JNJ-38518168 30 mg once daily, Week 0 to Week 52.

Methotrexate

Intervention Type: DRUG

All participants will continue receiving methotrexate up to Week 12. After Week 12, the dose of methotrexate may be adjusted as per Investigator's discretion.

Placebo/JNJ-38518168

Matching placebo once daily for 12 weeks followed by JNJ-38518168 30 mg once daily for 40 weeks.

Group Type: PLACEBO_COMPARATOR

JNJ-38518168

Intervention Type: DRUG

JNJ-38518168 30 mg once daily, Week 0 to Week 52.

Placebo

Intervention Type: DRUG

Matching placebo once daily (Week 0 to Week 12).

Methotrexate

Intervention Type: DRUG

All participants will continue receiving methotrexate up to Week 12. After Week 12, the dose of methotrexate may be adjusted as per Investigator's discretion.

Interventions

JNJ-38518168

JNJ-38518168 30 mg once daily, Week 0 to Week 52.

Intervention Type: DRUG

Placebo

Matching placebo once daily (Week 0 to Week 12).

Intervention Type: DRUG

Methotrexate

All participants will continue receiving methotrexate up to Week 12. After Week 12, the dose of methotrexate may be adjusted as per Investigator's discretion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have had rheumatoid arthritis (RA) for at least 6 months prior to the date of signing the informed consent at screening
• Be positive for either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum at screening
• Have active RA defined for the purpose of this study as persistent disease activity with both of the following criteria: At least 4 swollen and 4 tender joints using a 66/68 joint count. At the time of screening, one of the tender or swollen joints or both must include the non-prosthetic knee to be biopsied; and serum C-reactive protein (CRP_ ≥ 0.60 mg/dL at screening
• Have been treated with and tolerated oral methotrexate (MTX) treatment at doses from 10 mg/week to 25 mg/week inclusive, for a minimum of 3 months prior to the date of signing the informed consent at screening and must have a stable MTX dose for a minimum of 8 weeks prior to the date of signing the informed consent at screening and continue to receive the same MTX dose at Week 0
• If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (pain relievers) regularly for RA, the participant must have been on a stable dose for at least 2 weeks prior to the first administration of study agent. If not using NSAIDs or other analgesics for RA at Week 0, the participant must have not received NSAIDs or other analgesics for RA for at least 2 weeks prior to the first administration of study agent

Exclusion Criteria

• Has inflammatory diseases other than RA
• Has a history of juvenile idiopathic arthritis (JIA)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Frederick, Maryland, United States

Chisinau, , Moldova

Countries

United States; Moldova

Other Identifiers

38518168ARA2003

Identifier Type: OTHER

Identifier Source: secondary_id

2011-006325-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100963

Identifier Type: -

Identifier Source: org_study_id