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

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Synovial Biopsy Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01862224
• Other study ID #: CR100963
• Secondary ID: 38518168ARA20032
• Status: Terminated
• Phase: Phase 2
• First received: May 2, 2013
• Last updated: June 12, 2015
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: June 2015
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• JNJ-38518168
JNJ-38518168 30 mg once daily, Week 0 to Week 52.
• Placebo
Matching placebo once daily (Week 0 to Week 12).
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of rheumatoid arthritis (RA) biomarkers	Biomarkers may include, but are not limited to, inflammatory markers and cytokines; synovium/cartilage/bone markers; and gene expression profiles.	Up to Week 52	No
Secondary	Number of participants reporting adverse events as a measure of safety and tolerability		Up to Week 56	No