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

This study is currently recruiting participants.
Verified April 2014 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01862224
First received: May 2, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: JNJ-38518168
Drug: Placebo
Drug: Placebo / JNJ-38518168
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Assessment of rheumatoid arthritis (RA) biomarkers [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]
    Biomarkers may include, but are not limited to, inflammatory markers and cytokines; synovium/cartilage/bone markers; and gene expression profiles.


Secondary Outcome Measures:
  • Number of participants reporting adverse events as a measure of safety and tolerability [ Time Frame: Up to Week 56 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: July 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JNJ-38518168 Drug: JNJ-38518168
JNJ-38518168 30 mg once daily, Week 0 to Week 52.
Placebo Comparator: Placebo / JNJ-38518168 Drug: Placebo
Matching placebo once daily (Week 0 to Week 12).
Drug: Placebo / JNJ-38518168
JNJ-38518168 30 mg once daily, Week 12 to Week 52.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01862224

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
United States, California
Withdrawn
La Jolla, California, United States
United States, Maryland
Recruiting
Frederick, Maryland, United States
United States, Texas
Completed
Mesquite, Texas, United States
Moldova, Republic of
Recruiting
Chisinau, Moldova, Republic of
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01862224     History of Changes
Other Study ID Numbers: CR100963, 38518168ARA2003, 2011-006325-18
Study First Received: May 2, 2013
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Active rheumatoid arthritis despite methotrexate therapy
JNJ-38518168
Synovial

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014