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

Phase 2

• Conditions: rheuma; 10003816

• Registration Number: NL-OMON33287
• Lead Sponsor: Janssen-Cilag

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

- Have a diagnosis of Rheumatoid Arthritis (RA) at screening established as
positive for either anti-cyclic citrullinated peptide (anti-CCP) antibody or
Rheumatoid Factors (RF) in serum at screening.
- Have active RA at screening and at baseline (for joint count only). Active RA is
defined for the purpose of this study as persistent disease activity with both of the
following criteria:
a. Serum CRP > upper limit of normal at screening only.
b. 66/68 Joint Count as follows:
* Primary study subjects: at least 6 swollen and 6 tender joints using a
66/68 joint count at the time of screening and at baseline
* Synovial biopsy substudy subjects: at least 4 swollen and 4 tender joints
using a 66/68 joint count with a clinically inflamed knee or ankle joint at
the time of screening and at baseline.
- Have been treated with and tolerated MTX treatment at dosages between 7.5 to 25
mg/week inclusive, for a minimum of 4 months prior to Screening and must have
a stable MTX dose for a minimum of 4 weeks prior to the first study drug dose.

Exclusion Criteria

- Have a diagnosis of Rheumatoid Arthritis Functional Class IV according to the
American College of Rheumatology criteria which has been ongoing for at least 6
months prior to the first dose of study medication.
- Have inflammatory diseases other than RA, (including but not limited to ankylosing
spondylitis, systemic lupus erythematosus, and Lyme disease).
- Have 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 in the Investigator*s discretion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>STUDY ENDPOINTS<br /><br>Primary<br /><br>* Change from baseline in DAS28 (using CRP) score at Week 12</p><br>