Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors.

Phase 2

Withdrawn

Conditions: Rheumatoid arthritis
Chronic inflammation of the joints
10003816

Registration Number: NL-OMON43673

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

* Males and Females, ages * 18 years old
* Diagnosis of adult-onset RA as defined by standard criteria (ACR/EULAR [2010]) at least 16 weeks prior to screening.
* ACR global functional status class of 1 to 3.
* Subjects must be MTX inadequate responders based on investigator*s judgment.
* Subject failed or was intolerant to * 2 TNF inhibitor(s)
* Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at Screening Visit
* Subjects must have a hsCRP of * 0.8 mg/dL (8mg/L) or an ESR * 28 mm/hr at Screening
* WOCBP and males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986142 plus 90 days post-treatment completion for WOCBP and 93 days post treatment completion for men.

Exclusion Criteria

* Subjects with documented juvenile rheumatoid arthritis or Felty*s syndrome
* Biologic treatments other than TNF inhibitors.
* Subjects who are currently receiving immunomodulators other than methotrexate.
* Subjects who have been treated with Intramuscular (IM) or Intra-articular glucocorticosteroids within 4 weeks of randomization (Day 1). Oral steroid use is permitted, but only if * 10 mg/day of prednisone (or prednisone equivalent).
* Subjects with any bacterial infection within the last 60 days prior to screening (enrollment), unless treated and resolved with antibiotics, or any chronic or history of recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis).
* Subjects who have a history of systemic fungal infections (such as histoplasmosis, blastoplasmosis, or coccidioides).
* Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infection at the time of potential enrollment, including subjects with history or evidence of Hepatitis B or Hepatitis C, history or evidence of Human Immunodeficiency Virus (HIV) infection, or who test positive on HIV test at screening.
* Subjects with autoimmune disease other than RA (eg, Systemic lupus erythematosus [SLE], multiple sclerosis [MS], vasculitis).
* Significant concurrent medical condition at the time of screening or baseline visit

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Co-Primary Endpoint:<br /><br>* ACR20 response rate at week 12<br /><br>* ACR70 response rate at week 12</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary Endpoints:<br /><br>* Signs and Symptoms: ACR20/ACR50/70 over time<br /><br>* Remission and change from baseline: DAS28-CRP, DAS-ESR, SDAI, CDAI, Boolean<br /><br>over time<br /><br>* PK: Ctrough of BMS-986142<br /><br>* Change in RAMRIS Scores of synovitis, osteitis, bone erosion and cartilage<br /><br>loss from baseline to week 4 and week 12</p><br>