Phase IIB, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to Methotrexate.

Phase 2

Completed

Conditions: Chronic inflammation of the joints
Rheumatoid arthritis
10003816

Registration Number: NL-OMON38282

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

a) Men and Women, ages >= 18 years
b) Subjects have a documented diagnosis of active RA by standard criteria (ARA [1987] or ACR/EULAR [2010]) at least 16 weeks prior to screening.
c) Subjects have an ACR global functional status class of 1 to 3.
(d) Subjects must be methotrexate inadequate responders. Subjects must have been taking methotrexate for at least 3 months at a minimal weekly dose of >=15 mg, and at a stable dose for 4 weeks prior to randomization (Day 1). A methotrexate weekly dose as low as 10 mg is only permitted if there is verifiable documentation in the medical record prior to entry into the study that the subject did not respond to at least 15 mg or higher dose and the dose is reduced for toxicity/intolerability.
e) Subjects have a minimum of 6 swollen and 6 tender joints on a 66/68 joint count on screening visit #1 for those not requiring washout and on screening visit #2 for those requiring washout.
f) Evidence of synovitis in at least 1 hand or wrist by clinical examination on screening visit #1 for those not requiring washout and on screening visit #2 for those requiring washout.
g) Subjects have a hsCRP of >= 0.8 mg/dL (8mg/L) [by central laboratory values] on screening visit #1 for those not requiring washout and on screening visit #2 for those requiring washout.

Exclusion Criteria

a) Subjects with documented juvenile rheumatoid arthritis.
b) Subjects who have previously received or are currently receiving an approved biologic therapy for RA (the eligibility of other Biologic therapies including experimental therapies should be discussed with the BMS Medical Monitor)
c) Subjects who treated with leflunomide based on the following conditions:
i) currently treated with leflunomide prior to screening:
(1) Subjects will be allowed to enroll only if they are willing to undergo the drug elimination procedure found in section 3.1.1 after stopping treatment with leflunomide and wait for an
additional 10 weeks (5 half-lives)
ii) no longer treated with leflunomide prior to screening:
(2) Leflunomide plasma levels will be obtained at Screening; if the levels are non-detectable [less than 0.02 mg/L or 0.02 mcg/mL], the subject is eligible to enroll immediately if they have not been treated with leflunomide within 10 weeks prior to Screening. If there are still detectable leflunomide plasma levels, the subject may enroll only if they follow the drug elimination procedure found in section 3.1.
d) Subjects who are currently receiving calcineurin inhibitors.
e) Subjects who are currently receiving nimesulide.
f) Subjects using parenteral MTX for administration of their weekly dose.
g) Subjects who have been treated with IM or IA glucocorticosteroids within 4 weeks of randomization (Day 1).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective During Double-Blind Period:<br /><br>To compare the efficacy of BMS-945429 SC versus placebo on a background of<br /><br>methotrexate as assessed by ACR20 response rates at 12 weeks.<br /><br><br /><br>Long-term Extension Period Primary Objective:<br /><br>Assess the long-term clinical safety and tolerability of BMS-945429 treatment<br /><br>during the Long-term Extension Period.</p><br>

Secondary Outcome Measures