Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Methotrexate; Drug: BMS-986142

Study type: Interventional

Funder types: Industry

Identifiers

NCT02638948

IM006-016

2015-002887-17 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.

Enrollment: 508 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Male and female age 18 and above
• Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks before screening, have functional ACR class I-III
• Have an inadequate response to methotrexate
• In addition to an inadequate response to methotrexate have an inadequate response or intolerance to 1 but not more than 2 TNF inhibitors
• Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)
• Have hsCRP of ≥ 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR ≥ 28 mm/hr
• Willing to use effective birth control for the entire length of the study

Exclusion Criteria:

• Diagnosed with juvenile Rheumatoid Arthritis
• Have been treated with other biologic treatment than a TNF inhibitor
• Active systemic bacterial, viral or fungal infection or evidence of prior or current Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal infections
• Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4 weeks of randomization
• Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)
• Have other autoimmune disease other than RA like lupus, multiple sclerosis
• Have significant concurrent medical condition at the time of screening or baseline visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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508 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo + Methotrexate dose as specified

Treatment:

Drug: Placebo

Drug: Methotrexate

Dose Level 1

Experimental group

Description:

BMS-986142 at dose level 1+ Methotrexate as specified

Treatment:

Drug: BMS-986142

Drug: Methotrexate

Dose Level 2

Experimental group

Description:

BMS-986142 at dose level 2 + Methotrexate as specified

Treatment:

Drug: BMS-986142

Drug: Methotrexate