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

Phase 1

• Conditions: Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors; MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-002887-17-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-16
• Study Completion: 2018-05-03
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 508

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 inhibiotrs
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 488
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified