Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 8/3/2018 |
Start Date: | February 16, 2016 |
End Date: | May 3, 2018 |
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
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.
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.
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
We found this trial at
27
sites
Wexford, Pennsylvania 15090
Phone: 724-935-9355
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials