ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/4/2019 |
Start Date: | April 2015 |
End Date: | June 2016 |
A Phase 2a, 4-Week, Double-Blind, Proof-of-Concept Efficacy and Safety Study of ACP-196 Versus Placebo in Subjects With Active Rheumatoid Arthritis on Background Methotrexate
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and
efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial.
The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week
safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the
safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background
Methotrexate
The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week
safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the
safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background
Methotrexate
Main Inclusion Criteria:
- Diagnosis of RA according to the 2010 ACR/EULAR Classification Criteria .
- Must be on a stable MTX dose (7.5 to 25 mg/week)
- Subjects must be able to read and understand the consent form, complete the
study-related procedures, and communicate with the study staff.
- Are willing and able to adhere to the study visit schedule, and understand and comply
with other protocol requirements.
Main Exclusion Criteria:
- Prior malignancy, except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer from which the subject has been
disease free for ≥ 5 years.
- A life-threatening illness, medical condition or organ system dysfunction which, in
the investigator's opinion, could compromise the subject's safety, interfere with the
absorption or metabolism of ACP-196, or put the study outcomes at undue risk.
- Subjects who have taken any investigational drug within the previous 30 days before
randomization.
- Use of all other synthetic disease-modifying antirheumatic drugs (DMARDS) such as but
not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts
within 8 weeks of randomization.
- Use of etanercept, anakinra, tofacitinib within 4 weeks of randomization.
- Use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.
We found this trial at
16
sites
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