ACP-196 Versus Placebo 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

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.