Conditions: Rheumatoid Arthritis
Keywords: Acalabrutinib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief summary:
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.

Detailed description:
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

Arms:
arm 1: Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week arm 2: Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week

Interventions: intervention 1: acalabrutinib intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: