ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acerta Pharma BV
• Treatments: Acalabrutinib; Methotrexate

Criteria

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.