ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
NCT ID: NCT02387762
Last Updated: 2019-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2015-04-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ACP-196 + Methotrexate
Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
acalabrutinib
Placebo + Methotrexate
Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
Placebo
Interventions
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acalabrutinib
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Acerta Pharma BV
INDUSTRY
Responsible Party
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Principal Investigators
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Acerta Clinical Trials
Role: STUDY_DIRECTOR
Acerta Pharma, LLC
Locations
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Pinnacle Research Group
Anniston, Alabama, United States
Achieve Clinical Research
Birmingham, Alabama, United States
Advanced Arthritis Care and Research
Scottsdale, Arizona, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Neuropsychiatric Research Center of Orange County
Orange, California, United States
Pacific Arthritis Center Medical Group
Santa Monica, California, United States
Inland Rheumatology and Osteoporosis Medical Group, Inc
Upland, California, United States
San Marcus Research Clinic, Inc.
Hialeah, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
The Arthritis Center
Palm Harbor, Florida, United States
Office of George Timothy Kelly, MD
Las Vegas, Nevada, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Ramesh C. Gupta, MD
Memphis, Tennessee, United States
Clear Lake Regional Medical Center
Webster, Texas, United States
Countries
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Other Identifiers
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ACE-RA-001
Identifier Type: -
Identifier Source: org_study_id
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