ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
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
1 other identifier
interventional
31
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started Apr 2015
Shorter than P25 for phase_2 rheumatoid-arthritis
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
March 26, 2019
CompletedApril 2, 2019
March 1, 2019
1.1 years
March 1, 2015
January 28, 2019
March 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
Disease activity score 28 - C-reactive protein (DAS28-CRP) is a score to measure disease activity in patients with rheumatoid arthritis by aggregating data of 28 joints, and is calculated by the scores on scale using the following variables: The number of swollen and tender joints, CRP level, and patient's global assessment of disease activity. The total score of the DAS28 values may range from 2.0 to 10.0 while higher values mean a higher disease activity.
4 weeks
Study Arms (2)
ACP-196 + Methotrexate
EXPERIMENTALOral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
Placebo + Methotrexate
PLACEBO COMPARATOROral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acerta Pharma BVlead
Study Sites (17)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Achieve Clinical Research
Birmingham, Alabama, 35216, United States
Advanced Arthritis Care and Research
Scottsdale, Arizona, 85258, United States
TriWest Research Associates, LLC
El Cajon, California, 92020, United States
Neuropsychiatric Research Center of Orange County
Orange, California, 92868, United States
Pacific Arthritis Center Medical Group
Santa Monica, California, 93454, United States
Inland Rheumatology and Osteoporosis Medical Group, Inc
Upland, California, 91786, United States
San Marcus Research Clinic, Inc.
Hialeah, Florida, 33015, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
The Arthritis Center
Palm Harbor, Florida, 34684-3176, United States
Office of George Timothy Kelly, MD
Las Vegas, Nevada, 89128, United States
PMG Research of Salisbury
Salisbury, North Carolina, 28144, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103-2433, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Ramesh C. Gupta, MD
Memphis, Tennessee, 38119, United States
Clear Lake Regional Medical Center
Webster, Texas, 77598, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ahmed Hamdy, MD, VP of Early Development
- Organization
- Acerta Pharma
Study Officials
- STUDY DIRECTOR
Acerta Clinical Trials
Acerta Pharma, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2015
First Posted
March 13, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
April 2, 2019
Results First Posted
March 26, 2019
Record last verified: 2019-03