- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02387762
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
March 25, 2019 updated by: Acerta Pharma BV
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
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Anniston, Alabama, United States, 36207
- Pinnacle Research Group
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Birmingham, Alabama, United States, 35216
- Achieve Clinical Research
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Arizona
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Scottsdale, Arizona, United States, 85258
- Advanced Arthritis Care and Research
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California
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El Cajon, California, United States, 92020
- TriWest Research Associates, LLC
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Orange, California, United States, 92868
- Neuropsychiatric Research Center of Orange County
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Santa Monica, California, United States, 93454
- Pacific Arthritis Center Medical Group
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Upland, California, United States, 91786
- Inland Rheumatology and Osteoporosis Medical Group, Inc
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Florida
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Hialeah, Florida, United States, 33015
- San Marcus Research Clinic, Inc.
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New Port Richey, Florida, United States, 34652
- Suncoast Clinical Research
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New Port Richey, Florida, United States, 34652
- Suncoast Clinical Research, Inc.
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Palm Harbor, Florida, United States, 34684-3176
- The Arthritis Center
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Nevada
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Las Vegas, Nevada, United States, 89128
- Office of George Timothy Kelly, MD
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North Carolina
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Salisbury, North Carolina, United States, 28144
- PMG Research of Salisbury
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103-2433
- Health Research of Oklahoma
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Altoona Center For Clinical Research
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Tennessee
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Memphis, Tennessee, United States, 38119
- Ramesh C. Gupta, MD
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Texas
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Webster, Texas, United States, 77598
- Clear Lake Regional Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACP-196 + Methotrexate
Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
|
Other Names:
|
Placebo Comparator: Placebo + Methotrexate
Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
Time Frame: 4 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Acerta Clinical Trials, Acerta Pharma, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
March 1, 2015
First Submitted That Met QC Criteria
March 9, 2015
First Posted (Estimate)
March 13, 2015
Study Record Updates
Last Update Posted (Actual)
April 2, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Acalabrutinib
Other Study ID Numbers
- ACE-RA-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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