Rheumatoid Arthritis Clinical Trial
Official title:
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
NCT number | NCT02387762 |
Other study ID # | ACE-RA-001 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | June 2016 |
Verified date | March 2019 |
Source | Acerta Pharma BV |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
Status | Completed |
Enrollment | 31 |
Est. completion date | June 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Pinnacle Research Group | Anniston | Alabama |
United States | Achieve Clinical Research | Birmingham | Alabama |
United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
United States | TriWest Research Associates, LLC | El Cajon | California |
United States | San Marcus Research Clinic, Inc. | Hialeah | Florida |
United States | Office of George Timothy Kelly, MD | Las Vegas | Nevada |
United States | Ramesh C. Gupta, MD | Memphis | Tennessee |
United States | Suncoast Clinical Research | New Port Richey | Florida |
United States | Suncoast Clinical Research, Inc. | New Port Richey | Florida |
United States | Health Research of Oklahoma | Oklahoma City | Oklahoma |
United States | Neuropsychiatric Research Center of Orange County | Orange | California |
United States | The Arthritis Center | Palm Harbor | Florida |
United States | PMG Research of Salisbury | Salisbury | North Carolina |
United States | Pacific Arthritis Center Medical Group | Santa Monica | California |
United States | Advanced Arthritis Care and Research | Scottsdale | Arizona |
United States | Inland Rheumatology and Osteoporosis Medical Group, Inc | Upland | California |
United States | Clear Lake Regional Medical Center | Webster | Texas |
Lead Sponsor | Collaborator |
---|---|
Acerta Pharma BV |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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