Clinical trial NCT02387762: ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Acalabrutinib
Lead sponsor: Acerta Pharma BV
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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.

Primary outcomes:
measure: Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Scottsdale
country: United States
facility: Advanced Arthritis Care and Research
state: Arizona
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Santa Monica
country: United States
facility: Pacific Arthritis Center Medical Group
state: California
city: Upland
country: United States
facility: Inland Rheumatology and Osteoporosis Medical Group, Inc
state: California
city: Hialeah
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center
state: Florida
city: Las Vegas
country: United States
facility: Office of George Timothy Kelly, MD
state: Nevada
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Memphis
country: United States
facility: Ramesh C. Gupta, MD
state: Tennessee
city: Webster
country: United States
facility: Clear Lake Regional Medical Center
state: Texas
Study officials:
affiliation: Acerta Pharma, LLC
name: Acerta Clinical Trials
role: STUDY_DIRECTOR
References: