ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387762
• Other study ID #: ACE-RA-001
• Status: Completed
• Phase: Phase 2
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2019
• Source: Acerta Pharma BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• acalabrutinib

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Acerta Pharma BV

Country where clinical trial is conducted

United States, 

Outcome

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