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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: acalabrutinib

• Registration Number: NCT02387762
• Lead Sponsor: Acerta Pharma BV

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

Study Timeline

• Study First Submitted: 2015-03-01
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-13
• Study Start: 2015-04
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Results First Submitted: 2019-01-28
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-25
• Results First Posted: 2019-03-26
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo + Methotrexate	Placebo	Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
ACP-196 + Methotrexate	acalabrutinib	Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week

Primary Outcome Measures

Name	Time	Method
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4	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.

Trial Locations

Locations (17)

San Marcus Research Clinic, Inc.; 🇺🇸 Hialeah, Florida, United States

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Health Research of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

Advanced Arthritis Care and Research; 🇺🇸 Scottsdale, Arizona, United States

Achieve Clinical Research; 🇺🇸 Birmingham, Alabama, United States

TriWest Research Associates, LLC; 🇺🇸 El Cajon, California, United States

Suncoast Clinical Research, Inc.; 🇺🇸 New Port Richey, Florida, United States

Pacific Arthritis Center Medical Group; 🇺🇸 Santa Monica, California, United States

Suncoast Clinical Research; 🇺🇸 New Port Richey, Florida, United States

Office of George Timothy Kelly, MD; 🇺🇸 Las Vegas, Nevada, United States

PMG Research of Salisbury; 🇺🇸 Salisbury, North Carolina, United States

Ramesh C. Gupta, MD; 🇺🇸 Memphis, Tennessee, United States

Inland Rheumatology and Osteoporosis Medical Group, Inc; 🇺🇸 Upland, California, United States

The Arthritis Center; 🇺🇸 Palm Harbor, Florida, United States

Clear Lake Regional Medical Center; 🇺🇸 Webster, Texas, United States

Neuropsychiatric Research Center of Orange County; 🇺🇸 Orange, California, United States