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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
acalabrutinib
Placebo
Sponsored by
Acerta Pharma BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Acalabrutinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pinnacle Research Group
  • Achieve Clinical Research
  • Advanced Arthritis Care and Research
  • TriWest Research Associates, LLC
  • Neuropsychiatric Research Center of Orange County
  • Pacific Arthritis Center Medical Group
  • Inland Rheumatology and Osteoporosis Medical Group, Inc
  • San Marcus Research Clinic, Inc.
  • Suncoast Clinical Research, Inc.
  • Suncoast Clinical Research
  • The Arthritis Center
  • Office of George Timothy Kelly, MD
  • PMG Research of Salisbury
  • Health Research of Oklahoma
  • Altoona Center for Clinical Research
  • Ramesh C. Gupta, MD
  • Clear Lake Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ACP-196 + Methotrexate

Placebo + Methotrexate

Arm Description

Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week

Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2015
Last Updated
March 25, 2019
Sponsor
Acerta Pharma BV
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1. Study Identification

Unique Protocol Identification Number
NCT02387762
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acerta Pharma BV

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Acalabrutinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACP-196 + Methotrexate
Arm Type
Experimental
Arm Description
Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
Arm Title
Placebo + Methotrexate
Arm Type
Placebo Comparator
Arm Description
Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
Intervention Type
Drug
Intervention Name(s)
acalabrutinib
Other Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
methotrexate
Primary Outcome Measure Information:
Title
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Acerta Clinical Trials
Organizational Affiliation
Acerta Pharma, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Achieve Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Advanced Arthritis Care and Research
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Arthritis Center Medical Group
City
Santa Monica
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Inland Rheumatology and Osteoporosis Medical Group, Inc
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
The Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684-3176
Country
United States
Facility Name
Office of George Timothy Kelly, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103-2433
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Ramesh C. Gupta, MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clear Lake Regional Medical Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States

12. IPD Sharing Statement

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

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