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

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ClinicalTrials.gov Identifier: NCT02387762
Recruitment Status : Completed
First Posted : March 13, 2015
Results First Posted : March 26, 2019
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: acalabrutinib Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ACP-196 + Methotrexate
Oral acalabrutinib 15 mg QD plus a stable dose of methotrexate (MTX) between 7.5 mg and 25 mg per week
Drug: acalabrutinib
Other Name: methotrexate

Placebo Comparator: Placebo + Methotrexate
Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
Drug: Placebo
Other Name: methotrexate

Primary Outcome Measures :
  1. Disease Activity Score 28-CRP (DAS28-CRP) at Week 4 [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02387762

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Sponsors and Collaborators
Acerta Pharma BV
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Study Director: Acerta Clinical Trials Acerta Pharma, LLC
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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02387762    
Other Study ID Numbers: ACE-RA-001
First Posted: March 13, 2015    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: April 2, 2019
Last Verified: March 2019
Keywords provided by Acerta Pharma BV:
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors