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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
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Tracking Information
First Submitted Date  ICMJE March 1, 2015
First Posted Date  ICMJE March 13, 2015
Results First Submitted Date  ICMJE January 28, 2019
Results First Posted Date  ICMJE March 26, 2019
Last Update Posted Date April 2, 2019
Study Start Date  ICMJE April 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4 [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT02387762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: acalabrutinib
    Other Name: methotrexate
  • Drug: Placebo
    Other Name: methotrexate
Study Arms  ICMJE
  • 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
    Intervention: Drug: acalabrutinib
  • Placebo Comparator: Placebo + Methotrexate
    Oral placebo QD plus a stable dose of MTX between 7.5 mg and 25 mg per week
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2016)
31
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2015)
70
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02387762
Other Study ID Numbers  ICMJE ACE-RA-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acerta Pharma BV
Study Sponsor  ICMJE Acerta Pharma BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Acerta Clinical Trials Acerta Pharma, LLC
PRS Account Acerta Pharma BV
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP