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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02387762
• Date of registration: 01/03/2015
• Prospective Registration: Yes
• Primary sponsor: Acerta Pharma BV
• Public title: ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
• Scientific 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
• Date of first enrolment: April 2015
• Target sample size: 31
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02387762
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Acerta Clinical Trials
• Affiliation: Acerta Pharma, LLC

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: acalabrutinib

Drug: Placebo

Primary Outcome(s)

Disease Activity Score 28-CRP (DAS28-CRP) at Week 4 [Time Frame: 4 weeks]

Secondary ID(s)

ACE-RA-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02387762