Mode
Text Size
Log in / Sign up
Phase 2 Completed N=31 Randomized Quadruple-blind Treatment

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

Source: ClinicalTrials.gov NCT02387762 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Disease Activity Score 28-CRP (DAS28-CRP) at Week 4 — 5.40; 5.05 Scores on scale

Summary

This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.

Outcome Measures

OutcomeResultp-value
PRIMARY
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
5.40; 5.05

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02387762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search