Phase 2
Completed N=31
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
| Outcome | Result | p-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.
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.