NCT05279417Phase 2Completed

ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Participants With Moderate to Severe Active Rheumatoid Arthritis (RA)

Study sponsor: Aclaris Therapeutics, Inc. · ACRS

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Primary completion2023-09-05Actual
Enrollment · participants251Actual
Source updated2026-09-28Last update listed in the registry record
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Primary outcomes · main study measures

Text edit · unverified significance
− Previous value

measure: Proportion of patients achieving ACR20 at Week 12; timeFrame: Baseline to Week 12

+ Updated value

measure: Percentage of Participants Achieving ACR20 at Week 12; description: Participants achieving American College of Rheumatology (ACR) 20 (responders) were defined as having ≥20% improvement in both the number of swollen and tender joints (66/68 joint counts) and ≥20% improvement in ≥3 of the following 5 measures: Patient's Global Assessment of Disease Activity (VAS), Patient's Assessment of Arthritis Pain (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), Physician's Global Assessment of Disease Activity (VAS), and acute phase reactant as measured by hsCRP. Model-based estimates and 95% confidence intervals (CIs) were produced.; timeFrame: Week 12

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