At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 105 enrolled
Drug / intervention
50 mg AP1189 +2 moredrug
Likely dose
50 mg AP1189from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint Disease
In Brief
A Phase 2 clinical trial evaluating 50 mg AP1189, AP1189, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 105 participants across 2 sites in 2 countries.
Detailed Summary
This is a multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) \> 22, who are to start up-titration with methotrexate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesDenmark, Norway
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartAug 2019
Primary CompletionNov 2021
TodayJul 2026
First PostedJul 2, 2019
Enrollment StartAug 26, 2019
Primary CompletionNov 16, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7 years ago
Interventions
50 mg AP1189drug
50 mg AP1189 powder in bottle
AP1189drug
100 mg AP1189 powder in bottle
Placebodrug
Placebo powder in bottle