A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy and Safety of Oral AP1189 Administered at the Doses of 40, 70, or 100 mg for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Participants With Early Rheumatoid Arthritis and Active Inflammation.
SynAct Pharma Aps
Summary
The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.
Description
The purpose of the trial is to evaluate the efficacy, safety and tolerability of 12 weeks daily treatment of oral AP1189 at the doses of 40, 70, or 100 mg in combination with oral MTX compared to oral MTX alone. The aim is to have 240 participants randomized to one of the 4 treatment groups, in a 1:1:1:1 ratio and treated with both AP1189/Placebo and MTX.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Signed and dated informed consent obtained before undergoing any trial-specific procedure. * Participants with definite RA diagnosis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. * Disease duration no longer than 6 months from diagnosis at the time of Baseline Visit and with a history of RA symptoms which does not exceed 18 months. * Participants must be naïve to any Disease-modifying anti-rheumatic drugs (DMARDs) * Participants with at least 6/68 tender and 6/66 swollen joints at Screenin…
Interventions
- DrugAP1189, 40 mg
AP1189 tablets for oral use
- DrugAP1189, 70 mg
AP1189 tablets for oral use
- DrugAP1189, 100 mg
AP1189 tablets for oral use
- DrugAP1189 matching placebo
AP1189 tablets for oral use
Locations (11)
- Nouvelle Clinical Research LLCCutler Bay, Florida
- Millennium Medical Research LLCMiami, Florida
- Altoona Center for Clinical ResearchDuncansville, Pennsylvania
- Diagnostic Consultative Center AleksandrovskaSofia
- Medical Center Tera MedicoVratsa
- Sanos Clinic HerlevHerlev