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.

Rheumatoid Arthritis

Change from Baseline in DAS28(CRP) after 12 weeks of combined treatment with AP1189/Placebo and MTX

ACR20 responder rate at Week 12, ACR50 responder rate at Week 12, ACR70 responder rate at Week 12, Change from baseline of the 7 individual components of the ACR criteria (tender/painful joint count, swollen joint count, Patient’s assessment of arthritis pain, Patient Global Assessment of arthritis (PtGA), Physician Global Assessment of arthritis (PhGA), HAQ-DI, serum CRP) at each time point, Change from baseline in DAS28 at each time point, Proportion of participants with Low, Moderate, or High Disease Activity based on DAS28 at each time point, Proportion of participants fulfilling DAS28 remission criteria at each time point (DAS28<2.6), Proportion of participants achieving a Good EULAR response (a DAS28 score≤3.2 at the considered visit, together with an improvement from baseline in DAS28>1.2) at each time point, Change from baseline in SDAI and CDAI at each time point, Proportion of participants with Low, Moderate, or High Disease Activity based on SDAI and CDAI at each time point, Proportion of participants fulfilling the ACR/EULAR remission criteria at each time point, Proportion of participants achieving HAQ DI MCID (>0.22 reduction in HAQ DI from baseline)

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