The RESOLVE study is a two-part, randomized, double-blind, multi-center, placebo-controlled study of the safety, dose-range finding confirmation, and efficacy of 4 (Part A) and 12 weeks (Part B) of treatment with AP1189 in adult RA patients with an inadequate response to MTX alone.
In Part A approximately 120 randomized patients will be treated with either 60 mg AP1189, 80 mg AP1189, 100 mg AP1189 or placebo once daily for 4 weeks as add-on treatment to stable MTX treatment. Part A will conclude with an unblinded assessment for risk/benefit and a recommendation for dose selection for Part B. In Part B patients will be randomized into groups of equal size evaluating 2-3 doses of AP1189 versus placebo. All doses will be administered once daily for 12 weeks as add-on treatment to stable MTX treatment. The proposed sample size per dose group/placebo group is 75 patients, by which the total study population of Part B may be either 225 or 300 patients, depending on the number of dose groups of AP1189 selected for evaluation based on Part A.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
125
AP1189 tablets for oral use
AP1189 tablets for oral use
AP1189 tablets for oral use
Timofei Mosneaga Republican Clinical Hospital
Chisinau, Moldova
Part A: Change in ACR20
The change in American College of Rheumatology 20% (ACR20) compared to baseline
Time frame: 4 weeks
Part B: Change in ACR20
The change in American College of Rheumatology 20% (ACR20) compared to baseline
Time frame: 12 weeks
Number of reported Adverse Events
Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo
Time frame: 12 weeks
Part A: Change in ACR50
The change in American College of Rheumatology 50% (ACR50) compared to baseline
Time frame: 4 weeks
Part B: Change in ACR50
The change in American College of Rheumatology 50% (ACR50) compared to baseline
Time frame: 12 weeks
Part A: Change in ACR70
The change in American College of Rheumatology 70% (ACR70) compared to baseline
Time frame: 4 weeks
Part B: Change in ACR70
The change in American College of Rheumatology 70% (ACR70) compared to baseline
Time frame: 12 weeks
Part A: Change in CDAI
The change Clinical Disease Activity Index (CDAI) compared to baseline
Time frame: 4 weeks
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Matching placebo tablets for oral use
Part B: Change in CDAI
The change Clinical Disease Activity Index (CDAI) compared to baseline
Time frame: 12 weeks
Part A: Change in DAS-28
The change in Disease Activity Score (DAS-28), based on a C-Reactive Protein (CRP) value, compare to baseline
Time frame: 4 weeks
Part B: Change in DAS-28
The change in Disease Activity Score (DAS-28), based on a C-Reactive Protein (CRP) value, compare to baseline
Time frame: 12 weeks