A randomized, double blind, placebo-controlled, phase II, multicentre trial to explore the efficacy and safety of oral AP1189 tablets administered at the dose 100 mg/day for 12 weeks in patients diagnosed with polymyalgia rheumatica and in remission on glucocorticoid

Polymyalgia rheumatica

Safety evaluations include adverse event monitoring, physical examinations, vital sign measurements, and clinical laboratory testing.

To investigate the effect of 100 mg/day AP1189 tablets against placebo tablets by evaluating the proportion of patients in glucocorticoid free remission at week, To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: • Accumulated glucocorticoid dosage from baseline to week 12. • Time to first relapse from baseline to week 12. • Glucocorticoid free remission at week 12 (Remission defined as PMR-AS<10)., To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: PMR activity score at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest., To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient global VAS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest, To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: SF-36 MCS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest, To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: SF-36 PCS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest, To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: HAQ-DI at week 4, 8, and 12 with the change from baseline to week 12 being of primary in-terest., To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient reported PMR VAS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest, To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient reported global VAS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest., To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient reported fatigue VAS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest, To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient reported morning stiffness VAS at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest., To investigate the effects of 100 mg/day AP1189 tablets against placebo tablets by evaluating: Patient reported duration of morning stiffness at week 4, 8, and 12 with the change from baseline to week 12 being of primary interest

No related papers found yet.