Protocol Info

Sponsor: Tremeau Pharmaceuticals, Inc.
Indication: Hemophilic Arthropathy
Protocol Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Study with a Long-Term Extension to Evaluate the Efficacy and Safety of TRM-201 (Rofecoxib) in Patients with Hemophilic Arthropathy (RESET-HA)
Phase: 3
Patient Population: Patients aged 12 to 75 years of age with a history of hemophilic arthropathy due to hemophilia A, B
Number of Patients: 160 patients randomized (80 per treatment arm)
Number of Study Centers: Up to 70 (US and ex-US)
Investigational Drug: TRM-201 (rofecoxib); cyclooxygenase-2 (COX-2) selective NSAID
Administration: Oral, once daily
Primary Objective: To evaluate the efficacy of TRM-201 (rofecoxib) versus placebo in patients with hemophilic arthropathy as measured by patient assessment of average pain intensity.
Primary Efficacy Endpoint: Part I - The change from baseline in the daily average pain score averaged weekly for the most painful joint on a 0- to 10-point numeric rating scale. Additional endpoints will be evaluated in Part I and Part II including assessments of pain, physical function, and interference with sleep.

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