Study Design

This is a prospective randomized, double-blind, placebo-controlled, parallel-group study in patients with hemophilic arthropathy. Part I of the study will evaluate TRM-201 (rofecoxib) and placebo over a 12-week treatment period, and Part II is an active open-label extension.

Patients will be screened to determine eligibility and will be then included in a washout period of at least 7 days prior to randomization.

During the washout period, patients will be allowed to treat with acetaminophen/paracetamol 500 mg/dose up to 2000 mg /day and will record their average pain once daily in an e-diary.

Patients who meet randomization criteria, all of the study inclusion criteria, and none of the exclusion criteria will be randomized in a 1:1 ratio into Part I of the study to one of two treatment arms: TRM-201 (rofecoxib) once daily or matching placebo once daily for 12 weeks.

At the end of 12 weeks, patients randomized to the rofecoxib arm will remain in that treatment arm and patients randomized to placebo will receive rofecoxib once daily for up to 12 additional months (Part II).

The total maximum time on study (including the screening period) is 16 weeks for the Part I and 52 weeks for Part II for a total of 68 weeks. The anticipated total number of visits is 11.

We Look Forward to Speaking to You

If you would like more information about the RESET-HA study, including how to refer a patient or to be considered as a principal investigator, please fill out our form below.

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