At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 219 enrolled

Drug / intervention

Ruxolitinib +1 moredrug

Likely dose

Ruxolitinib 5 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00934544

NCT00934544Phase 3Completed

Compare CT.gov

A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

Novartis Pharmaceuticals·interventional·Posted Jul 8, 2009·Updated Aug 19, 2019

In Brief

A Phase 3 clinical trial evaluating Ruxolitinib and Best Available Therapy (BAT) for Myelofibrosis. Completed, enrolled 219 participants across 61 sites in 9 countries.

Detailed Summary

This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMyelofibrosis

CountriesAustria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom

Collaborators--

Timeline

Phase 3CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartJul 2009

First PostedJul 2009

Primary CompletionMar 2015

TodayJul 2026

First PostedJul 8, 2009

Enrollment StartJul 1, 2009

Primary CompletionMar 4, 2015

TodayJul 2, 2026

Enrollment to primary: 5.7 yearsPosted 17.0 years ago

Interventions

Ruxolitinibdrug

5 mg tablets packaged as 60-count in high-density polyethylene bottles

Best Available Therapy (BAT)drug

Prescribing and usage per respective package inserts