Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial

Sponsor
Novartis Pharmaceuticals
Study ID
NCT00934544
Phase
PHASE3
Status
Completed

Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    5 mg tablets packaged as 60-count in high-density polyethylene bottles
  • Best Available Therapy (BAT) — DRUG
    Prescribing and usage per respective package inserts

Study Details

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).

Key Dates

Start date
Jul 1, 2009
Status verified
Jul 2019
Primary completion
Mar 4, 2015
Completion
Mar 4, 2015

Study Design

Enrollment
219 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib
    5 mg tablets administered orally in an outpatient setting according to the protocol-specified dosing schedule
  • Active Comparator: Best Available Therapy (BAT)
    Commercially available therapy, oral or parenteral, per manufacturer's instructions and Investigator discretion. BAT included the option of no treatment. Patients randomized to BAT were eligible to cross over to receive open-label ruxolitinib after a qualifying progression event, if they met the safety criteria. After the primary analysis in January 2011, patients randomized to receive BAT were allowed to cross over to receive ruxolitinib and move to the extension phase of the study without a qualifying progression event.

Primary Outcome Measure

Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48 [ Time Frame: Baseline, Week 48 ]

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