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MF
PV
  1. Study Design
  2. COMFORT-1

JAKAVI was studied in the most comprehensive clinical trial program in myelofibrosis to date1,2

COMFORT-I: Randomised, double-blind, placebo-controlled Phase III study1,3

JAK2 Inhibitor for Myelofibrosis COMFORT-I study design - JAKAVI

Primary endpoint: Proportion of patients achieving a ≥35% reduction in spleen volume from baseline at Week 24 (as measured by magnetic resonance imaging [MRI] or computed tomography [CT] scan).

Secondary endpoints:

  • Duration of maintenance of a ≥35% reduction from baseline in spleen volume
  • Proportion of patients who had ≥50% reduction from baseline at Week 24 in TSS as measured by the modified MFSAF diary, version 2.0
  • Change from baseline to Week 24 in TSS as measured by the modified MFSAF diary, version 2.0
  • Overall survival

Next: COMFORT-II study design

BID=twice daily; COMFORT=Controlled Myelofibrosis Study with Oral JAK Inhibitor; CT=computed tomography; MF=myelofibrosis; MFSAF=Myelofibrosis Symptom Assessment Form; MRI=magnetic resonance imaging; TSS=total symptom score.

References:

  1. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366(9):799-807.
  2. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012;366(9):787-798.
  3. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis [Protocol]. N Engl J Med. 2012;366(9):799-807. doi:10.1056/NEJMoa1110557.