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NCT00952289 · ClinicalTrials.gov registry record · Phase 3
COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
A Phase 3 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 309
- Enrollment target
NCT00952289: Completed Phase 3 study, sponsored by Incyte Corporation.
NCT00952289 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 309 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00952289, a Phase 3 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 309 participants
- Enrollment target
Study Summary
This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).
Primary Outcome
Spleen volume was assessed by magnetic resonance imaging (MRI) or by computed tomography (CT) scans if MRI was not suitable, and analyzed by a blinded central laboratory reader. Patients who withdrew, crossed over to ruxolitinib prior to the visit, or had a missing value at the visit were considered non-responders.
Interventions
- DRUG Placebo
- DRUG Ruxolitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2009-08 |
| Est. Completion | 2015-10 |
| Phase | Phase 3 |
What the finished NCT00952289 record still lists
NCT00952289 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00952289 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00952289 about?
NCT00952289 is a clinical study titled "COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial". This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia ...
What is the current status of trial NCT00952289?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2009-08. Estimated completion is 2015-10.
What interventions are being tested in trial NCT00952289?
The interventions under investigation include: Placebo (DRUG), Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT00952289?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00952289's enrollment target sits among peer trials
309 1109th of 2000 higher than 889 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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