Trial · NCT00952289
COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
NCT00952289, Phase 3, Completed, Incyte Corporation; results first posted 2012-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial. Trials, record NCT00952289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00952289
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
- NCT number
- NCT00952289
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 309 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- MPN (Myeloproliferative Neoplasms)
- Interventions
- Ruxolitinib, Placebo
- First posted
- 2009-08-06
- Last updated
- 2018-03-12
- Results first posted
- 2012-01-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 | Baseline and Week 24 | 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. |
| Secondary | Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib | Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months). | The maintenance of ≥ 35% reduction from Baseline in spleen volume was assessed up until the data cutoff date using the Kaplan-Meier method for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or who subsequently dropped out prior to another assessment. |
| Secondary | Duration of Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib | Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months). | The duration of ≥ 35% reduction from Baseline in spleen volume was defined as the longest duration of consecutive measurements of ≥ 35% reduction observed before the data cut-off date for patients who had at least one measured ≥ 35% reduction, and who either had at least one subsequent measurement or, who subsequently dropped out prior to another assessment. The duration of a ≥ 35% reduction from Baseline in spleen volume was analyzed using the Kaplan-Meier method. |
| Secondary | Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24 | Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit. | Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms. |
| Secondary | Change From Baseline to Week 24 in Total Symptom Score | Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit. | Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms hence a negative change from baseline indicates improvement. |
| Secondary | Overall Survival | From randomization to the data cut-off date (up to 14 months). | Overall survival is reported here by the number of deaths from randomization until the data cut-off. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. |
| Secondary | Overall Survival Time | From randomization to the data cut-off date (up to 14 months). | Overall survival was assessed by the time to death or censoring. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. |
| Secondary | Overall Survival - Extended Data | From randomization to 4 months after the data cut-off date (up to 18 months). | Overall survival is reported here by the number of deaths from randomization until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update. |
| Secondary | Overall Survival Time - Extended Data | From randomization to 4 months after the data cut-off date (up to 18 months). | Overall survival was assessed by the time to death or censoring up until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update. |
| Secondary | Overall Survival at Week 144 | Week 144 | Overall survival is reported here by the number of deaths from randomization until the data cut-off. Patients were censored at the time of database cut-off or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of database cut-off. The survival time was analyzed using the Kaplan-Meier method. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 | Baseline and Week 24 | Intent-to-treat (ITT) population included all subjects randomized in the study. Treatment groups for this population were defined according to the treatment assignment at randomization. One patient was not included in the analysis due to a missing baseline spleen volume value. | participants | NUMBER |
| SECONDARY | Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib | Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months). | Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment. | proportion of participants | NUMBER |
| SECONDARY | Duration of Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib | Baseline Visit and every 12 weeks until the data cut-off date (up to 14 months). | Patients who had at least 1 measurement of ≥ 35% reduction from Baseline in spleen volume at any time during the study and had at least 1 subsequent measurement or withdrew prior to another assessment. | weeks | MEDIAN |
| SECONDARY | Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24 | Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit. | ITT evaluable population included patients with Baseline data and who did not have a 0 total score at both Baseline \& Week 24; data measured after the cross over date were excluded. Patients who withdrew, met cross over criteria prior to Week 24 or had a 0 Baseline score \& a nonzero/missing score at Week 24 were considered not meeting the endpoint. | participants | NUMBER |
| SECONDARY | Change From Baseline to Week 24 in Total Symptom Score | Baseline and Week 24. Baseline total score was the average of the daily total scores for the last 7 days prior to randomization. The Week 24 total score was the average of daily total scores from the 28 days prior to the Week 24 visit. | This analysis only includes patients who had a non-missing change from Baseline to Week 24. Data collected after the date of treatment cross over were not included in this analysis. | scores on a scale | MEAN |
| SECONDARY | Overall Survival | From randomization to the data cut-off date (up to 14 months). | ITT population | participants | NUMBER |
| SECONDARY | Overall Survival Time | From randomization to the data cut-off date (up to 14 months). | ITT population | weeks | MEDIAN |
| SECONDARY | Overall Survival - Extended Data | From randomization to 4 months after the data cut-off date (up to 18 months). | ITT population | participants | NUMBER |
| SECONDARY | Overall Survival Time - Extended Data | From randomization to 4 months after the data cut-off date (up to 18 months). | ITT population | weeks | MEDIAN |
| SECONDARY | Overall Survival at Week 144 | Week 144 | ITT population | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 | Ruxolitinib | 65 | participants | ||
| Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 | Placebo | 1 | participants | ||
| Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib | Ruxolitinib | Still Responder by 48 weeks | 0.76 | 95% Confidence Interval 0.66 to 0.84 | proportion of participants |
| Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib | Ruxolitinib | Still Responder by 96 weeks | 0.67 | 95% Confidence Interval 0.55 to 0.76 | proportion of participants |
| Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib | Ruxolitinib | Still Responder by 144 weeks | 0.27 | 95% Confidence Interval 0.02 to 0.63 | proportion of participants |
| Duration of Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib | Ruxolitinib | 135.0 | 95% Confidence Interval 107.6 to NA | weeks | |
| Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24 | Ruxolitinib | 68 | participants | ||
| Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24 | Placebo | 8 | participants | ||
| Change From Baseline to Week 24 in Total Symptom Score | Ruxolitinib | Baseline | 18.0 | Standard Deviation 10.9 | scores on a scale |
| Change From Baseline to Week 24 in Total Symptom Score | Placebo | Baseline | 16.5 | Standard Deviation 11.5 | scores on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| All Participants | STARTED | Ruxolitinib | 155 | |
| All Participants | STARTED | Placebo | 154 | |
| All Participants | Safety Population | Ruxolitinib | 155 | |
| All Participants | Safety Population | Placebo | 151 | |
| All Participants | COMPLETED | Ruxolitinib | 134 | |
| All Participants | COMPLETED | Placebo | 114 | |
| All Participants | NOT COMPLETED | Ruxolitinib | 21 | |
| All Participants | NOT COMPLETED | Placebo | 40 | |
| Patients Who Crossed Over to Ruxolitinib | STARTED | Ruxolitinib | 0 | |
| Patients Who Crossed Over to Ruxolitinib | STARTED | Placebo | 111 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events318
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ruxolitinib | 52 | 155 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 14 | 151 | |
| other | Anaemia | Blood and lymphatic system disorders | Ruxolitinib | 45 | 155 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 20 | 151 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Ruxolitinib | 1 | 155 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 8 | 151 | |
| other | Abdominal pain | Gastrointestinal disorders | Ruxolitinib | 16 | 155 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 58 | 151 | |
| other | Diarrhoea | Gastrointestinal disorders | Ruxolitinib | 36 | 155 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 32 | 151 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruxolitinib | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ruxolitinib | 150 | 155 |
| Total, other adverse events | Placebo | 147 | 151 |
| Total, serious adverse events | Ruxolitinib | 43 | 155 |
| Total, serious adverse events | Placebo | 53 | 151 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ruxolitinib vs Placebo: Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24 | Trial comparisons |
| Ruxolitinib vs Placebo: Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 | Trial comparisons |
| Ruxolitinib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00952289
GET https://conductscience.org/api/trials/v1/NCT00952289/results?page=2