NCT00934544 is a Phase 3 clinical trial of Ruxolitinib in Myelofibrosis, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT00934544?

NCT00934544 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT00934544?

Interventions in NCT00934544: Ruxolitinib, Best Available Therapy (BAT).

What condition does NCT00934544 study?

NCT00934544 studies Myelofibrosis.

Is NCT00934544 still recruiting?

NCT00934544 is currently completed. Last updated 19 August 2019.

Are results published for NCT00934544?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-19 · How we verify

NCT00934544

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 19 August 2019

What this trial tests

Phase 3 trial testing Ruxolitinib in Myelofibrosis in 219 participants. Completed in 4 March 2015.

Timeline

1 July 2009

Primary endpoint
4 March 2015

4 March 2015

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	219
Start date	1 July 2009
Primary completion	4 March 2015
Estimated completion	4 March 2015
Sites	61 locations across France, Italy, Netherlands, Belgium, Austria, Sweden, United Kingdom, Germany

Drugs / interventions tested

Ruxolitinib (RUXOLITINIB) — full drug profile →
Best Available Therapy (BAT) — full drug profile →

Conditions studied

Myelofibrosis — all drugs for Myelofibrosis →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Myelofibrosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48 Primary · Baseline, Week 48

The change in spleen volume from baseline to week 48 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 48 was then calculated by treatment group.

Group	Value	95% CI
Ruxolitinib	28.5
Best Available Therapy (BAT)	0

Duration of Maintenance of Spleen Volume Reduction (Median) Secondary · Baseline, up to Year 5

DoMSR is defined as the interval between the first spleen volume measurement that is \>=35% reduction from baseline and the first scan that is no longer = 35% reduction AND that is a \>25% increase over nadir. It was evaluated using the Kaplan-Meier estimate for each treatment arm. The analysis was performed only for subjects who achieved greater than 35% reduction in spleen volume.

Group	Value	95% CI
Ruxolitinib	3.22	1.65 – NA
Best Available Therapy (BAT)	NA	NA – NA

Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates) Secondary · Baseline, up to Year 5

This is defined as the interval between randomization and date of the first MRI showing a 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume.

1.0 year

Group	Value	95% CI
Ruxolitinib	0.72	.60 – .81
Best Available Therapy (BAT)	NA	NA – NA

1.5 years

Group	Value	95% CI
Ruxolitinib	0.67	0.55 – 0.77
Best Available Therapy (BAT)	NA	NA – NA

2.0 years

Group	Value	95% CI
Ruxolitinib	0.63	0.50 – 0.73
Best Available Therapy (BAT)	NA	NA – NA

2.5 years

Group	Value	95% CI
Ruxolitinib	0.54	0.41 – 0.65
Best Available Therapy (BAT)	NA	NA – NA

3.0 years

Group	Value	95% CI
Ruxolitinib	0.51	0.38 – 0.62
Best Available Therapy (BAT)	NA	NA – NA

3.5 years

Group	Value	95% CI
Ruxolitinib	0.48	0.35 – 0.60
Best Available Therapy (BAT)	NA	NA – NA

4.0 years

Group	Value	95% CI
Ruxolitinib	0.48	0.35 – 0.60
Best Available Therapy (BAT)	NA	NA – NA

4.5 years

Group	Value	95% CI
Ruxolitinib	0.48	0.35 – 0.60
Best Available Therapy (BAT)	NA	NA – NA

Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24 Secondary · Baseline, Week 24

The change in spleen volume from baseline to week 24 was measured by magnetic resonance imaging (MRI) (or by computer tomography (CT) for participants unable to undergo MRI) and was calculated only for participants who had an evaluable spleen volume at baseline. The percentage of participants achieving a greater than or equal to 35% reduction in spleen volume from baseline to week 24 was then calculated by treatment group.

Group	Value	95% CI
Ruxolitinib	31.9
Best Available Therapy (BAT)	0

Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment (Primary Analysis) Secondary · Time from randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume

This is defined as the interval between randomization and date of the first MRI showing at least 35% reduction from baseline in spleen volume. The analysis was performed for participants who achieved a 35% reduction in spleen volume

12 weeks

Group	Value	95% CI
Ruxolitinib	0.23	0.14 – 0.34
Best Available Therapy (BAT)	0	NA – NA

24 weeks

Group	Value	95% CI
Ruxolitinib	0.67	0.54 – 0.76
Best Available Therapy (BAT)	1	NA – NA

36 weeks

Group	Value	95% CI
Ruxolitinib	0.87	0.76 – 0.93
Best Available Therapy (BAT)	1	NA – NA

48 weeks

Group	Value	95% CI
Ruxolitinib	0.97	0.89 – 0.99
Best Available Therapy (BAT)	1	NA – NA

Progression-free Survival (PFS) Secondary · Time from randomization and the earliest of either increase in spleen volume >=25% from on-study nadir, splenic irradiation, splenectomy, leukemic transformation or death

Median of time progression free survival (95% CI), years

Group	Value	95% CI
Ruxolitinib	1.6	1.2 – 2.3
Best Available Therapy (BAT)	1.4	1.1 – 1.9

Leukemia-free Survival (LFS) Secondary · Time from randomization and earliest of either leukemia or death

Time from randomization and earliest of either (1) date of bone marrow blast count of 20% or greater; (2) date of first peripheral blast count of 20% or greater that was subsequently confirmed to sustain for at least 8 weeks; (3) date of death from any cause

Group	Value	95% CI
Ruxolitinib	NA	NA – NA
Best Available Therapy (BAT)	4.1	2.4 – NA

Overall Survival (OS) Secondary · From randomization until death from any cause

Defined as the interval between randomization and the date of the bone marrow blast count of 20% or greater OR the date of the first peripheral blast count of 20% or greater that was subsequently confirmed to have been sustained for at least 8 weeks OR the date of death from any cause, whichever occurs first. OS was summarized using Kaplan-Meier estimates for each treatment arm. The estimates were supplemented by tables of number of events and probability estimates at several timepoints

Group	Value	95% CI
Ruxolitinib	NA	NA – NA
Best Available Therapy (BAT)	4.1	2.4 – NA

Percentage of Participants With Bone Marrow Histomorphology at Week 48 (Primary Analysis) Secondary · 48 weeks

This was noted as fibrosis density and was tabulated by fibrosis grade at baseline and at week 48 (post-baseline). Descriptive statistics (participant percentages) were used. Fibrosis grades: 0 Scattered linear reticulin with no intersections corresponding to normal bone marrow ; 1 Loose network of reticulin with many intersections, especially in perivascular areas; 2 Diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; 3 Diffuse and dense increase in reticulin with extensive intersections with coar

Grade 0

Group	Value	95% CI
Ruxolitinib	2.7
Best Available Therapy (BAT)	0.0

Grade 1

Group	Value	95% CI
Ruxolitinib	7.5
Best Available Therapy (BAT)	2.7

Grade 2

Group	Value	95% CI
Ruxolitinib	8.9
Best Available Therapy (BAT)	6.8

Grade 3

Group	Value	95% CI
Ruxolitinib	24.0
Best Available Therapy (BAT)	15.1

Missing Grade

Group	Value	95% CI
Ruxolitinib	56.8
Best Available Therapy (BAT)	75.3

Bone Marrow Histomorphology Secondary · Baseline, once a year

Shift table from baseline to last available postbaseline fibrosis grade by treatment The grade gives an indication of the activity or amount of inflammation and the stage represents the amount of fibrosis or scarring. The grade is assigned a number based on the degree of inflammation, which is usually scored from 0-4 with 0 being no activity and 3 or 4 considered severe activity

Postbaseline Grade 0

Group	Value	95% CI
Ruxolitinib	1	41.8 – 2.3
Ruxolitinib - Grade 1	1	47.9 – 1.9
Ruxolitinib - Grade 2	2
Ruxolitinib - Grade 3	1
Ruxolitinib - Missing	2
Best Available Therapy (BAT) - Grade 0	0
Best Available Therapy (BAT) - Grade 1	0
Best Available Therapy (BAT) - Grade 2	0
Best Available Therapy (BAT) - Grade 3	0
Best Available Therapy - Missing	0

Postbaseline Grade 1

Group	Value	95% CI
Ruxolitinib	0
Ruxolitinib - Grade 1	10
Ruxolitinib - Grade 2	9
Ruxolitinib - Grade 3	2
Ruxolitinib - Missing	0
Best Available Therapy (BAT) - Grade 0	0
Best Available Therapy (BAT) - Grade 1	1
Best Available Therapy (BAT) - Grade 2	0
Best Available Therapy (BAT) - Grade 3	1
Best Available Therapy - Missing	0

Postbaseline Grade 2

Group	Value	95% CI
Ruxolitinib	0
Ruxolitinib - Grade 1	2
Ruxolitinib - Grade 2	8
Ruxolitinib - Grade 3	8
Ruxolitinib - Missing	1
Best Available Therapy (BAT) - Grade 0	0
Best Available Therapy (BAT) - Grade 1	0
Best Available Therapy (BAT) - Grade 2	4
Best Available Therapy (BAT) - Grade 3	1
Best Available Therapy - Missing	0

Postbaseline Grade 3

Group	Value	95% CI
Ruxolitinib	0
Ruxolitinib - Grade 1	6
Ruxolitinib - Grade 2	19
Ruxolitinib - Grade 3	28
Ruxolitinib - Missing	2
Best Available Therapy (BAT) - Grade 0	0
Best Available Therapy (BAT) - Grade 1	0
Best Available Therapy (BAT) - Grade 2	4
Best Available Therapy (BAT) - Grade 3	8
Best Available Therapy - Missing	3

Postbaseline Missing

Group	Value	95% CI
Ruxolitinib	2
Ruxolitinib - Grade 1	2
Ruxolitinib - Grade 2	17
Ruxolitinib - Grade 3	20
Ruxolitinib - Missing	3
Best Available Therapy (BAT) - Grade 0	2
Best Available Therapy (BAT) - Grade 1	2
Best Available Therapy (BAT) - Grade 2	19
Best Available Therapy (BAT) - Grade 3	24
Best Available Therapy - Missing	4

Duration of Follow-up by Treatment Secondary · baseline, 260 weeks (end of study)

Number of Participants with duration of Follow up

<=1 year

Group	Value	95% CI
Ruxolitinib	16
Best Available Therapy (BAT)	15

>1 year - <=2 years

Group	Value	95% CI
Ruxolitinib	21
Best Available Therapy (BAT)	10

>2 years - <=3 years

Group	Value	95% CI
Ruxolitinib	9
Best Available Therapy (BAT)	13

>3 years - <=4 years

Group	Value	95% CI
Ruxolitinib	12
Best Available Therapy (BAT)	5

>4 years - <=5 years

Group	Value	95% CI
Ruxolitinib	27
Best Available Therapy (BAT)	8

5 years

Group	Value	95% CI
Ruxolitinib	61
Best Available Therapy (BAT)	22

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ruxolitinib Randomized

Serious: 51/146 (35%)

Deaths: —

Ruxolitinib Randomized + Extension Phase

Serious: 85/146 (58%)

Deaths: —

BAT Randomized

Serious: 22/73 (30%)

Deaths: —

Ruxolitinib Cross-over

Serious: 20/45 (44%)

Deaths: —

Serious adverse events (242 terms)

Reaction	System	Ruxolitinib Randomized	Ruxolitinib Randomized + E…	BAT Randomized	Ruxolitinib Cross-over
Pneumonia	Infections and infestations	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—
Varices oesophageal	Gastrointestinal disorders	—	—	—	—
General physical health deterioration	General disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—
Renal failure acute	Renal and urinary disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Infection	Infections and infestations	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—
Hyperuricaemia	Metabolism and nutrition disorders	—	—	—	—
Confusional state	Psychiatric disorders	—	—	—	—
Pancytopenia	Blood and lymphatic system disorders	—	—	—	—

Other adverse events (83 terms — click to expand)

Reaction	System	Ruxolitinib Randomized	Ruxolitinib Randomized + E…	BAT Randomized	Ruxolitinib Cross-over
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Asthenia	General disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Fatigue	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Weight increased	Investigations	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Haematoma	Vascular disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Skin lesion	Skin and subcutaneous tissue disorders	—	—	—	—

Most-reported serious reactions: Pneumonia, Anaemia, Abdominal pain, Cardiac failure, Pyrexia, Squamous cell carcinoma of skin, Thrombocytopenia, Atrial fibrillation.

Data from ClinicalTrials.gov NCT00934544 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis.
Harrison C, Kiladjian JJ, Al-Ali HK, Gisslinger H, et al · · 2012 · cited 1356× · PMID 22375970 · DOI 10.1056/nejmoa1110556
Philadelphia-negative classical myeloproliferative neoplasms: critical concepts and management recommendations from European LeukemiaNet.
Barbui T, Barosi G, Birgegard G, Cervantes F, et al · · 2011 · cited 570× · PMID 21205761 · DOI 10.1200/jco.2010.31.8436
Long-term findings from COMFORT-II, a phase 3 study of ruxolitinib vs best available therapy for myelofibrosis.
Harrison CN, Vannucchi AM, Kiladjian JJ, Al-Ali HK, et al · · 2016 · cited 363× · PMID 27211272 · DOI 10.1038/leu.2016.148
Signal Transducer and Activator of Transcription (STATs) Proteins in Cancer and Inflammation: Functions and Therapeutic Implication.
Loh CY, Arya A, Naema AF, Wong WF, et al · · 2019 · cited 241× · PMID 30847297 · DOI 10.3389/fonc.2019.00048
Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses.
Verstovsek S, Gotlib J, Mesa RA, Vannucchi AM, et al · · 2017 · cited 214× · PMID 28962635 · DOI 10.1186/s13045-017-0527-7
A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis.
Vannucchi AM, Kantarjian HM, Kiladjian JJ, Gotlib J, et al · · 2015 · cited 194× · PMID 26069290 · DOI 10.3324/haematol.2014.119545
Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I.
Verstovsek S, Mesa RA, Gotlib J, Levy RS, et al · · 2015 · cited 190× · PMID 25616577 · DOI 10.3324/haematol.2014.115840
Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I.
Verstovsek S, Mesa RA, Gotlib J, Levy RS, et al · · 2013 · cited 126× · PMID 24038026 · DOI 10.3324/haematol.2013.092155

Verify or expand the search:

Other trials of Ruxolitinib

Trials testing the same drug.

NCT07498205 — Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts · Phase 4 · not yet recruiting
NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
NCT07311746 — Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07340138 — Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis · Phase 1 · not yet recruiting
NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting

Other recruiting trials for Myelofibrosis

Currently open trials in the same condition.

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NCT07342712 — Clinical Trail to Evaluate the Effect of Long-term Treatment With Gecacitinib on Myelofibrosis and Gene Mutation Levels · active not recruiting
NCT06533813 — Clinical Epidemiology in Contemporary Patients With Myelofibrosis. · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

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NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00934544 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 19 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00934544.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00934544

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (242 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Ruxolitinib

Other recruiting trials for Myelofibrosis

Other Novartis Pharmaceuticals trials

Verify against primary sources