Myelofibrosis With High Molecular Risk Mutations
Conditions
Keywords
Early Myelofibrosis, high molecular risk mutations., Ruxolitinib, INC424, High molecular risk mutations, HMR
Brief summary
Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.
Interventions
DRUGRuxolitinib
5 mg tablet for oral use
DRUGRuxolitinib Placebo
5 mg placebo tablet for oral use
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of MF with bone marrow fibrosis of at least Grade 1; irrespective of JAK2 mutational status * Patients with at least one mutation in one of the five HMR genes (ASXL1, EZH2, SRSF2 and IDH1/2) * Patients with non-palpable spleen or spleen palpable ≤ 5 cm from the left costal margin to the point of greatest splenic protrusion * Patients with MF-7 score of ≤ 15, with each individual symptom score of ≤ 3
Exclusion criteria
* Patients with prior treatment with ruxolitinib or other JAK inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS-1) | From randomization till disease progression (estimated to be assessed up 48 months) | Progression free survival (PFS-1) from date of randomization until the occurrence of any of the criteria for disease progression: * Progressive splenomegaly * Circulating peripheral blast counts \> 10% * Leukemic transformation * Hb \< 10g/dl with absolute decrease of at least 3 g/dl from baseline * White blood cell (WBC) counts \> 25 x 103/ μL * MF-7 score ≥ 30 * Death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Spleen Volume From Baseline | From baseline and assessed on 12 week intervals until end of treatment (EOT) | Change in spleen volume (by MRI/CT) from baseline |
| Percentage Change in Symptoms From Baseline Using MF-7 | From Baseline and assessed every 4 weeks until end of treatment | Percentage change from Baseline in MF-7 total symptom score and 7 individual symptoms at each visit was summarized with descriptive statistics. For this scale, symptoms range from 0 to 10 for the severity experienced within the past 24 hours, with 0 being for absence of symptoms and 10 for worst imaginable symptoms. |
| Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | From Baseline and assessed every 4 weeks until end of treatment | EQ-ED5 profiles were summarized at baseline and at each scheduled assessment for each of the 5 dimensions separately (Mobility, self-care, usual activities, pain discomfort, anxiety/depression) Only participants with baseline score and at least one non-missing post-baseline score during the treatment period were included. Percentages were based on all these evaluable participants. The 5 scores for mobility, self-care, usual activities, pain/discomfort and anxiety/depression are all self-explanatory (eg I have no problems walking to I am unable to walk), except for the following overall health check, where 100 is the best of health, and 0 is the worst health. |
| Overall Survival | Time from randomization to date of death due to any cause (estimated to be assessed up to 48 months). | To evaluate the effect of ruxolitinib on overall survival |
| Time to Primary Progression (TTP) | From randomization till progression (estimated to be assessed up to 48 months) | TTP is defined as time from randomization until disease progression as defined for PFS-1 excluding death as an event. |
| Progression Free Survival (PFS-2) | From date of randomization until second disease progression or death, whichever comes first (estimated to be assessed up to 72 months) | PFS-2 assessed by 25% increase over new baseline of PFS-1 in any of the following: ● Progressive splenomegaly ● 25 % increase in MF-7 score with absolute score ≥ 30 |
| Quality-adjusted Life Years From Baseline | Change from Baseline compared with scheduled study visits at the following intervals every 4 weeks up to week 24, every 8 weeks up to Week 48, every 12 weeks past Wk 48 until End of treatment and 30 day follow up visit | EQ-5D-5L (EuroQol-5D-5L, is a standardized instrument for measuring health outcomes, is consists of a descriptive system and a visual analogue scale - scores can be summarized into a single index score that provides a simple measure of health for clinical and economic appraisal ) The EQ-5D-5L health states will be converted into index values (utilities) from which the QALY (Quality - adjusted life years) will be calculated. QALY will be summarized descriptively by treatment arm. |
| Time to First Progressive Splenomegaly (TTPS) | From randomization until earliest time to progressive splenomegaly (estimated to be assessed up to 48 months) | Time to first progressive splenomegaly as determined by spleen volume (by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT). |
| Time to First Symptomatic Progression (TTSP) | From randomization until symptomatic progression (MF-7)(estimated to be assessed up to 48 months) | Time to first symptomatic progression as determined by Myelofibrosis 7 Item Symptom Scale (MF-7) |
| Plasma Ruxolitinib Concentrations | Week 12, Wk 48 | Characterize pharmacokinetics (PK)by utilizing a population PK approach. |
Countries
Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Participant flow
Recruitment details
Approximately 320 male or female adults (age 18 or over) with a confirmed diagnosis of MF were planned to be enrolled. The target population was not met due to early study termination. A total of 49 subjects were enrolled in the study, 25 in the ruxolitinib arm and 24 in the placebo arm.
Participants by arm
| Arm | Count |
|---|---|
| Ruxolitinib (INC424) Two tablets of ruxolitinib 5 mg were administered orally twice per day | 25 |
| Ruxolitinib Placebo Two tablets of 5mg placebo were administered orally twice per day | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Followed for survival | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Study terminated by Sponsor | 21 | 23 |
| Overall Study | Subject/guardian decision | 1 | 0 |
Baseline characteristics
| Characteristic | Ruxolitinib (INC424) | Ruxolitinib Placebo | Total |
|---|---|---|---|
| Age, Continuous | 59.0 Years STANDARD_DEVIATION 14.23 | 67.4 Years STANDARD_DEVIATION 7.72 | 63.1 Years STANDARD_DEVIATION 12.17 |
| Race/Ethnicity, Customized Asian | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Caucasian | 19 Participants | 23 Participants | 42 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 12 Participants | 7 Participants | 19 Participants |
| Sex: Female, Male Male | 13 Participants | 17 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 17 / 24 | 11 / 24 |
| serious Total, serious adverse events | 2 / 24 | 1 / 24 |
Outcome results
Primary
Progression Free Survival (PFS-1)
Progression free survival (PFS-1) from date of randomization until the occurrence of any of the criteria for disease progression: * Progressive splenomegaly * Circulating peripheral blast counts \> 10% * Leukemic transformation * Hb \< 10g/dl with absolute decrease of at least 3 g/dl from baseline * White blood cell (WBC) counts \> 25 x 103/ μL * MF-7 score ≥ 30 * Death from any cause
Time frame: From randomization till disease progression (estimated to be assessed up 48 months)
Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that the primary endpoint of PFS and any other time to event endpoint would not be derived.
Secondary
Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D
EQ-ED5 profiles were summarized at baseline and at each scheduled assessment for each of the 5 dimensions separately (Mobility, self-care, usual activities, pain discomfort, anxiety/depression) Only participants with baseline score and at least one non-missing post-baseline score during the treatment period were included. Percentages were based on all these evaluable participants. The 5 scores for mobility, self-care, usual activities, pain/discomfort and anxiety/depression are all self-explanatory (eg I have no problems walking to I am unable to walk), except for the following overall health check, where 100 is the best of health, and 0 is the worst health.
Time frame: From Baseline and assessed every 4 weeks until end of treatment
Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. Only the categories with non-zero counts are presented with these results. Only subjects with baseline score and at least one non-missing post-baseline score during the treatment period 1 were included. % is based on all these evaluable subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 4: No problem | 21 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 20: No problem | 13 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 4: Slight problems | 4 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 20: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 4: Slight problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 24: No problem | 12 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 24: Moderate problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 24: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 4: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 32: No problem | 8 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 12: No problem | 15 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 32: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 8: No problem | 19 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 40: No problem | 5 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 32: No problem | 8 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 40: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 8: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 48: No problem | 3 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- Baseline: Extreme problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - EOT: No problem | 12 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 12: No problem | 17 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities -EOT: Slight problems | 3 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 32: Slight problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - 30 day Safety FU: No problem | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 12: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - 30 say Safety FU: Slight probs | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 12: Slight problems | 4 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Baseline: No problem | 13 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 12: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Baseline: Slight problems | 8 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 32: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Baseline: Moderate problems | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 16: No problem | 15 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 4: No problem | 11 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 4: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 4: Slight problems | 10 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 16: Slight problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 4: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 40: No problem | 5 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 8: No problem | 14 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 20: No problem | 14 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 8: Slight problems | 5 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 8: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 12: Moderate problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 12: No problem | 12 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 24: No problem | 12 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 12: Slight problems | 7 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 40: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 12: Moderate problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 24: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 16: No problem | 9 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- Baseline: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK16: Slight problems | 6 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 32: No problem | 8 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK16: Moderate problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK20: No problem | 8 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 48: No problem | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK20: Slight problems | 6 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 32: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK24: No problem | 9 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 16: No problem | 12 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK24: Slight problems | 4 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 40: No problem | 5 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK32: No problem | 7 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 48: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK32: Slight problems | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 40: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK40: No problem | 4 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 16: Slight problems | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK40: Slight problems | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 48: No problem | 3 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK48: No problem | 3 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - EOT: No problem | 11 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - EOT: No problem | 8 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - EOT: No problem | 14 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - EOT: Slight problems | 7 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 8: No problem | 17 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - EOT: Moderate problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - EOT: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - 30 day Safety FU: No problem | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - EOT: Slight problems | 4 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - 30 day safety FU: Slight probs | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - 30 day Safety FU: No problem | 3 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - 30 day Safety FU: Moderate probs | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 16: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - Baseline: No problem | 14 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities -Baseline: No problem | 18 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - Baseline: Slight problems | 6 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - EOT: Moderate problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - Baseline: Moderate problems | 3 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities -Baseline: Slight problems | 4 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK4: No problem | 13 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 4:No prob. | 17 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK4: Slight problems | 7 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Baseline: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK4: Moderate problems | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- 30 day safety FU: No problem | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK8: No problem | 11 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 4: No problem | 20 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK8: Slight problems | 8 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 20: No problem | 12 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK8: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 4: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK12: No problem | 8 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 8: Slight problems | 3 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 4: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression -WK12: Moderate problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 20: Slight problems | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK16: No problem | 10 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 4: Severe problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK16: Slight problems | 5 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK12: Slight problems | 10 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK16: Moderate problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 8: No problem | 20 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression -WK20: No problem | 10 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- Baseline: Slight problems | 4 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK20: Slight problems | 4 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 8: Slight problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK24: No problem | 11 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- 30 day safety FU: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK24: Slight problems | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 8: Moderate problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK32: No problem | 7 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 24: No problem | 12 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK32: Slight problems | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 12: No problem | 16 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK40: No problem | 5 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Baseline: No problem | 23 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK40: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 12: Slight problems | 3 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK48: No problem | 3 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 8: Moderate problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - EOT: No problem | 11 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 12: Moderate problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - EOT: Slight probs | 4 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Baseline: Slight problems | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - EOT: Moderate probs | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 16: No problem | 13 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - 30 day Safety FU: No probs | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 24: Slight problems | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression-30 day Safety FU: Slight probs | 1 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 16: Slight problems | 2 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression-30 day Safety FU: Severe probs | 0 Participants |
| Ruxolitinib (INC424) | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- Baseline: No problem | 17 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression-30 day Safety FU: Severe probs | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- Baseline: No problem | 18 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- Baseline: Slight problems | 5 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- Baseline: Moderate problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- Baseline: Extreme problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 4:No prob. | 14 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 4: Slight problems | 7 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 4: Moderate problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 8: No problem | 15 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 8: Slight problems | 6 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 8: Moderate problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 12: No problem | 12 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 12: Slight problems | 6 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 12: Moderate problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 16: Slight problems | 7 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 16: Moderate problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 20: No problem | 5 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 20: Slight problems | 6 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 24: No problem | 5 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 24: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 24: Moderate problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 32: No problem | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 32: Slight problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 32: Moderate problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 40: No problem | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 40: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 48: No problem | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 48: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - EOT: No problem | 12 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - EOT: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - EOT: Moderate problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility - Week 16: No problem | 10 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 8: Slight problems | 7 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK16: Moderate problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- 30 day safety FU: No problem | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Mobility- 30 day safety FU: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Baseline: No problem | 22 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Baseline: Slight problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 4: No problem | 20 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 4: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 4: Moderate problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 8: No problem | 21 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 8: Slight problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 12: No problem | 19 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 12: Slight problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 12: Moderate problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 16: No problem | 16 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 16: Slight problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 20: No problem | 11 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 24: No problem | 9 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 24: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 32: No problem | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 32: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 40: No problem | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 40: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - Week 48: No problem | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - EOT: No problem | 15 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - EOT: Slight problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Self-care - 30 day Safety FU: No problem | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities -Baseline: No problem | 21 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities -Baseline: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Baseline: Moderate problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 4: No problem | 18 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 4: Slight problems | 4 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 4: Moderate problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 4: Severe problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 8: No problem | 18 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 8: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 8: Moderate problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 12: No problem | 16 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 12: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 12: Moderate problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 16: No problem | 14 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 16: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 20: No problem | 9 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 20: Slight problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 24: No problem | 9 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 24: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 32: No problem | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 32: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 40: No problem | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 40: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - Week 48: No problem | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - EOT: No problem | 13 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities -EOT: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - 30 day Safety FU: No problem | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Usual activities - 30 say Safety FU: Slight probs | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Baseline: No problem | 11 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Baseline: Slight problems | 12 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Baseline: Moderate problems | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 4: No problem | 15 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 4: Slight problems | 6 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 4: Moderate problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 8: No problem | 13 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 8: Moderate problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 12: No problem | 10 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 12: Slight problems | 6 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 12: Moderate problems | 4 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - Week 16: No problem | 11 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK16: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK20: No problem | 8 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK20: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK24: No problem | 7 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK24: Slight problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK32: No problem | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK32: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK40: No problem | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK40: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - WK48: No problem | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - EOT: No problem | 10 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - EOT: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - EOT: Moderate problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - 30 day Safety FU: No problem | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - 30 day safety FU: Slight probs | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Pain/Discomfort - 30 day Safety FU: Moderate probs | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - Baseline: No problem | 18 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - Baseline: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - Baseline: Moderate problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK4: No problem | 15 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK4: Slight problems | 6 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK4: Moderate problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK8: No problem | 16 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK8: Slight problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK8: Moderate problems | 4 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK12: No problem | 13 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK12: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression -WK12: Moderate problems | 4 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK16: No problem | 10 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK16: Slight problems | 5 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK16: Moderate problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression -WK20: No problem | 8 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK20: Slight problems | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK24: No problem | 7 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK24: Slight problems | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK32: No problem | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK32: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK40: No problem | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK40: Slight problems | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - WK48: No problem | 0 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - EOT: No problem | 12 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - EOT: Slight probs | 3 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - EOT: Moderate probs | 1 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression - 30 day Safety FU: No probs | 2 Participants |
| Ruxolitinib Placebo | Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D | Anxiety/Depression-30 day Safety FU: Slight probs | 0 Participants |
Secondary
Overall Survival
To evaluate the effect of ruxolitinib on overall survival
Time frame: Time from randomization to date of death due to any cause (estimated to be assessed up to 48 months).
Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived.
Secondary
Percentage Change in Spleen Volume From Baseline
Change in spleen volume (by MRI/CT) from baseline
Time frame: From baseline and assessed on 12 week intervals until end of treatment (EOT)
Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib (INC424) | Percentage Change in Spleen Volume From Baseline | Week 12 | -10.8 Percentage change from baseline | Standard Deviation 24.45 |
| Ruxolitinib (INC424) | Percentage Change in Spleen Volume From Baseline | Week 24 | -17.8 Percentage change from baseline | Standard Deviation 18.83 |
| Ruxolitinib (INC424) | Percentage Change in Spleen Volume From Baseline | Week 36 | -18.4 Percentage change from baseline | Standard Deviation 31.62 |
| Ruxolitinib (INC424) | Percentage Change in Spleen Volume From Baseline | Week 48 | -23.5 Percentage change from baseline | Standard Deviation 10.57 |
| Ruxolitinib (INC424) | Percentage Change in Spleen Volume From Baseline | End of Treatment (EOT) | -11.6 Percentage change from baseline | Standard Deviation 8.08 |
| Ruxolitinib Placebo | Percentage Change in Spleen Volume From Baseline | Week 12 | 9.1 Percentage change from baseline | Standard Deviation 12.34 |
| Ruxolitinib Placebo | Percentage Change in Spleen Volume From Baseline | Week 36 | 32.5 Percentage change from baseline | Standard Deviation 18.81 |
| Ruxolitinib Placebo | Percentage Change in Spleen Volume From Baseline | Week 24 | 17.6 Percentage change from baseline | Standard Deviation 17.78 |
| Ruxolitinib Placebo | Percentage Change in Spleen Volume From Baseline | End of Treatment (EOT) | 18.1 Percentage change from baseline | Standard Deviation 18.58 |
Secondary
Percentage Change in Symptoms From Baseline Using MF-7
Percentage change from Baseline in MF-7 total symptom score and 7 individual symptoms at each visit was summarized with descriptive statistics. For this scale, symptoms range from 0 to 10 for the severity experienced within the past 24 hours, with 0 being for absence of symptoms and 10 for worst imaginable symptoms.
Time frame: From Baseline and assessed every 4 weeks until end of treatment
Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | AD: change from BL @ EOT | 0.1 Percentage change in scores | Standard Deviation 0.92 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | TSD change from baseline @ W12 | -0.3 Percentage change in scores | Standard Deviation 4.45 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Night sweat (NS): Baseline (BL) | 0.7 Percentage change in scores | Standard Deviation 1.07 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Tiredness: change from baseline @ W24 | -0.1 Percentage change in scores | Standard Deviation 0.76 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Night sweat change from BL @W12 | -0.1 Percentage change in scores | Standard Deviation 0.71 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | PUROLS: change from BL @W48 | 0.0 Percentage change in scores | Standard Deviation 0 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Night sweat change from BL @W24 | 0.5 Percentage change in scores | Standard Deviation 1.45 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Tiredness: change from baseline @ W48 | -0.3 Percentage change in scores | Standard Deviation 0.58 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Night sweat change from BL @W48 | -0.3 Percentage change in scores | Standard Deviation 0.58 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Night Sweat: change from BL @ EOT | 0.0 Percentage change in scores | Standard Deviation 0.85 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Tiredness change from BL @ EOT | 0.8 Percentage change in scores | Standard Deviation 1.32 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Itching (Pruritus):BL | 0.9 Percentage change in scores | Standard Deviation 1.42 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | TSD change from baseline @ W24 | 0.5 Percentage change in scores | Standard Deviation 3.71 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Itching (Pruritus): change from BL @W12 | -0.3 Percentage change in scores | Standard Deviation 0.67 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Filling up quickly when you eat (FUQWYE):BL | 1.0 Percentage change in scores | Standard Deviation 1.41 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Itching (Pruritus): change from BL @W24 | 0.4 Percentage change in scores | Standard Deviation 0.77 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | PUROLS: change from BL @W24 | 0.0 Percentage change in scores | Standard Deviation 0.41 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Itching (Pruritus): change from BL @W48 | -1.0 Percentage change in scores | Standard Deviation 1.73 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Itching: change from BL @ EOT | 0.1 Percentage change in scores | Standard Deviation 1.03 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | TSD change from baseline @ W48 | -0.3 Percentage change in scores | Standard Deviation 3.06 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Bone Pain: BL | 0.9 Percentage change in scores | Standard Deviation 1.35 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | FUQWYE: change from BL @W12 | 0.1 Percentage change in scores | Standard Deviation 1.49 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Bone Pain: change from BL @W12 | -0.4 Percentage change in scores | Standard Deviation 1.01 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | FUQWYE: change from BL @W24 | -0.2 Percentage change in scores | Standard Deviation 0.99 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Bone Pain: change from BL @W24 | -0.2 Percentage change in scores | Standard Deviation 1.17 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | TSD change from BL @ EOT | 1.1 Percentage change in scores | Standard Deviation 4.4 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Bone Pain: change from BL @W48 | 0.7 Percentage change in scores | Standard Deviation 1.15 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Bone Pain: change from BL @ EOT | 0.1 Percentage change in scores | Standard Deviation 0.96 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | FUQWYE: change from BL @W48 | 0.7 Percentage change in scores | Standard Deviation 1.15 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Pain under ribs on left side (PUROLS): BL | 0.7 Percentage change in scores | Standard Deviation 1.18 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | FUQWYE: change from BL @ EOT | 0.2 Percentage change in scores | Standard Deviation 1.08 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | PUROLS: change from BL @W12 | 0.4 Percentage change in scores | Standard Deviation 1.01 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Total Score derived (TSD): Baseline (BL) | 6.6 Percentage change in scores | Standard Deviation 5.17 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Abdominal discomfort (AD): BL | 0.7 Percentage change in scores | Standard Deviation 1.43 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Tiredness: Baseline (BL) | 1.8 Percentage change in scores | Standard Deviation 1.45 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Abdominal discomfort change from BL @W12 | -0.1 Percentage change in scores | Standard Deviation 1.66 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | PUROLS: change from BL @ EOT | -0.2 Percentage change in scores | Standard Deviation 0.68 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Abdominal discomfort change from BL @W24 | 0.0 Percentage change in scores | Standard Deviation 1.15 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Tiredness: change from baseline @ W12 | 0.1 Percentage change in scores | Standard Deviation 1.47 |
| Ruxolitinib (INC424) | Percentage Change in Symptoms From Baseline Using MF-7 | Abdominal discomfort change from BL @W48 | 0.0 Percentage change in scores | Standard Deviation 0 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Night sweat change from BL @W12 | -0.3 Percentage change in scores | Standard Deviation 1.29 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | PUROLS: change from BL @W24 | 0.1 Percentage change in scores | Standard Deviation 1.17 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | PUROLS: change from BL @ EOT | 0.3 Percentage change in scores | Standard Deviation 1 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Total Score derived (TSD): Baseline (BL) | 5.9 Percentage change in scores | Standard Deviation 5.56 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | TSD change from baseline @ W12 | 0.5 Percentage change in scores | Standard Deviation 6.08 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | TSD change from baseline @ W24 | -0.8 Percentage change in scores | Standard Deviation 6.44 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | TSD change from BL @ EOT | 3.3 Percentage change in scores | Standard Deviation 9.53 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Tiredness: Baseline (BL) | 1.5 Percentage change in scores | Standard Deviation 1.53 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Tiredness: change from baseline @ W12 | 0.4 Percentage change in scores | Standard Deviation 1.27 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Tiredness: change from baseline @ W24 | 1.1 Percentage change in scores | Standard Deviation 2.52 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Tiredness change from BL @ EOT | 1.1 Percentage change in scores | Standard Deviation 2.28 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Filling up quickly when you eat (FUQWYE):BL | 0.8 Percentage change in scores | Standard Deviation 1.27 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | FUQWYE: change from BL @W12 | -0.1 Percentage change in scores | Standard Deviation 2.09 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | FUQWYE: change from BL @W24 | 0.1 Percentage change in scores | Standard Deviation 1.17 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | FUQWYE: change from BL @ EOT | 0.3 Percentage change in scores | Standard Deviation 2.29 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Abdominal discomfort (AD): BL | 0.6 Percentage change in scores | Standard Deviation 1.1 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Abdominal discomfort change from BL @W12 | -0.1 Percentage change in scores | Standard Deviation 0.85 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Abdominal discomfort change from BL @W24 | -0.3 Percentage change in scores | Standard Deviation 0.71 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | AD: change from BL @ EOT | 0.3 Percentage change in scores | Standard Deviation 1.4 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Night sweat (NS): Baseline (BL) | 1.1 Percentage change in scores | Standard Deviation 1.45 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | PUROLS: change from BL @W12 | 0.1 Percentage change in scores | Standard Deviation 0.76 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Night sweat change from BL @W24 | -0.7 Percentage change in scores | Standard Deviation 1.41 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Night Sweat: change from BL @ EOT | 0.3 Percentage change in scores | Standard Deviation 2.12 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Itching (Pruritus):BL | 0.6 Percentage change in scores | Standard Deviation 0.93 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Itching (Pruritus): change from BL @W12 | 0.1 Percentage change in scores | Standard Deviation 1.45 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Itching (Pruritus): change from BL @W24 | -0.3 Percentage change in scores | Standard Deviation 1.22 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Itching: change from BL @ EOT | 0.4 Percentage change in scores | Standard Deviation 1.75 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Bone Pain: BL | 0.9 Percentage change in scores | Standard Deviation 1.33 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Bone Pain: change from BL @W12 | 0.3 Percentage change in scores | Standard Deviation 1.56 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Bone Pain: change from BL @W24 | -0.8 Percentage change in scores | Standard Deviation 1.79 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Bone Pain: change from BL @ EOT | 0.6 Percentage change in scores | Standard Deviation 1.5 |
| Ruxolitinib Placebo | Percentage Change in Symptoms From Baseline Using MF-7 | Pain under ribs on left side (PUROLS): BL | 0.4 Percentage change in scores | Standard Deviation 0.82 |
Secondary
Plasma Ruxolitinib Concentrations
Characterize pharmacokinetics (PK)by utilizing a population PK approach.
Time frame: Week 12, Wk 48
Population: The Pharmacokinetics (PK) Analysis Set (PAS) consisted of all patients set who have received at least one dose of ruxolitinib and provided evaluable PK data. The PK analysis was never done as the study terminated early.
Secondary
Progression Free Survival (PFS-2)
PFS-2 assessed by 25% increase over new baseline of PFS-1 in any of the following: ● Progressive splenomegaly ● 25 % increase in MF-7 score with absolute score ≥ 30
Time frame: From date of randomization until second disease progression or death, whichever comes first (estimated to be assessed up to 72 months)
Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived
Secondary
Quality-adjusted Life Years From Baseline
EQ-5D-5L (EuroQol-5D-5L, is a standardized instrument for measuring health outcomes, is consists of a descriptive system and a visual analogue scale - scores can be summarized into a single index score that provides a simple measure of health for clinical and economic appraisal ) The EQ-5D-5L health states will be converted into index values (utilities) from which the QALY (Quality - adjusted life years) will be calculated. QALY will be summarized descriptively by treatment arm.
Time frame: Change from Baseline compared with scheduled study visits at the following intervals every 4 weeks up to week 24, every 8 weeks up to Week 48, every 12 weeks past Wk 48 until End of treatment and 30 day follow up visit
Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived.
Secondary
Time to First Progressive Splenomegaly (TTPS)
Time to first progressive splenomegaly as determined by spleen volume (by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT).
Time frame: From randomization until earliest time to progressive splenomegaly (estimated to be assessed up to 48 months)
Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived.
Secondary
Time to First Symptomatic Progression (TTSP)
Time to first symptomatic progression as determined by Myelofibrosis 7 Item Symptom Scale (MF-7)
Time frame: From randomization until symptomatic progression (MF-7)(estimated to be assessed up to 48 months)
Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived.
Secondary
Time to Primary Progression (TTP)
TTP is defined as time from randomization until disease progression as defined for PFS-1 excluding death as an event.
Time frame: From randomization till progression (estimated to be assessed up to 48 months)
Population: The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived.