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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02038036
Registration number
NCT02038036
Ethics application status
Date submitted
14/01/2014
Date registered
16/01/2014
Date last updated
20/07/2021
Titles & IDs
Public title
Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy.
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Scientific title
Randomized, Open Label, Multicenter Phase IIIb Study Evaluating the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant (Response 2)
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Secondary ID [1]
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0
CINC424B2401
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Universal Trial Number (UTN)
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Trial acronym
RESPONSE-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polycythemia Vera
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Condition category
Condition code
Blood
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Haematological diseases
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Blood
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0
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Best Available Therapy
Treatment: Drugs - Ruxolitinib
Experimental: Ruxolitinib - Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.
Active Comparator: Best Available Therapy (BAT) - Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.
Treatment: Drugs: Best Available Therapy
Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.
Treatment: Drugs: Ruxolitinib
Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Achieving Hematocrit (Hct) Control at Week 28
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Assessment method [1]
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Proportion of patients achieving Hct control at Week 28 was defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8.
Phlebotomy eligibility was defined by:
Confirmed Hct > 45% that is at least 3 percentage points higher than the Hct obtained at Baseline Or
Confirmed Hct > 48% The confirmation occurred 2 to 14 days subsequent to the initial observation.
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Timepoint [1]
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Week 28
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Secondary outcome [1]
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Number of Participants Achieving a Complete Hematological Remission at Week 28
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Assessment method [1]
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Proportion of patients achieving a complete hematological remission at Week 28 was defined by:
Hct control at Week 28 defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and
WBC < 10 x109/L at Week 28, and
Platelets = 400 x 109/L at Week 28
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Timepoint [1]
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Week 28
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Secondary outcome [2]
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Number of Participants Achieving a Hematocrit (Hct) Control at Week 52 and Week 80
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Assessment method [2]
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Proportion of patients achieving a Hct control at Week 52 was defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52, and no more than one phlebotomy eligibility occurring post randomization and prior to Week 8
- Endpoint for Week 80 was defined, similarly.
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Timepoint [2]
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Week 52 and 80
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Secondary outcome [3]
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Number of Participants Achieving a Complete Hematological Remission at Week 52 and Week 80
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Assessment method [3]
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Proportion of patients achieving a complete hematological remission at Week 52, was defined by:
Hct control at Week 52, as defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52 with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and
White Blood Count (WBC) < 10 x10^9/L at Week 52, and
Platelets = 400 x 10^9/L at Week 52
Endpoint for Week 80 was defined, similarly.
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Timepoint [3]
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Week 52 and 80
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Secondary outcome [4]
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Number of Participants With Phlebotomies Over Time
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Assessment method [4]
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Phlebotomy eligibility was defined by Confirmed Hct > 45% that is at least 3 percentage points higher than the Hct obtained at Baseline Or Confirmed Hct > 48%. The confirmation occurred 2 to 14 days subsequent to the initial observation.
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Timepoint [4]
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Baseline to Week 260
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Secondary outcome [5]
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Change From Baseline in Hematocrit (Hct) at Each Visit
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Assessment method [5]
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Hematocrit is the volume percentage of red blood cells (RBC) in the blood.
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Timepoint [5]
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Baseline, Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 66, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247 and 260
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Secondary outcome [6]
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Change From Baseline in Hematocrit (Hct) at Each Scheduled Visit After Crossover in Participants Randomized to BAT Who Cross Over to Ruxolitinib
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Assessment method [6]
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Hematocrit is the percentage of red blood cells (RBC) in the blood.
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Timepoint [6]
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Baseline (last assessment before cross over), Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 64, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206, 219 and 232 after cross-over
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Secondary outcome [7]
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Spleen Length by Visit
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Assessment method [7]
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Spleen length was assessed by manual palpation at every study visit.
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Timepoint [7]
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Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 66, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234, 247 and 260
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Secondary outcome [8]
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Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Week 28
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Assessment method [8]
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The ECOG scale of performance status described the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. The ECOG performance was recorded as per ECOG performance status grades ranging from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead).
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Timepoint [8]
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Baseline and Week 28
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Secondary outcome [9]
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Number of Participants Achieving a Partial Remission Based on the European Leukemia Net (ELN) and International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) Criteria at Week 28
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Assessment method [9]
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Proportion of patients achieving a partial remission at Week 28, based on the ELN and IWG-MRT criteria, as defined by:
Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) score reduction of greater than or equal to 10 points from baseline to Week 28, and
Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and
WBC < 10 x10^9/L at Week 28, and
Platelets = 400 x 10^9/L at Week 28, and
No palpable spleen at Week 28, and
No hemorrhagic or thrombotic events, and
No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria).
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Timepoint [9]
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Week 28
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Secondary outcome [10]
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Number of Participants Who Achieved Partial Remission Based on the European Leukemia Net (ELN) and International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) Criteria at Week 52 and Week 80
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Assessment method [10]
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Proportion of patients who achieved partial remission at Week 52 based on the ELN and IWG-MRT criteria, as defined by:
MPN-SAF TSS score reduction of greater than or equal to 10 points from baseline to Week 52 and
Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52 with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and
WBC < 10 x109/L at Week 52 and
Platelets = 400 x 109/L at Week 52 and
No palpable spleen at Week 52 and
No hemorrhagic or thrombotic events, and
No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria).
Endpoint for Week 80 was defined, similarly.
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Timepoint [10]
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Week 52 and 80
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Secondary outcome [11]
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Number of Participants Achieving a Hematocrit (Hct) Control at Week 104, Week 156, Week 208 and Week 260.
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Assessment method [11]
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Proportion of patients achieving a Hct control at Week 104 as defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104 and with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8 Endpoint for Week 156, Week 208 and Week 260 were defined, similarly.
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Timepoint [11]
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From Week 8 to Week 104, 156, 208 and 260
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Secondary outcome [12]
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Number of Participants Achieving a Complete Hematological Remission at Week 104, Week 156, Week 208 and Week 260
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Assessment method [12]
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Proportion of patients achieving a complete hematological remission at Week 104 as defined by Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and
WBC < 10 x10^9/L at Week 104, and
Platelets = 400 x 10^9/L at Week 104 Endpoint for Week 156, Week 208 and Week 260 were defined, similarly.
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Timepoint [12]
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From Week 8 to Week 104, 156, 208 and 260
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Secondary outcome [13]
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Number of Participants Who Achieved Partial Remission Based on the European Leukemia Net (ELN) and International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) Criteria at Week 104, Week 156, Week 208 and Week 260.
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Assessment method [13]
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Proportion of patients who achieved partial remission at Week 104, based on the ELN and IWG-MRT criteria, as defined by:
MPN-SAF TSS score reduction of greater than or equal to 10 points from baseline to Week 104, and
Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104, with no more than one phlebotomy eligibility occurring post-randomization and prior to Week 8, and
WBC < 10 x10^9/L at Week 104, and
Platelets = 400 x 10^9/L at Week 104, and
No palpable spleen at Week 104, and
No hemorrhagic or thrombotic events, and
No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria) Endpoint for Week 156, Week 208 and Week 260 are defined, similarly.
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Timepoint [13]
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From Week 8 to Week 104, 156, 208 and 260
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Secondary outcome [14]
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Number of Participants With Transformation Free Survival Events
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Assessment method [14]
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Transformation-free survival is defined as one of the following:
Myelofibrosis (MF) as evidenced by bone marrow biopsy, or
Acute leukemia as evidenced by bone marrow blast counts of at least 20%, or peripheral blast counts of at least 20% lasting at least 2 weeks.
Death due to any cause during treatment period
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Timepoint [14]
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Week 260 (ruxolitinib arm) and Week 80 (BAT arm)
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Secondary outcome [15]
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Number of Participants With Overall Survival (OS) Events
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Assessment method [15]
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Overall survival (OS) event is defined as death due to any cause. OS events were counted in the BAT arm, irrespective of whether participants crossed over to receive ruxolitinib when the event occurred.
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Timepoint [15]
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up to Week 260
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Secondary outcome [16]
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Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
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Assessment method [16]
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The MPN-SAF TSS is a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms. Each item is scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable).The MPN-SAF TSS is computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus has a possible score range of 0 to 100 where a decrease indicates improvement.
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Timepoint [16]
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Baseline, Week 4, 8, 16, 28, 40, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247
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Secondary outcome [17]
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Change From Baseline in Total Scores of MPN-SAF by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover
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Assessment method [17]
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The MPN-SAF TSS is a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms. Each item is scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable).The MPN-SAF TSS is computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale. The MPN-SAF TSS thus has a possible score range of 0 to 100 where a decrease indicates improvement.
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Timepoint [17]
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Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 40, 52, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 after cross-over
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Secondary outcome [18]
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Change From Baseline in Score as Per European Quality of Life 5-Dimension 5-level (EQ-5D-5L) Questionnaire
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Assessment method [18]
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EQ-5D-5L is a standardized instrument for measuring health outcomes in a wide range of health conditions and treatments. It consists of visual analogue scale (EQ VAS) which records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'worst imaginable health state'. The EQ VAS scores were anchored on 100 = the best health you can imagine and 0 = worst health you can imagine.
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Timepoint [18]
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Baseline, Week 4, 8, 16, 28, 52, 80, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247
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Secondary outcome [19]
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Change From Baseline in EQ-5D-5L VAS, by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover
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Assessment method [19]
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EQ-5D-5L is a standardized instrument for measuring health outcomes in a wide range of health conditions and treatments. It consists of visual analogue scale (EQ VAS) which records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labeled 'Best imaginable health state' and 'worst imaginable health state'. The EQ VAS scores were anchored on 100 = the best health you can imagine and 0 = worst health you can imagine.
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Timepoint [19]
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Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 52, 92, 104, 117, 130, 143, 156, 169, 182, 195, 208, 221, 234 and 247 after cross-over
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Secondary outcome [20]
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Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire
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Assessment method [20]
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The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) is a six item questionnaire which intended to measure work and activity impairment associated with polycythemia vera. WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the polycythemia vera; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the polycythemia vera on productivity while working; Q6=Impact of the polycythemia vera on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. Scores were multiplied by 100 to express in percentages.
Percent work time missed due to problem (past 7 days) =Q2/(Q2+Q4) Percent impairment while working due to problem (past 7 days): Q5/10 Percent overall work impairment due to problem (past 7 says): Q2/(Q2+Q4)+[(1 Q2/(Q2+Q4))x(Q5/10)] Percent activity impairment due to problem (past 7 says): Q6/10
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Timepoint [20]
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Baseline, Week 4, 8, 16, 28, 52 and 80
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Secondary outcome [21]
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Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI), by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover
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Assessment method [21]
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The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) is a six item questionnaire which intended to measure work and activity impairment associated with polycythemia vera. WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the polycythemia vera; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the polycythemia vera on productivity while working; Q6=Impact of the polycythemia vera on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. Scores were multiplied by 100 to express in percentages.
Percent work time missed due to problem (past 7 days) =Q2/(Q2+Q4) Percent impairment while working due to problem (past 7 days): Q5/10 Percent overall work impairment due to problem (past 7 says): Q2/(Q2+Q4)+[(1 Q2/(Q2+Q4))x(Q5/10)] Percent activity impairment due to problem (past 7 says): Q6/10
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Timepoint [21]
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Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28 and 52 after cross-over
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Secondary outcome [22]
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Patient Global Impression of Change (PGIC)
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Assessment method [22]
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The Patient Global Impression of Change (PGIC) is comprised of a single question intended to measure a patient's perspective of improvement or deterioration over time relative to treatment. The PGIC uses a seven-point scale where one (1) equals very much improved and seven (7) equals very much worse.
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Timepoint [22]
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Week 4, 8, 16, 28, 40, 52 and 80
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Secondary outcome [23]
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Summary of Patient Global Impression of Change (PGIC), by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover
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Assessment method [23]
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The Patient Global Impression of Change (PGIC) is comprised of a single question intended to measure a patient's perspective of improvement or deterioration over time relative to treatment. The PGIC uses a seven-point scale where one (1) equals very much improved and seven (7) equals very much worse.
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Timepoint [23]
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Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 40, and 52 after cross-over
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Secondary outcome [24]
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Number of Participants Developing Thrombosis
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Assessment method [24]
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Proportion of participants developing any arterial or venous thromboembolic event
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Timepoint [24]
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From randomization to Week 80 for BAT and Week 260 for Ruxolitinib
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Eligibility
Key inclusion criteria
Confirmed diagnosis of PV according to the 2008 World Health Organization criteria,
Non-palpable spleen, Phlebotomy dependent, Resistant to or intolerant of hydroxyurea, ECOG
performance status of 0, 1 or 2.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral
infection requiring treatment, Active malignancy within the past 5 years, excluding
specific skin cancers, Previously received treatment with a JAK inhibitor, Being treated
with any investigational agent, Women who are pregnant or nursing.
Other inclusion/exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/04/2020
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Sample size
Target
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Accrual to date
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Final
149
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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0
Novartis Investigative Site - Herston
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Recruitment postcode(s) [1]
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0
4029 - Herston
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Recruitment outside Australia
Country [1]
0
0
Belgium
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State/province [1]
0
0
Antwerpen
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Country [2]
0
0
Belgium
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State/province [2]
0
0
Leuven
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Country [3]
0
0
Canada
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State/province [3]
0
0
Ontario
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Country [4]
0
0
France
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State/province [4]
0
0
Bayonne Cedex
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Country [5]
0
0
France
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State/province [5]
0
0
Bordeaux
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Country [6]
0
0
France
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State/province [6]
0
0
Brest
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Country [7]
0
0
France
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State/province [7]
0
0
Lille cedex
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Country [8]
0
0
France
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State/province [8]
0
0
Nice Cedex
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Country [9]
0
0
France
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State/province [9]
0
0
Paris
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Country [10]
0
0
France
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State/province [10]
0
0
Toulouse
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Country [11]
0
0
Germany
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State/province [11]
0
0
Baden-Wuerttemberg
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Country [12]
0
0
Germany
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State/province [12]
0
0
Augsburg
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Country [13]
0
0
Germany
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State/province [13]
0
0
Dresden
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Country [14]
0
0
Germany
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State/province [14]
0
0
Jena
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Country [15]
0
0
Germany
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State/province [15]
0
0
Leipzig
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Country [16]
0
0
Germany
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State/province [16]
0
0
Magdeburg
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Country [17]
0
0
Germany
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State/province [17]
0
0
Mainz
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Country [18]
0
0
Germany
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State/province [18]
0
0
Minden
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Country [19]
0
0
Germany
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State/province [19]
0
0
Ulm
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Country [20]
0
0
Hungary
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State/province [20]
0
0
Budapest
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Country [21]
0
0
Hungary
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State/province [21]
0
0
Debrecen
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Country [22]
0
0
Hungary
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State/province [22]
0
0
Kaposvar
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Country [23]
0
0
India
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State/province [23]
0
0
Maharashtra
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Country [24]
0
0
India
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State/province [24]
0
0
Tamil Nadu
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Country [25]
0
0
Israel
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State/province [25]
0
0
Nahariya
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Country [26]
0
0
Israel
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State/province [26]
0
0
Netanya
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Country [27]
0
0
Israel
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State/province [27]
0
0
Tel Aviv
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Country [28]
0
0
Italy
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State/province [28]
0
0
BO
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Country [29]
0
0
Italy
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State/province [29]
0
0
FI
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Country [30]
0
0
Italy
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State/province [30]
0
0
Lazio
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Country [31]
0
0
Italy
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State/province [31]
0
0
MI
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Country [32]
0
0
Italy
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State/province [32]
0
0
PV
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Country [33]
0
0
Italy
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State/province [33]
0
0
TO
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Country [34]
0
0
Italy
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State/province [34]
0
0
VA
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Country [35]
0
0
Korea, Republic of
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State/province [35]
0
0
Seoul
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Country [36]
0
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Spain
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Andalucia
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Spain
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Castilla Y Leon
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Spain
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Catalunya
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Country [39]
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Spain
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State/province [39]
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Comunidad Valenciana
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Country [40]
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Spain
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State/province [40]
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Galicia
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Country [41]
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Spain
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State/province [41]
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Las Palmas De G.C
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Spain
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State/province [42]
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Navarra
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Country [43]
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Spain
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Madrid
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Country [44]
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Turkey
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State/province [44]
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Izmir
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Turkey
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Talas / Kayseri
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in
patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and
did not have a palpable spleen.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02038036
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02038036
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