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INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis. (JUMP)

Primary Purpose

Myelofibrosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

INC424

About this trial

This is an interventional treatment trial for Myelofibrosis focused on measuring Myelofibrosis, Primary myelofibrosis, PMF, Post polycythemia myelofibrosis, PPV MF, Post-essential thrombocythemia myelofibrosis, PET-MF, INC424, Ruxolitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

Patients must not be eligible for another ongoing INC424 clinical trial.
Patients must be diagnosed with PMF, PPV MF or PET-MF, according to the 2008 revised International Standard Criteria, irrespective of JAK2 mutation status..
Patients with PMF requiring therapy must be classified as high risk (3 prognostic factors) OR intermediate risk level 2 (2 prognostic factors, no more), OR intermediate risk level 1 (1 prognostic factor, no more) with an enlarged spleen (assessment to occur at the Screening Visit).
The prognostic factors, defined by the International Working Group are:
- Age > 65 years;
- Presence of constitutional symptoms (weight loss, fever, night sweats);
- Marked anemia (Hgb < 10g/dL)*;
- Leukocytosis (history of white blood cell (WBC) > 25 x109/L);
- Circulating blasts > 1%. * A hemoglobin value < 10 g/dL must be demonstrated during the Screening Visit for patients who are not transfusion dependent. Patients receiving regular transfusions of packed red blood cells will be considered to have hemoglobin < 10 g/dL for the purpose of evaluation of risk factors.
Patients with Intermediate-1 disease and splenomegaly must have a palpable spleen measuring 5 cm or greater from the costal margin to the point of greatest splenic protrusion.
Patients must have a peripheral blood blast count of < 10%.
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Fedratinib pretreated patients with documented complete physical examination including full neurologic examination and cardiology assessment, thiamine level testing, and MRI of the brain if indicated based on signs or symptoms. Patients pretreated with fedratinib should have completed or be receiving thiamine supplementation according to the investigator's instructions.

Main Exclusion Criteria:

Patients eligible for hematopoietic stem cell transplantation (suitable candidate and a suitable donor is available).
Patients with history of malignancy in past 3 years except for treated, early-stage squamous or basal cell carcinoma in situ.
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral INC424 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
Patients with cardiac disease which in the Investigator's opinion may jeopardize the safety of the patient or the compliance with the protocol.
Patients with currently uncontrolled or unstable angina, rapid or paroxysmal atrial fibrillation or recent (approximately 6 months) myocardial infarction or acute coronary syndrome.
Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
Patients with known active hepatitis A, B, C or who are HIV-positive.
Patients with inadequate bone marrow reserve at the Baseline visit as demonstrated by:
- Absolute neutrophil count (ANC) ≤ 1000/µL.
- Platelet count < 50,000/µL without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
Patients with any history of platelet counts < 50,000/µL or ANC < 500/µL except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason.
In the case of ruxolitinib pretreated patients, ruxolitinib primary resistant patients defined as:
• No spleen reduction within the first 12 weeks after front line therapy with ruxolitinib.
AND
• No reduction in symptoms within the first 12 weeks after first-line treatment with ruxolitinib.
In the case of ruxolitinib pretreated patients, patients discontinuing ruxolitinib due to a Grade 4 Adverse event (AE) related or suspected to be related to ruxolitinib.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INC424

Arm Description

5 - 25 mg twice a day (BID)

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years

An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A non-serious AE is any AE that does not meet the criteria above.

Secondary Outcome Measures

Percentage of Participants With at Least 50% Reduction in Spleen Length

Spleen length was assessed by manual palpation. Assessment of spleen response was repeated until early discontinuation of the study drug and also at study completion (28 days post end of treatment visit).

Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length

Overall response is analyzed using the spleen response, as assessed by the investigator and also by deriving the response using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. Participants with spleen length at baseline between 5 and 10 cm were reported as Responders if reporting non palpable spleen; Stable disease does not meet criteria for response or disease progression and Progressive disease with an increase of 100% from baseline in spleen length. Participants with spleen length at baseline more than 10 cm were reported as Responders with spleen reduction of 50% from baseline; Stable disease does not meet criteria for response or disease progression and Progressive disease with an increase of 50% from baseline in spleen length.

Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Worst Post-baseline ECOG Status up to 5 Years

ECOG Performance Score has 5 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. 5 = Death.

Change in Functional Assessment of Cancer Therapy (FACT-TOI, FACT-G) and FACT-Lymphoma (FACT-Lym) Total Scores Measured at Baseline and Week 48

The FACT-Lym questionnaire consists of a total of 42 questions divided between five subscales (i.e., physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma subscale). Each subscale questionnaire rates each question on a 5-point scale from 0 = Not at all to 4 = Very much. These scores were summed to three total sum scores, namely FACT-Lym score, FACT-Lym Trial Outcome Index (TOI), FACT-General (FACT-G) and FACT-Lym total score. Total scores: FACT-Lym=0-60, FACT-TOI=0-116, FACT-G total=0-108, FACT-Lym Total= 0-168. Higher scores are reflective of better HRQoL.

Time to First Improvement in FACT-Lym, FACIT-Fatigue Score and ECOG Performance Status

Improvement was defined by the upper limit of the minimally important difference (MID). Patients with the best possible score at Baseline were excluded from this analysis because their HRQoL cannot be further improved. Responders and non-responders for each endpoint were defined based on change from baseline scores using pre specified cut-off points. Patients with an improved score compared to Baseline, for which the magnitude of the change was at least the cutoff value, were classified as responders; otherwise, as non-responders. The responder cutoff: ECOG cutoff=1, range=0 to 5, FACT-Lym cutoff=5.4, range 0-60, FACIT-Fatigue =5 and range=0-52.The median time to first improvement was estimated using the Kaplan Meier method and time to improvement event was determined based on upper bound of the MID. The time to improvement was calculated from the date of first study drug administration.

Medical Resource Utilization up to 5 Years

Percentage of patients requiring medical resources (blood transfusions, hospitalization, emergency room visits, general practitioners or specialists consultations, urgent care or splenic irradiation) up to 5 years.

Full Information

NCT ID

NCT01493414

First Posted

December 13, 2011

Last Updated

April 25, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01493414

Brief Title

INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.

Acronym

JUMP

Official Title

An Open-label, Multicenter, Expanded Access Study of INC424 for Patients With Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-essential Thrombocythemia Myelofibrosis (PET-MF).

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 16, 2011 (undefined)

Primary Completion Date

January 26, 2017 (Actual)

Study Completion Date

January 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study was to collect additional safety of INC424 in patients with Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis, who either received prior treatment with commercially available agents or who have never received treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelofibrosis

Keywords

Myelofibrosis, Primary myelofibrosis, PMF, Post polycythemia myelofibrosis, PPV MF, Post-essential thrombocythemia myelofibrosis, PET-MF, INC424, Ruxolitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2233 (Actual)

8. Arms, Groups, and Interventions

Arm Title

INC424

Arm Type

Experimental

Arm Description

5 - 25 mg twice a day (BID)

Intervention Type

Drug

Intervention Name(s)

INC424

Other Intervention Name(s)

Ruxolitinib

Intervention Description

All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally.

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years

Description

Time Frame

Baseline up to approximately 5 years

Secondary Outcome Measure Information:

Title

Percentage of Participants With at Least 50% Reduction in Spleen Length

Description

Time Frame

Baseline up to approximately 5 years

Title

Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length

Description

Time Frame

Baseline up to approximately 5 years

Title

Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Worst Post-baseline ECOG Status up to 5 Years

Description

Time Frame

Baseline up to approximately 5 years

Title

Change in Functional Assessment of Cancer Therapy (FACT-TOI, FACT-G) and FACT-Lymphoma (FACT-Lym) Total Scores Measured at Baseline and Week 48

Description

Time Frame

Baseline and Week 48

Title

Time to First Improvement in FACT-Lym, FACIT-Fatigue Score and ECOG Performance Status

Description

Time Frame

Baseline up to approximately 5 years

Title

Medical Resource Utilization up to 5 Years

Description

Time Frame

Baseline up to approximately 5 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: Patients must not be eligible for another ongoing INC424 clinical trial. Patients must be diagnosed with PMF, PPV MF or PET-MF, according to the 2008 revised International Standard Criteria, irrespective of JAK2 mutation status.. Patients with PMF requiring therapy must be classified as high risk (3 prognostic factors) OR intermediate risk level 2 (2 prognostic factors, no more), OR intermediate risk level 1 (1 prognostic factor, no more) with an enlarged spleen (assessment to occur at the Screening Visit). The prognostic factors, defined by the International Working Group are: Age > 65 years; Presence of constitutional symptoms (weight loss, fever, night sweats); Marked anemia (Hgb < 10g/dL)*; Leukocytosis (history of white blood cell (WBC) > 25 x109/L); Circulating blasts > 1%. * A hemoglobin value < 10 g/dL must be demonstrated during the Screening Visit for patients who are not transfusion dependent. Patients receiving regular transfusions of packed red blood cells will be considered to have hemoglobin < 10 g/dL for the purpose of evaluation of risk factors. Patients with Intermediate-1 disease and splenomegaly must have a palpable spleen measuring 5 cm or greater from the costal margin to the point of greatest splenic protrusion. Patients must have a peripheral blood blast count of < 10%. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Fedratinib pretreated patients with documented complete physical examination including full neurologic examination and cardiology assessment, thiamine level testing, and MRI of the brain if indicated based on signs or symptoms. Patients pretreated with fedratinib should have completed or be receiving thiamine supplementation according to the investigator's instructions. Main Exclusion Criteria: Patients eligible for hematopoietic stem cell transplantation (suitable candidate and a suitable donor is available). Patients with history of malignancy in past 3 years except for treated, early-stage squamous or basal cell carcinoma in situ. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral INC424 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection). Patients with cardiac disease which in the Investigator's opinion may jeopardize the safety of the patient or the compliance with the protocol. Patients with currently uncontrolled or unstable angina, rapid or paroxysmal atrial fibrillation or recent (approximately 6 months) myocardial infarction or acute coronary syndrome. Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed. Patients with known active hepatitis A, B, C or who are HIV-positive. Patients with inadequate bone marrow reserve at the Baseline visit as demonstrated by: Absolute neutrophil count (ANC) ≤ 1000/µL. Platelet count < 50,000/µL without the assistance of growth factors, thrombopoietic factors or platelet transfusions. Patients with any history of platelet counts < 50,000/µL or ANC < 500/µL except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason. In the case of ruxolitinib pretreated patients, ruxolitinib primary resistant patients defined as: • No spleen reduction within the first 12 weeks after front line therapy with ruxolitinib. AND • No reduction in symptoms within the first 12 weeks after first-line treatment with ruxolitinib. In the case of ruxolitinib pretreated patients, patients discontinuing ruxolitinib due to a Grade 4 Adverse event (AE) related or suspected to be related to ruxolitinib.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Alger

Country

Algeria

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

1209

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1221ADC

Country

Argentina

Facility Name

Novartis Investigative Site

City

Paraná

State/Province

Entre Rios

ZIP/Postal Code

E3100BBJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1114AAN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

Novartis Investigative Site

City

Corrientes

ZIP/Postal Code

W3410AVV

Country

Argentina

Facility Name

Novartis Investigative Site

City

Innsbruck

State/Province

Tyrol

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

A-8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

A-4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1140

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A-1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Arlon

State/Province

Luxembourg

ZIP/Postal Code

1210

Country

Belgium

Facility Name

Novartis Investigative Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Novartis Investigative Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Novartis Investigative Site

City

Goiania

State/Province

ZIP/Postal Code

74605-050

Country

Brazil

Facility Name

Novartis Investigative Site

City

Belo Horizonte

State/Province

ZIP/Postal Code

30130-100

Country

Brazil

Facility Name

Novartis Investigative Site

City

Curitiba

State/Province

ZIP/Postal Code

80060-900

Country

Brazil

Facility Name

Novartis Investigative Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20.211-030

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Novartis Investigative Site

City

Campinas

State/Province

ZIP/Postal Code

13083-970

Country

Brazil

Facility Name

Novartis Investigative Site

City

Ribeirao Preto

State/Province

ZIP/Postal Code

14048-900

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

01224-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

05651-901

Country

Brazil

Facility Name

Novartis Investigative Site

City

São Paulo

State/Province

ZIP/Postal Code

08270-070

Country

Brazil

Facility Name

Novartis Investigative Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z1Y6

Country

Canada

Facility Name

Novartis Investigative Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 6Z8

Country

Canada

Facility Name

Novartis Investigative Site

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V6

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 1V7

Country

Canada

Facility Name

Novartis Investigative Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Novartis Investigative Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 2X3

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1S6

Country

Canada

Facility Name

Novartis Investigative Site

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Novartis Investigative Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

Novartis Investigative Site

City

Bogota

State/Province

Cundinamarca

ZIP/Postal Code

111411

Country

Colombia

Facility Name

Novartis Investigative Site

City

Medellín

Country

Colombia

Facility Name

Novartis Investigative Site

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

639 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Hradec Kralove

State/Province

Czech Republic

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 2

State/Province

Czech Republic

ZIP/Postal Code

128 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Mannheim

State/Province

Baden-Württemberg

ZIP/Postal Code

68305

Country

Germany

Facility Name

Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14195

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53113

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53119

Country

Germany

Facility Name

Novartis Investigative Site

City

Bottrop

ZIP/Postal Code

46236

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

ZIP/Postal Code

28177

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

ZIP/Postal Code

09113

Country

Germany

Facility Name

Novartis Investigative Site

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44263

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Duisburg

ZIP/Postal Code

47166

Country

Germany

Facility Name

Novartis Investigative Site

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt, Oder

ZIP/Postal Code

15236

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Friedrichshafen

ZIP/Postal Code

88045

Country

Germany

Facility Name

Novartis Investigative Site

City

Goslar

ZIP/Postal Code

38642

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Novartis Investigative Site

City

Göttingen

ZIP/Postal Code

D-37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Halle

ZIP/Postal Code

06110

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamm

ZIP/Postal Code

59063

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Hildesheim

ZIP/Postal Code

31135

Country

Germany

Facility Name

Novartis Investigative Site

City

Ingolstadt

ZIP/Postal Code

85049

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

D-24116

Country

Germany

Facility Name

Novartis Investigative Site

City

Koeln

ZIP/Postal Code

50671

Country

Germany

Facility Name

Novartis Investigative Site

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Leer

ZIP/Postal Code

26789

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novartis Investigative Site

City

Minden

ZIP/Postal Code

32429

Country

Germany

Facility Name

Novartis Investigative Site

City

Moers

ZIP/Postal Code

47441

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80331

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81241

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

ZIP/Postal Code

90403

Country

Germany

Facility Name

Novartis Investigative Site

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70376

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

GR-106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

GR 11527

Country

Greece

Facility Name

Novartis Investigative Site

City

Patras

ZIP/Postal Code

265 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

H-1097

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

H-4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kaposvár

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

H-6720

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Novartis Investigative Site

City

Cork City

State/Province

Cork

Country

Ireland

Facility Name

Novartis Investigative Site

City

Afula

ZIP/Postal Code

1834111

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3339419

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

5266202

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel-Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Alessandria

State/Province

ZIP/Postal Code

15100

Country

Italy

Facility Name

Novartis Investigative Site

City

Ancona

State/Province

ZIP/Postal Code

60126

Country

Italy

Facility Name

Novartis Investigative Site

City

Avellino

State/Province

ZIP/Postal Code

83100

Country

Italy

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70124

Country

Italy

Facility Name

Novartis Investigative Site

City

Bergamo

State/Province

ZIP/Postal Code

24128

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Cagliari

State/Province

ZIP/Postal Code

09100

Country

Italy

Facility Name

Novartis Investigative Site

City

Cagliari

State/Province

ZIP/Postal Code

09126

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95100

Country

Italy

Facility Name

Novartis Investigative Site

City

Catania

State/Province

ZIP/Postal Code

95124

Country

Italy

Facility Name

Novartis Investigative Site

City

Catanzaro

State/Province

ZIP/Postal Code

88100

Country

Italy

Facility Name

Novartis Investigative Site

City

Cona

State/Province

ZIP/Postal Code

44100

Country

Italy

Facility Name

Novartis Investigative Site

City

San Giovanni Rotondo

State/Province

ZIP/Postal Code

71013

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Lecce

State/Province

ZIP/Postal Code

73100

Country

Italy

Facility Name

Novartis Investigative Site

City

Monza

State/Province

ZIP/Postal Code

20900

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20133

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Novartis Investigative Site

City

Modena

State/Province

ZIP/Postal Code

41100

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90146

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Pescara

State/Province

ZIP/Postal Code

65124

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56126

Country

Italy

Facility Name

Novartis Investigative Site

City

Pesaro

State/Province

ZIP/Postal Code

61100

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Rionero in Vulture

State/Province

ZIP/Postal Code

85028

Country

Italy

Facility Name

Novartis Investigative Site

City

Ravenna

State/Province

ZIP/Postal Code

48100

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Calabria

State/Province

ZIP/Postal Code

89124

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Emilia

State/Province

ZIP/Postal Code

42123

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00128

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00133

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00144

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00152

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00185

Country

Italy

Facility Name

Novartis Investigative Site

City

Pagani

State/Province

ZIP/Postal Code

84016

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Taranto

State/Province

ZIP/Postal Code

74100

Country

Italy

Facility Name

Novartis Investigative Site

City

Orbassano

State/Province

ZIP/Postal Code

10043

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Terni

State/Province

ZIP/Postal Code

05100

Country

Italy

Facility Name

Novartis Investigative Site

City

Treviso

State/Province

ZIP/Postal Code

31100

Country

Italy

Facility Name

Novartis Investigative Site

City

Udine

State/Province

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novartis Investigative Site

City

Varese

State/Province

ZIP/Postal Code

21100

Country

Italy

Facility Name

Novartis Investigative Site

City

Venezia

State/Province

ZIP/Postal Code

30174

Country

Italy

Facility Name

Novartis Investigative Site

City

Vicenza

State/Province

ZIP/Postal Code

36100

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37126

Country

Italy

Facility Name

Novartis Investigative Site

City

Ronciglione

State/Province

ZIP/Postal Code

01100

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80132

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80136

Country

Italy

Facility Name

Novartis Investigative Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

ZIP/Postal Code

06129

Country

Italy

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

06726

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

Novartis Investigative Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64020

Country

Mexico

Facility Name

Novartis Investigative Site

City

Hermosillo

State/Province

Sonora

ZIP/Postal Code

83000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Puebla

ZIP/Postal Code

72000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Marrakech

Country

Morocco

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-958

Country

Poland

Facility Name

Novartis Investigative Site

City

Katowice

ZIP/Postal Code

40-027

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

31-503

Country

Poland

Facility Name

Novartis Investigative Site

City

Opole

ZIP/Postal Code

45-372

Country

Poland

Facility Name

Novartis Investigative Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Novartis Investigative Site

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Novartis Investigative Site

City

Faro

ZIP/Postal Code

8000-386

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1749-035

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Novartis Investigative Site

City

Vila Real

ZIP/Postal Code

5000 - 508

Country

Portugal

Facility Name

Novartis Investigative Site

City

Irkutsk

ZIP/Postal Code

664079

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125167

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhnii Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630051

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Rostov-on-Don

ZIP/Postal Code

344022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

191024

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Jeddah

ZIP/Postal Code

21423

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Riyadh

ZIP/Postal Code

11426

Country

Saudi Arabia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

85107

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Soweto

State/Province

Gauteng

ZIP/Postal Code

2013

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

State/Province

Western Province

ZIP/Postal Code

7801

Country

South Africa

Facility Name

Novartis Investigative Site

City

Johannesburg

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Novartis Investigative Site

City

Pretoria

ZIP/Postal Code

0027

Country

South Africa

Facility Name

Novartis Investigative Site

City

Ferrol

State/Province

A Coruna

ZIP/Postal Code

15405

Country

Spain

Facility Name

Novartis Investigative Site

City

Granada

State/Province

Andalucia

ZIP/Postal Code

18014

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Cadiz

State/Province

Andalucía

ZIP/Postal Code

11009

Country

Spain

Facility Name

Novartis Investigative Site

City

Jaen

State/Province

Andalucía

ZIP/Postal Code

23007

Country

Spain

Facility Name

Novartis Investigative Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33006

Country

Spain

Facility Name

Novartis Investigative Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novartis Investigative Site

City

Toledo

State/Province

Castilla La Mancha

ZIP/Postal Code

45071

Country

Spain

Facility Name

Novartis Investigative Site

City

Burgos

State/Province

Castilla Y Leon

ZIP/Postal Code

09005

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

State/Province

Castilla Y Leon

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Valladolid

State/Province

Castilla Y Leon

ZIP/Postal Code

47012

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Girona

State/Province

Catalunya

ZIP/Postal Code

17007

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de LLobregat

State/Province

Catalunya

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Tarragona

State/Province

Catalunya

ZIP/Postal Code

43005

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03010

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Palma De Mallorca

State/Province

Islas Baleares

ZIP/Postal Code

07120

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas de Gran Canaria

State/Province

Las Palmas De G.C

ZIP/Postal Code

35010

Country

Spain

Facility Name

Novartis Investigative Site

City

Alcala de Henares

State/Province

Madrid

ZIP/Postal Code

28805

Country

Spain

Facility Name

Novartis Investigative Site

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novartis Investigative Site

City

Pozuelo de Alarcón

State/Province

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian de los Reyes

State/Province

Madrid

ZIP/Postal Code

28702

Country

Spain

Facility Name

Novartis Investigative Site

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

Bilbao

State/Province

Pais Vasco

ZIP/Postal Code

48013

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian

State/Province

Pais Vasco

ZIP/Postal Code

20080

Country

Spain

Facility Name

Novartis Investigative Site

City

Logrono

State/Province

Rioja

ZIP/Postal Code

26006

Country

Spain

Facility Name

Novartis Investigative Site

City

La Laguna

State/Province

Santa Cruz De Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Novartis Investigative Site

City

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas de Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50015

Country

Spain

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novartis Investigative Site

City

Sfax

State/Province

Tunisie

ZIP/Postal Code

3029

Country

Tunisia

Facility Name

Novartis Investigative Site

City

Sousse

ZIP/Postal Code

4000

Country

Tunisia

Facility Name

Novartis Investigative Site

City

Tunis

ZIP/Postal Code

1008

Country

Tunisia

Facility Name

Novartis Investigative Site

City

Tunis

Country

Tunisia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33210570

Citation

Gupta V, Griesshammer M, Martino B, Foltz L, Tavares R, Al-Ali HK, Giraldo P, Guglielmelli P, Lomaia E, Bouard C, Paley C, Tiwari R, Zor E, Raanani P. Analysis of predictors of response to ruxolitinib in patients with myelofibrosis in the phase 3b expanded-access JUMP study. Leuk Lymphoma. 2021 Apr;62(4):918-926. doi: 10.1080/10428194.2020.1845334. Epub 2020 Nov 19.

Results Reference

derived

PubMed Identifier

32017044

Citation

Al-Ali HK, Griesshammer M, Foltz L, Palumbo GA, Martino B, Palandri F, Liberati AM, le Coutre P, Garcia-Hernandez C, Zaritskey A, Tavares R, Gupta V, Raanani P, Giraldo P, Hanel M, Damiani D, Sacha T, Bouard C, Paley C, Tiwari R, Mannelli F, Vannucchi AM. Primary analysis of JUMP, a phase 3b, expanded-access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts. Br J Haematol. 2020 Jun;189(5):888-903. doi: 10.1111/bjh.16462. Epub 2020 Feb 4.

Results Reference

derived

PubMed Identifier

31235325

Citation

Tavares R, Souza CA, Paley C, Bouard C, Tiwari R, Pasquini R. A subgroup analysis of JUMP, a phase IIIb, expanded-access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis in a Brazilian cohort. Hematol Transfus Cell Ther. 2020 Jan-Mar;42(1):46-53. doi: 10.1016/j.htct.2019.01.009. Epub 2019 Apr 25.

Results Reference

derived

PubMed Identifier

27247324

Citation

Al-Ali HK, Griesshammer M, le Coutre P, Waller CF, Liberati AM, Schafhausen P, Tavares R, Giraldo P, Foltz L, Raanani P, Gupta V, Tannir B, Ronco JP, Ghosh J, Martino B, Vannucchi AM. Safety and efficacy of ruxolitinib in an open-label, multicenter, single-arm phase 3b expanded-access study in patients with myelofibrosis: a snapshot of 1144 patients in the JUMP trial. Haematologica. 2016 Sep;101(9):1065-73. doi: 10.3324/haematol.2016.143677. Epub 2016 May 31.

Results Reference

derived

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INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis.

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INC424 for Patients With Primary Myelofibrosis, Post Polycythemia Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis. (JUMP)

Myelofibrosis

About this trial

Eligibility Criteria

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Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

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1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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