Primary MyelofibrosisJAKoMoNCT05044026
A Prospective, Two-arm, Non-interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis
An observational study of Primary Myelofibrosis and Post-polycythemia Vera Myelofibrosis, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
This was a prospective, two-arm, non-interventional study of JAKAVI® (Ruxolitinib) in patients with myelofibrosis Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- What is being tested?
- Jakavi
- How many people
- 1,012 participants
- Where
- 1 siteGermany
- Study dates
- 20 Sep 2012to 19 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia Myelofibrosis (PET-MF), for whom Jakavi® therapy is indicated.
Who may be able to join
- Male and female patients with Primary Myelofibrosis (PMF), post-Polycythemia Vera-Myelofibrosis (PPV-MF), or post-Essential Thrombocythemia-Myelofibrosis (post-ET-MF), for whom Jakavi® therapy is indicated.
- Patients that were informed about all aspects of this NIS and provided written informed consent.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Two-arm, Non Interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis
This was a prospective, two-arm, non-interventional study of JAKAVI® (Ruxolitinib) in patients with myelofibrosis
Read the detailed description
The purpose of this NIS was to gather data from the daily clinical practice of the Jakavi®-treatment in a broad patient population. In order to evaluate the direct effect of Jakavi®, only JAK inhibitor naive patients were documented in the first study arm; patients pretreated with JAK inhibitors were documented in the second study arm to evaluate the long-term efficacy of Jakavi® in this subpopulation.
The documentation of all patients was carried out prospectively and began after the baseline visit. The medical decision on which therapeutic and diagnostic measures to take was made solely by the responsible physician. The observational period per patient was 36 months. The visit schedule after the baseline visit was set by the responsible physician according to standard clinical care, the clinical condition of the respective patients and the SmPC.
- Conditions
- Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Being tested
- Jakavi
- Keywords
- Primary Myelofibrosis, PMF, post-polycythemia vera myelofibrosis, PPV MF, post-essential thrombocythemia myelofibrosis, post ET MF, Ruxolitinib, Jakavi
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JakaviOther
Also called Ruxolitinib
Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: JAK inhibitor naive | JAK-inhibitor-naive patients, treatment start with ruxolitinib less than 14 days prior to the baseline visit Receives: Other: Jakavi | |
| Arm B: Pretreated patients | Patients pretreated with a JAK-inhibitor for more than 14 days prior to the baseline visit Receives: Other: Jakavi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Evaluation of all occurring adverse events, serious adverse events and serious and non-serious adverse drug reactions
Measured: Up to 36 months
Spleen size (or volume) reduction
Spleen size (or volume) reduction was measured by palpation
Measured: Up to 36 months
Eastern Cooperative Oncology Group (ECOG) performance status
The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
The grade ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead).
Measured: Up to 36 months
Change in the number of patients with constitutional symptoms
Number of patients with change in constitutional symptoms was collected
Measured: Up to 36 months
Assessment of the Quality of Life (QoL) - Myeloproliferative Neoplasm - Symptom Assessment Form (MPN-SAF)
The MPN-SAF questionnaire contains important questions that cover MF-specific symptoms whose analysis is part of the standard of care. It includes disease related symptoms each scored from 0 (absent) to 10 (worst imaginable). Total Scores range from 0-100, with higher scores indicating a greater number of symptoms and severity.
Measured: Baseline, month 1, month 3, month 6, month 12, month 24 and month 36
Assessment of the Quality of Life (QoL) - Short Form-36 (SF-36)
This questionnaire consists of questions measuring physical function, physical role limitation, pain, general health, vitality, social function, emotional role limitations, and mental health status. The scores that can be obtained from the scale vary between 0 and 100 and the increase in the scores indicates that the quality of life is high.
Measured: Baseline month 6, month 12, month 24 and month 36
Overall survival
Overall survival for JAK inhibitor naive and pretreated patients
Measured: Up to 36 months
Ruxolitinib start and end dose
Ruxolitinib start and end dose was collected
Measured: Up to 36 months
Therapy discontinuation and dose adjustments
Number of participants with therapy discontinuation and dose adjustments was collected
Measured: Up to 36 months
Number of patients with co-morbidities
Number of patients with co-morbidities was collected
Measured: Up to 36 months
Blood transfusion dependency
Number of patients with blood transfusion dependency was collected
Measured: Up to 36 months
Number of patients with concomitant medications
Number of patients with concomitant medications prescribed for myelofibrosis therapy and for the management of side effects was collected
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start20 Sep 2012
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044026
- Sponsor's protocol ID
- CINC424ADE05
- Acronym
- JAKoMo
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Koschmieder S, Isfort S, Schulte C, Jacobasch L, Geer T, Reiser M, Koenigsmann M, Heinrich B, Wehmeyer J, von der Heyde E, Tesch H, Groschl B, Bachhuber P, Grosser S, Koehler M, Pahl HL. Final Results From a Large, Non-Interventional, Phase 4 Study of Ruxolitinib for the Treatment of Myelofibrosis in Clinical Routine. Eur J Haematol. 2025 Oct;115(4):380-390. doi: 10.1111/ejh.70005. Epub 2025 Jul 6.
PubMed 40619737Koschmieder S, Isfort S, Schulte C, Jacobasch L, Geer T, Reiser M, Koenigsmann M, Heinrich B, Wehmeyer J, von der Heyde E, Tesch H, Groschl B, Bachhuber P, Grosser S, Pahl HL. Real-world analysis of ruxolitinib in myelofibrosis: interim results focusing on patients who were naive to JAK inhibitor therapy treated within the JAKoMo non-interventional, phase IV trial. Ann Hematol. 2023 Dec;102(12):3383-3399. doi: 10.1007/s00277-023-05458-1. Epub 2023 Oct 4.
PubMed 37792065
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Two-arm, Non Interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis
- ClinicalTrials.gov ID
- NCT05044026
- Acronym / sponsor ID
- JAKoMo / CINC424ADE05
- Conditions
- Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Keywords
- Primary Myelofibrosis, PMF, post-polycythemia vera myelofibrosis, PPV MF, post-essential thrombocythemia myelofibrosis, post ET MF, Ruxolitinib, Jakavi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2012 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a prospective, two-arm, non-interventional study of JAKAVI® (Ruxolitinib) in patients with myelofibrosis
Detailed description
The purpose of this NIS was to gather data from the daily clinical practice of the Jakavi®-treatment in a broad patient population. In order to evaluate the direct effect of Jakavi®, only JAK inhibitor naive patients were documented in the first study arm; patients pretreated with JAK inhibitors were documented in the second study arm to evaluate the long-term efficacy of Jakavi® in this subpopulation.
The documentation of all patients was carried out prospectively and began after the baseline visit. The medical decision on which therapeutic and diagnostic measures to take was made solely by the responsible physician. The observational period per patient was 36 months. The visit schedule after the baseline visit was set by the responsible physician according to standard clinical care, the clinical condition of the respective patients and the SmPC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: JAK inhibitor naive | – | Other: JakaviJAK-inhibitor-naive patients, treatment start with ruxolitinib less than 14 days prior to the baseline visit |
| Arm B: Pretreated patients | – | Other: JakaviPatients pretreated with a JAK-inhibitor for more than 14 days prior to the baseline visit |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia Myelofibrosis (PET-MF), for whom Jakavi® therapy is indicated.
Key inclusion criteria (2 listed)
- Male and female patients with Primary Myelofibrosis (PMF), post-Polycythemia Vera-Myelofibrosis (PPV-MF), or post-Essential Thrombocythemia-Myelofibrosis (post-ET-MF), for whom Jakavi® therapy is indicated.
- Patients that were informed about all aspects of this NIS and provided written informed consent.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JakaviAlso: RuxolitinibProspective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC. | Other | Arm A: JAK inhibitor naive, Arm B: Pretreated patients |
Primary outcome
Safety and tolerability
Time frame: Up to 36 months
Evaluation of all occurring adverse events, serious adverse events and serious and non-serious adverse drug reactions
Spleen size (or volume) reduction
Time frame: Up to 36 months
Spleen size (or volume) reduction was measured by palpation
Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: Up to 36 months
The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The grade ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead).
Change in the number of patients with constitutional symptoms
Time frame: Up to 36 months
Number of patients with change in constitutional symptoms was collected
Assessment of the Quality of Life (QoL) - Myeloproliferative Neoplasm - Symptom Assessment Form (MPN-SAF)
Time frame: Baseline, month 1, month 3, month 6, month 12, month 24 and month 36
The MPN-SAF questionnaire contains important questions that cover MF-specific symptoms whose analysis is part of the standard of care. It includes disease related symptoms each scored from 0 (absent) to 10 (worst imaginable). Total Scores range from 0-100, with higher scores indicating a greater number of symptoms and severity.
Assessment of the Quality of Life (QoL) - Short Form-36 (SF-36)
Time frame: Baseline month 6, month 12, month 24 and month 36
This questionnaire consists of questions measuring physical function, physical role limitation, pain, general health, vitality, social function, emotional role limitations, and mental health status. The scores that can be obtained from the scale vary between 0 and 100 and the increase in the scores indicates that the quality of life is high.
Overall survival
Time frame: Up to 36 months
Overall survival for JAK inhibitor naive and pretreated patients
Ruxolitinib start and end dose
Time frame: Up to 36 months
Ruxolitinib start and end dose was collected
Therapy discontinuation and dose adjustments
Time frame: Up to 36 months
Number of participants with therapy discontinuation and dose adjustments was collected
Number of patients with co-morbidities
Time frame: Up to 36 months
Number of patients with co-morbidities was collected
Blood transfusion dependency
Time frame: Up to 36 months
Number of patients with blood transfusion dependency was collected
Number of patients with concomitant medications
Time frame: Up to 36 months
Number of patients with concomitant medications prescribed for myelofibrosis therapy and for the management of side effects was collected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 40619737Koschmieder S, Isfort S, Schulte C, Jacobasch L, Geer T, Reiser M, Koenigsmann M, Heinrich B, Wehmeyer J, von der Heyde E, Tesch H, Groschl B, Bachhuber P, Grosser S, Koehler M, Pahl HL. Final Results From a Large, Non-Interventional, Phase 4 Study of Ruxolitinib for the Treatment of Myelofibrosis in Clinical Routine. Eur J Haematol. 2025 Oct;115(4):380-390. doi: 10.1111/ejh.70005. Epub 2025 Jul 6.
- Derived from this study: PubMed 37792065Koschmieder S, Isfort S, Schulte C, Jacobasch L, Geer T, Reiser M, Koenigsmann M, Heinrich B, Wehmeyer J, von der Heyde E, Tesch H, Groschl B, Bachhuber P, Grosser S, Pahl HL. Real-world analysis of ruxolitinib in myelofibrosis: interim results focusing on patients who were naive to JAK inhibitor therapy treated within the JAKoMo non-interventional, phase IV trial. Ann Hematol. 2023 Dec;102(12):3383-3399. doi: 10.1007/s00277-023-05458-1. Epub 2023 Oct 4.
- Results for CINC424ADE05 that is getting linked from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Myelofibrosis and Post-polycythemia Vera Myelofibrosis, run by Novartis Pharmaceuticals at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Up to 36 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05044026, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.