An observational study in Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis and Post-essential Thrombocythemia Myelofibrosis, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Germany. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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Among 24 studies in Primary Myelofibrosis by Novartis — 1 open to participants now, 4 under way, 2 of them phase 3. Primary Myelofibrosis · Novartis.
Among the 24 studies in Primary Myelofibrosis by Novartis, this one is one of 3 that started in 2012, is one of 2 observational ones, and was the 21st registered.
626 studies on the registry are indexed under Primary Myelofibrosis; 125 are open to participants now.
Browse Primary Myelofibrosis studies →1 of the 24 studies in Primary Myelofibrosis by Novartis is open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States, Argentina, Australia and 21 more countries
Ages 18+
By country, each count listing its studies:
Of the 102 Primary Myelofibrosis studies recruiting now, 84 (82%) set no upper age limit and 13 (13%) stop at 75 or younger; 10 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 120 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 7 · Phase 3 7 · Phase 4 2
First in 2001; this study’s year is marked. 3 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,012 is above the median of 125 across 73 observational studies indexed under Primary Myelofibrosis.
Median enrollment 51 across the 21 interventional studies, 684 across the 2 observational. Of the 18 that completed or were terminated, 12 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 24 studies in Primary Myelofibrosis by Novartis, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This was a prospective, two-arm, non-interventional study of JAKAVI® (Ruxolitinib) in patients with myelofibrosis
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.
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.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
JAK-inhibitor-naive patients, treatment start with ruxolitinib less than 14 days prior to the baseline visit
Other: Jakavi
Patients pretreated with a JAK-inhibitor for more than 14 days prior to the baseline visit
Other: Jakavi
Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.
Also known as: Ruxolitinib
Safety and tolerability
Evaluation of all occurring adverse events, serious adverse events and serious and non-serious adverse drug reactions
Time frame: Up to 36 months
Spleen size (or volume) reduction
Spleen size (or volume) reduction was measured by palpation
Time frame: 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).
Time frame: Up to 36 months
Change in the number of patients with constitutional symptoms
Number of patients with change in constitutional symptoms was collected
Time frame: 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.
Time frame: 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.
Time frame: Baseline month 6, month 12, month 24 and month 36
Overall survival
Overall survival for JAK inhibitor naive and pretreated patients
Time frame: Up to 36 months
Ruxolitinib start and end dose
Ruxolitinib start and end dose was collected
Time frame: Up to 36 months
Therapy discontinuation and dose adjustments
Number of participants with therapy discontinuation and dose adjustments was collected
Time frame: Up to 36 months
Number of patients with co-morbidities
Number of patients with co-morbidities was collected
Time frame: Up to 36 months
Blood transfusion dependency
Number of patients with blood transfusion dependency was collected
Time frame: 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
Time frame: Up to 36 months
Plan to share: No
Ran from Sep 2012 to primary completion in Sep 2022, 119 months.
Of 23 observational studies under Primary Myelofibrosis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 119. This study's 119 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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