CompletedNot Applicable

A Prospective, Two-arm, Non-interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis

Germany1,012 participantsStarted 2012-09-20

Plain-language summary

This was a prospective, two-arm, non-interventional study of JAKAVI® (Ruxolitinib) in patients with myelofibrosis

Who can participate

Age range18 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: \-

What they're measuring

Safety and tolerability

Timeframe: Up to 36 months

Spleen size (or volume) reduction

Timeframe: Up to 36 months

Eastern Cooperative Oncology Group (ECOG) performance status

Timeframe: Up to 36 months

Change in the number of patients with constitutional symptoms

Timeframe: Up to 36 months

Assessment of the Quality of Life (QoL) - Myeloproliferative Neoplasm - Symptom Assessment Form (MPN-SAF)

Timeframe: 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)

Timeframe: Baseline month 6, month 12, month 24 and month 36

Overall survival

Timeframe: Up to 36 months

Ruxolitinib start and end dose

Timeframe: Up to 36 months

Trial details

NCT IDNCT05044026

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-19

View on ClinicalTrials.gov More Primary Myelofibrosis trials