Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER)
- Conditions
- Mycosis Fungoides and Sézary Syndrome
- Registration Number
- NCT05455931
- Lead Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 73
Inclusion Criteria:<br><br> 1. Patient aged =18 years<br><br> 2. Confirmed diagnosis of MF/SS<br><br> 3. Disease staging at enrollment has been completed<br><br> 4. About to commence primary treatment with Poteligeo® as per reimbursed indication<br><br> 5. Patient is willing and able to complete the symptom diary and PROs.<br><br> 6. Patient is willing and able to provide written informed consent to participate in<br> the study in a manner approved by Institutional Review Board(IRB)/ Independent<br> Ethics Committee (IEC) and local regulations<br><br>Exclusion Criteria:<br><br> 1. Patient unable to participate in all aspects of the study and/or does not agree to<br> the collection of data from medical records<br><br> 2. Patient currently participating in an interventional clinical trial
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the patient-reported change in key signs and symptoms of disease following initiation of treatment with Poteligeo.;To describe the patient-reported change in fatigue following initiation of treatment with Poteligeo.;To describe the patient-reported change in health-related QoL following initiation of treatment with Poteligeo.;To assess change in the HRQoL of the patient's main caregiver
- Secondary Outcome Measures
Name Time Method