Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Registration Number
- NCT06567197
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria:<br><br> - All patients approved for treatment with aHSCT in the Netherlands in accordance with<br> the Dutch criteria for aHSCT treatment for RRMS<br><br>Exclusion Criteria:<br><br> - Contra-indications for treatment with aHSCT such as known hypersensitivity to the<br> medication used for aHSCT<br><br> - Clinically relevant comorbidities preventing safe use of medication used for aHSCT<br><br> - Severe clinical depression<br><br> - Active addiction to drugs or alcohol<br><br> - Active infections such as but not limited to tuberculosis, cytomegalovirus,<br> Epstein-Barr virus, herpes simplex, varicella zoster, viral hepatitis,<br> toxoplasmosis, HIV or syphilis.<br><br> - Active malignancy or history of malignancy with the exception of local basal cell<br> carcinoma or carcinoma in situ of the cervix
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment efficacy
- Secondary Outcome Measures
Name Time Method Annual relapse rate;Time to first relapse;Confirmed disability progression (CDP);Confirmed disability improvement (CDI);Progression independent of relapse activity (PIRA);Changes on the multiple sclerosis functional composite (MSFC);Brain/spinal cord MRI;Optical coherence tomography (OCT);Side-effects and toxicity;Multiple Sclerosis Impact Scale-29 (MSIS-29);EuroQoL 5D (EQ-5D-5L);Modified Fatigue Impact Scale (MFIS-5);Hospital Anxiety and Depression Scale (HADS);iMTA Medical Cost Questionnaire (iMCQ);iMTA Productivity Cost Questionnaire (iPCQ);Treatment Satisfaction Questionnaire for Medication (TSQM);Biomarkers;Proteomics;Immune phenotyping;Genetic analysis