Relapsing remitting multiple sclerosis (RMS) Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Non-interventional, observational study
diagnosis and treatment are done only in compliance with clinical routine
This is a multicenter, prospective, observational, single-cohort study to document utilization, effectiveness
however, before their fourth dose of daclizumab at the latest.
Assessments will be completed and data collected at baseline, 3 and 6 months after initiation of daclizumab treatment an
Sponsors
Biogen GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to understand the purpose of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations 2. Start of daclizumab therapy in accordance with local prescribing information; the decision for the daclizumab therapy must be made before study inclusion; patients can be enrolled until before administration of fourth daclizumab dose - provided baseline data are available 3. Aged at least 18 years at time of enrolment; no upper age limit
Exclusion criteria
Exclusion criteria: 1. Missing ability or willingness to give informed consent after information about the study 2. Missing eligibility for participation from physician's point of view 3. Contraindication to treatment with daclizumab or diseases which are contraindicated according to the local prescribing information 4. Concomitant therapy with another disease-modifying MS-therapy 5. Current or planned participation in a clinical interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who are on treatment with daclizumab at Month 24 after treatment initiation (current therapy is documented at each visit: baseline, 3 months, 6 months, and every 6 months until month 60) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who are on treatment with daclizumab at Month 60 after treatment initiation (current therapy is documented at each visit) 2. Reasons for stopping a therapy with daclizumab (if applicable); therapy is documented at each visit 3. Therapy adherence, self reported by patients in a diary and documented by participating physician at each visit 4. Relapse rates per year and percentage of patients without relapse; time until first relapse; relapses are documented at each visit 5. Progression of disability (24 weeks after start of therapy), measured by EDSS score 6. AEs and SAEs, documented at each visit 7. Complete blood count, lymphocyte sub-populations, measured at each visit 8. Patient reported outcomes: 8.1. Patients’ views regarding consequences of MS, measured using Multiple Sclerosis Impact Scale (MSIS-29) 8.2. Quality of life, measured using EuroQoL-5D (EQ-5D) 8.3. Treatment satisfaction, measured using Treatment Satisfaction Questionnaire for Medication (TSQM 1.4) 8.4. Cognitive functions, measured using the Symbol Digit Modalities Test (SDMT) Visits take place at baseline, 3 months, 6 months, and every 6 months until month 60 | — |
Countries
Germany
Outcome results
None listed