Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02386566
• Date of registration: 06/02/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With Natalizumab PROTYS
• Scientific title: A Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With Natalizumab
• Date of first enrolment: March 20, 2015
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02386566
• Study type: Observational

Countries of recruitment

Switzerland

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Subjects that have a confirmed diagnosis of RRMS, as per the 2010 revised McDonald
criteria

- Subjects satisfying the therapeutic indication of natalizumab, as described in the
local product label and confirmed by the Investigator. (Patients with previous
treatment with natalizumab are also considered to be eligible only if the last
natalizumab infusion was at least 1 year before the screening visit of this study)

- Decision for a treatment with natalizumab has been made before screening

- Patients with an EDSS score of 2.0-5.5 (both limits inclusive)

Key Exclusion Criteria:

- Patients with a diagnosed co-existing brain pathology other than MS, which in the
judgement of the investigator impacts the value of EDSS or QoL.

- Pure spinal manifestation of demyelination

- Diagnosis of primary or secondary progressive MS

- Any change in concomitant medication known to affect cognition or bladder function

- A history of severe depressive disorder and/or suicidality, seizure, drug or alcohol
abuse, as assessed by the Investigator

NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: natalizumab

Primary Outcome(s)

Compare EDSS change categories with changes in MusiQoL [Time Frame: At 1 year after initiating natalizumab treatment]

Secondary Outcome(s)

Changes in the WPAI questionnaire [Time Frame: Up to 1 year after initiating natalizumab treatment]

Compare MSISQ-19 scores with EQ-5D [Time Frame: Up to 1 year after initiating natalizumab treatment]

Compare FSMC score with EQ-5D [Time Frame: Up to 1 year after initiating natalizumab treatment]

Compare SDMT scores with EQ-5D [Time Frame: Up to 1 year after initiating natalizumab treatment]

Cumulative probabilities of sustained improvement and progression in neurological disability [Time Frame: At 1 year after initiating natalizumab treatment]

Comparison of BDI-FS with EQ-5D [Time Frame: Up to 1 year after initiating natalizumab treatment]

Rates of clinical relapses and relapses requiring steroid treatment [Time Frame: Up to 1 year after initiating natalizumab treatment]

Change in the percentage of disability pension [Time Frame: At 1 year after initiating natalizumab treatment]

Incidence and number of SAEs and SUSARs [Time Frame: Up to 1 year after initiating natalizumab treatment]

Change in kind and percentage of occupation due to MS [Time Frame: At 1 year after initiating natalizumab treatment]

Compare clinical disease-free status (no sustained EDSS increase of 1.0 and no relapse) with MusiQoL [Time Frame: Up to 1 year after initiating natalizumab treatment]

Compare EDSS change categories with EQ-5D [Time Frame: Up to 1 year after initiating natalizumab treatment]

Secondary ID(s)

CHE-TYS-12-10341

Source(s) of Monetary Support

Please refer to primary and secondary sponsors