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

NCT02386566 | Completed

• 1 other identifier: CHE-TYS-12-10341
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objective of the study is to determine the association between prospectively measured disability (Expanded Disability Status Scale \[EDSS\]) with quality of life (Multiple Sclerosis International Quality of Life Questionnaire \[MusiQoL\]) at 3-month intervals up to 1 year in a real life setting of multiple sclerosis (MS) patients treated with natalizumab. The secondary objectives of this study are as follows: To evaluate the cumulative probability of sustained EDSS changes at 1 year following natalizumab treatment initiation; To evaluate the association between disability (EDSS), fatigue (Fatigue Scale of Motor and Cognitive Function \[FSMC\]), sexual dysfunction (Multiple Sclerosis Intimacy and Sexuality Questionnaire-19 \[MSISQ-19\]), depression (Beck Depression Inventory-Fast Screen \[BDI-FS\]) and neurocognitive function (Symbol Digit Modalities Test \[SDMT\]) with EuroQol-5D Questionnaire (EQ-5D) at 3 to 6-months intervals up to 1 year after initiation of natalizumab treatment; To assess the relationship between clinical disease-free status (no EDSS increase of 1.0 and no relapse) and MusiQoL at 1 year following natalizumab treatment initiation; To record the number of clinical relapses and relapses requiring steroid treatment at 3-months intervals up to 1 year after initiation of natalizumab treatment; To describe changes in work impairment (Work Productivity and Activity Impairment in MS \[WPAI-MS\]) at 3-months intervals up to 1 year after initiation of natalizumab treatment; To describe any change in the percentage of disability pension and occupation after 1 year of natalizumab treatment; To record the incidence and number of Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR) throughout the study

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Compare EDSS change categories with changes in MusiQoL

  The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. The MusiQOL is a multidimensional Health Related Quality of Life (HRQoL) instrument that provides information based on the views and perceptions of the participants.

  At 1 year after initiating natalizumab treatment

Secondary Outcomes (12)

• Cumulative probabilities of sustained improvement and progression in neurological disability

  At 1 year after initiating natalizumab treatment

• Compare clinical disease-free status (no sustained EDSS increase of 1.0 and no relapse) with MusiQoL

  Up to 1 year after initiating natalizumab treatment

• Compare EDSS change categories with EQ-5D

  Up to 1 year after initiating natalizumab treatment

• Compare FSMC score with EQ-5D

  Up to 1 year after initiating natalizumab treatment

• Compare MSISQ-19 scores with EQ-5D

  Up to 1 year after initiating natalizumab treatment

Study Arms (1)

natalizumab

natalizumab 300 mg intravenous (IV) every 4 weeks; according to the approved product label of Tysabri in Switzerland

Drug: natalizumab

Interventions

natalizumab DRUG

As described in the treatment arm

Also known as: Tysabri, BG00002

natalizumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (7)

Research Site

Aarau, Switzerland

Location

Research Site

Basel, Switzerland

Location

Research Site

Bern, Switzerland

Location

Research site - private practice

Lucerne, Switzerland

Location

Research Site

Lugano, Switzerland

Location

Research Site

Wohlen, Switzerland

Location

Research Site

Zurich, Switzerland

Location

Related Publications (1)

• Achtnichts L, Zecca C, Findling O, Kamm CP, Mueller S, Kuhle J, Lutterotti A, Gobbi C, Viviani C, Villiger-Borter E, Nedeltchev K. Correlation of disability with quality of life in patients with multiple sclerosis treated with natalizumab: primary results and post hoc analysis of the TYSabri ImPROvement study (PROTYS). BMJ Neurol Open. 2023 Jan 26;5(1):e000304. doi: 10.1136/bmjno-2022-000304. eCollection 2023.

  PMID: 36727105 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: March 12, 2015
• Study Start: March 20, 2015
• Primary Completion: January 28, 2018
• Study Completion: January 28, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

CH (7)