Trial record 6 of 19 for:    Tysabri | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT02386566
First received: February 6, 2015
Last updated: December 10, 2015
Last verified: December 2015
  Purpose
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

Condition Intervention
Multiple Sclerosis
Drug: natalizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With Natalizumab

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Compare EDSS change categories with changes in MusiQoL [ Time Frame: At 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cumulative probabilities of sustained improvement and progression in neurological disability [ Time Frame: At 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Compare EDSS change categories with EQ-5D [ Time Frame: Up to 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
    The EQ-5D is a two-part instrument that consists of the following administered together: 1) EQ-5D-5L- The descriptive system comprises the same 5 dimensions as the EQ-5D-3L (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ-VAS describes the respondent's self-rated health on a vertical visual analog scale (VAS).

  • Compare FSMC score with EQ-5D [ Time Frame: Up to 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
    FSMC provides differential quantification and graduation of cognitive and motor fatigue. The total score ranges from 0 to 100 with higher scores indicating more fatigue.

  • Compare MSISQ-19 scores with EQ-5D [ Time Frame: Up to 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
    MSIS-Q is a 19-question survey to assess sexual QoL in MS patients. The scoring is based on a scale ranging from 1 (never interfered with my sexual activity or satisfaction) to 5 (always interfered with my sexual activity or satisfaction).

  • Comparison of BDI-FS with EQ-5D [ Time Frame: Up to 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
    The Beck Depression Inventory (BDI) as measured by the BDI-FS is a 7-item multiple-choice self-report inventory for measuring the severity of depression in MS.

  • Compare SDMT scores with EQ-5D [ Time Frame: Up to 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
    SDMT is a screening test for cognitive impairment. It assesses key neurocognitive functions that underlie many substitution tasks, including attention, visual scanning, and motor speed. SDMT scores are highly correlated to Magnetic Resonance Imaging (MRI) derived measures of disease burden and disability progression in MS patients.

  • Rates of clinical relapses and relapses requiring steroid treatment [ Time Frame: Up to 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
  • Changes in the WPAI questionnaire [ Time Frame: Up to 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
    The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

  • Change in kind and percentage of occupation due to MS [ Time Frame: At 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
  • Change in the percentage of disability pension [ Time Frame: At 1 year after initiating natalizumab treatment ] [ Designated as safety issue: No ]
  • Incidence and number of SAEs and SUSARs [ Time Frame: Up to 1 year after initiating natalizumab treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 88
Study Start Date: March 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
natalizumab
natalizumab 300 mg intravenous (IV) every 4 weeks; according to the approved product label of Tysabri in Switzerland
Drug: natalizumab
As described in the treatment arm
Other Names:
  • Tysabri
  • BG00002

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care.
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02386566

Contacts
Contact: Biogen clinicaltrials@biogen.com

Locations
Switzerland
Research Site Recruiting
Aarau, Switzerland
Research Site Recruiting
Bern, Switzerland
Research Site Recruiting
Lugano, Switzerland
Research Site Recruiting
Luzern, Switzerland
Research Site Not yet recruiting
Muensterlingen, Switzerland
Research Site Recruiting
St. Gallen, Switzerland
Research Site Recruiting
Wohlen, Switzerland
Research Site Recruiting
Zurich, Switzerland
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02386566     History of Changes
Other Study ID Numbers: CHE-TYS-12-10341 
Study First Received: February 6, 2015
Last Updated: December 10, 2015
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 24, 2016