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Completed

NCT Number: NCT03269175

BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies

The purpose of this study is to obtain long-term clinical data from patients approximately 15 years after their first clinical event, who participated in the former BENEFIT 304747 study and were treated at least once within that study.

This study will collect clinical information on the disease course, on disability, relapses, cognitive function over time, quality of life, depression, fatigue, resource use, and employment status. In addition, brain MRI is performed.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinische Universität Graz, Graz, Styria, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study

Exclusion criteria

  • Subjects who, according to the investigator's judgment, have medical, psychiatric, or other conditions that compromise the subject's ability to understand the purpose of the study
  • Suspected clinical instability or unpredictability of the clinical course during the study(e.g., due to previous surgery or acute stroke)

Treatment and study plan

Brain MRI

Other

Brain MRI will be performed

Blood sampling

Other

Blood samples will be taken

Primary outcomes

  1. Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria

    Time frame: Over 15 years since the subject´s first clinical event

  2. Disease course since start of BENEFIT as assessed at the time of BENEFIT 15

    Time frame: Over 15 years since the subject's first clinical event

  3. Time to first relapse

    Time frame: Over 15 years since the subject´s first clinical event

  4. Time to recurrent relapse

    Time frame: Over 15 years since the subject´s first clinical event

  5. Annualized relapse rate

    Time frame: Over 15 years since the subject´s first clinical event

  6. Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)

    Time frame: Over 15 years since the subject´s first clinical event

  7. Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)

    Time frame: Over 15 years since the subject´s first clinical event

  8. Expanded Disability Status Scale these scores (EDSS score) for disability assessed by the investigator during the neurological examination

    Time frame: 15 years after the subject´s first clinical event

  9. Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)

    Time frame: Over 15 years since the subject´s first clinical event

  10. Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)

    Time frame: Over 15 years since the subject´s first clinical event

  11. Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)

    Time frame: Over 15 years since the subject´s first clinical event

    MSFC: Multiple Sclerosis Functional Composite

  12. Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)

    Time frame: Over 15 years since the subject´s first clinical event

  13. Time to use of ambulatory device

    Time frame: Over 15 years since the subject´s first clinical event

  14. Time to dependence on ambulatory device

    Time frame: Over 15 years since the subject´s first clinical event

  15. Time to use of wheelchair

    Time frame: Over 15 years since the subject´s first clinical event

  16. Employment status (Standardized questions)

    Time frame: At one single visit, 15 years after the subject's first clinical event

    The current employment will be recorded

  17. Multiple sclerosis impact on employment

    Time frame: At one single visit, 15 years after the subject's first clinical event

  18. Resource use assessment questions: Help from family/regular ambulatory services

    Time frame: At one single visit, 15 years after the subject's first clinical event

  19. Resource use assessment questions: Additional ambulatory services during relapse

    Time frame: At one single visit, 15 years after the subject's first clinical event

  20. Resource use assessment questions: Adaptions (past 6 months)

    Time frame: At one single visit, 15 years after the subject's first clinical event

Secondary outcomes

  1. Symbol Digit Modalities Test score (SDMT score)

    Time frame: At one single visit, 15 years after the subject's first clinical event

    SDMT: Symbol Digit Modalities Test, Cognitive test

    For sustained attention, concentration and information processing speed

  2. Relation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions)

    Time frame: At one single visit, 15 years after the subject's first clinical event

  3. Relation of mental processing speed and MRI parameters

    Time frame: At one single visit, 15 years after the subject's first clinical event

  4. European Quality of life - 5 Dimensions Health-related Quality of life (EQ-5D HRQoL) score

    Time frame: Over 15 years since the subject´s first clinical event

    EQ-5D: European Quality of Life - 5 dimensions Questionnaire measuring health-related quality of life

  5. European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score

    Time frame: Over 15 years since the subject's first clinical event

  6. Functional Assessment of Multiple Sclerosis (FAMS score)

    Time frame: Over 15 years since the subject´s first clinical event

    FAMS: Functional Assessment of Multiple Sclerosis

    Questionnaire measuring health-related quality of life

  7. Fatigue Scale for Motor and Cognitive Functions (FSMC score)

    Time frame: At one single visit, 15 years after the subject's first clinical event

  8. Center of Epidemiological Studies for Depression (CES-D) score

    Time frame: At one single visit, 15 years after the subject's first clinical event

  9. Time to second line therapy

    Time frame: Over 15 years since the subject´s first clinical event

  10. Time to first disease-modifying therapies (DMT) other than IFNB-1b

    Time frame: Over 15 years since the subject´s first clinical event

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2017
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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