Follow-up Study After 11 Years of Patients Who Were Included in the BE

BENEFIT 11 a Long-term Follow-up Study of the BENEFIT (Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment, 304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis

CompletedPhase 4Early (CIS/RIS)NCT017958722012-005262-35

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Several diagnostic procedures

What it measured

Main measures

  • Time to First Relapse by Kaplan-Meier Estimates

    Up to Year 11 (Day 3960)

    Relapses

  • Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates

    Up to Year 11 (Day 3960)

    Disability progressionRelapses

  • Number of Subjects With Diagnosis of Multiple Sclerosis Within Eleven years after Clinically-Isolated Syndrome (CIS) According to McDonald 2001 and 2010 Criteria

    Year 11

    RelapsesMRI lesions

  • Disease Course as Assessed at the Time of BENEFIT 11

    Year 11

    Disability progressionRelapsesMRI lesions

  • Percentage of Subjects Converting to Secondary Progressive Multiple Sclerosis (SPMS)

    Year 11

    Disability progressionRelapses

  • Time to Secondary Progressive Multiple Sclerosis (SPMS) Represented by Kaplan-Meier Estimates

    Up to Year 11 (Day 3960)

    Relapses

  • Expanded Disability Status Scale (EDSS) at Year 11

    Year 11

    Disability progression

  • Number of Subjects With Confirmed and Sustained 1-point Expanded Disability Status Scale (EDSS) Progression at Year 11

    Year 11

    Disability progression

  • Number of Subjects With Confirmed 2.5-point Expanded Disability Status Scale (EDSS) Progression at Year 11

    Year 11

    Disability progression

  • Percentage of Subjects who Ever Reached a Disability Status Scale (DSS) 3 and 6

    Year 11

    Disability progression

  • Disability Based Efficacy Domain: Time to Disability Status Scale (DSS) 3 by Kaplan-Meier Estimates

    Up to Year 11 (Day 3960)

    Disability progression

  • Disability Based Efficacy Domain: Time to Disability Status Scale (DSS) 6 by Kaplan-Meier Estimates

    Up to Year 11 (Day 3960)

    Disability progression

  • Multiple Sclerosis Functional Composite (MSFC) at Year 11

    Year 11

    Disability progressionThinking and memoryWalking and mobility

  • Multiple Sclerosis Severity Score (MSSS) at Year 11

    Year 11

    Disability progression

  • Cognitive Function: Paced Auditory Serial Addition Test-3 (PASAT-3) at Year 11

    Year 11

    Thinking and memory

  • Cognitive function: Symbol Digit Modalities Test (SDMT)

    Year 11

    Thinking and memory

  • Relapse-Based Efficacy domain: Hazard Ratio for Recurrent Relapses

    Year 11

    RelapsesMRI lesions

  • Relapse Based Efficacy Domain: Annualized Relapse Rate

    Year 11

    Relapses

  • Time to use of Ambulatory Device Represented by Kaplan-Meier Estimates

    Up to Year 11 (Day 3960)

  • Time to Dependence of Ambulatory Device for Walking Represented by Kaplan-Meier Estimates

    Up to Year 11 (Day 3960)

    Walking and mobility

  • Number of Subjects With Wheelchair Use After 11 years

    Year 11

  • Regular face-to-face site visit:

Other measures (30)

  • Education Status at Year 11

    Year 11

  • Living Conditions at Year 11

    Year 11

  • Employment Status at Year 11

    Year 11

  • Multiple Sclerosis Impact on Employment at Year 11

    Year 11

  • Resource Use: Hospitalization During Last 12 months

    Year 11

  • Resource Use: Visits to Other Specialists During Last 12 months

    Year 11

  • Resource Use Assessment Questionnaire: Help from Family/Regular Ambulatory Services

    Year 11

  • Resource Use Assessment Questionnaire: Additional Ambulatory Services During Relapse

    Year 11

    Relapses

  • Resource Use Assessment Questionnaire: Adaptions past 6 months

    Year 11

    Walking and mobility

  • Patient-Reported Outcomes (PRO)-based Efficacy Domain: Center of Epidemiological Studies Depression Scale (CES-D) Total Score at Year 11

    Year 11

    Mood and sleepQuality of life (reported by participants)

Who could take part

Early (CIS/RIS) · 18 and over

Show the full criteria

Inclusion criteria

* Male and female patients with clinical-isolated syndrome or multiple sclerosis who have been treated at least once in BENEFIT Study 304747

Exclusion criteria

* Patients who, according to the investigator's judgment, have medical, psychiatric, or other conditions that compromise the patient's ability to understand the purpose of the study

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.

Papers

Loading reviews and guidelines…

History

    1. Started

      Sept 2013

    2. Main results due

      Apr 2014

    3. Finished

      Jun 2014

    Assembled by software from public sources.