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OpenTrials
Completed

NCT Number: NCT00928967

Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients

To evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b treatment in patients presenting RRMS or patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event

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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

Observational

Primary location

Many Locations, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria
  • The choice of treatment must be clearly dissociated from the decision to include the patient in the study.

Treatment and study plan

Interferon beta-1b, (Betaseron BAY86-5046)

Drug

The cohort included is described in section 8.5 (inclusion criteria)

Primary outcomes

  1. Evolution of the Daily Life score: Analysis of variance for repeated measurements.

    Time frame: After 1, 3, 6, 9 and 12 months

Secondary outcomes

  1. Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements

    Time frame: Over 12 months

  2. Correlation coefficient with quality of life scales

    Time frame: Over 12 months

  3. Kinetics of treatment discontinuation: Kaplan Meier

    Time frame: Over 12 months

  4. Rate of treatment continuation

    Time frame: After 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 26, 2009
Registry last updated
Oct 9, 2015

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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