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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00928967
First received: June 23, 2009
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention
Multiple Sclerosis
 Drug: Interferon beta-1b, (Betaseron BAY86-5046)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Evolution of the Daily Life score: Analysis of variance for repeated measurements. [ Time Frame: After 1, 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Correlation coefficient with quality of life scales [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Kinetics of treatment discontinuation: Kaplan Meier [ Time Frame: Over 12 months ] [ Designated as safety issue: No ]
  • Rate of treatment continuation [ Time Frame: After 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

n.a.


Enrollment: 68
Study Start Date: May 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b, (Betaseron BAY86-5046)
The cohort included is described in section 8.5 (inclusion criteria)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928967

Locations
France
Many Locations, France
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00928967     History of Changes
Other Study ID Numbers: 14168, Daily Life Study, BF0610FR
Study First Received: June 23, 2009
Last Updated: January 24, 2012
Health Authority: France: French Data Protection Authority

Keywords provided by Bayer:
Multiple Sclerosis
Quality of life

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta-1b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on June 17, 2013