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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928967
• Other study ID #: 14168
• Secondary ID: Daily Life Study
• Status: Completed
• Phase: N/A
• First received: June 23, 2009
• Last updated: October 7, 2015
• Start date: May 2007
• Est. completion date: November 2010

Study information

• Verified date: October 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1b, (Betaseron BAY86-5046)
The cohort included is described in section 8.5 (inclusion criteria)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the Daily Life score: Analysis of variance for repeated measurements.		After 1, 3, 6, 9 and 12 months	No
Secondary	Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements		Over 12 months	No
Secondary	Correlation coefficient with quality of life scales		Over 12 months	No
Secondary	Kinetics of treatment discontinuation: Kaplan Meier		Over 12 months	No
Secondary	Rate of treatment continuation		After 12 months	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to marketed products.