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Rehabilitation Study in MS Patients
This study is currently recruiting participants.
Verified by Bayer, April 2009
First Received: May 28, 2008   Last Updated: April 27, 2009   History of Changes
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00780455
  Purpose

Studying the effectiveness of a functional rehabilitation protocol (FRP) in early RRMS patients treated with Betaferon by comparing the physical ability of patients with and without FRP.


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

MedlinePlus related topics: Multiple Sclerosis Rehabilitation
Drug Information available for: Interferon beta Interferon-beta Interferon beta-1b Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®

Further study details as provided by Bayer:

Primary Outcome Measures:
  • The principal evaluation criterion is the covered distance during a walking test of 6 minutes (6MWT). [ Time Frame: 6 weeks after starting the functional rehabilitation program ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Persistence of the effect on 6 minute walk test, isokinetics of the knee and posturography [ Time Frame: 6 weeks after the end of the Functional Rehabilitation Program ] [ Designated as safety issue: No ]
  • Isokinetics of the knee (muscular strength) [ Time Frame: 6 weeks after starting functional rehabilitation ] [ Designated as safety issue: No ]
  • Posturography [ Time Frame: 6 weeks after starting functional rehabilitation ] [ Designated as safety issue: No ]
  • Fatigue using FSS questionaire [ Time Frame: 6 weeks after starting functional rehabilitation. ] [ Designated as safety issue: No ]
  • Quality of life using SEP 59 questionaire [ Time Frame: 6 weeks after starting functional rehabilitation. ] [ Designated as safety issue: No ]
  • Number of AEs and SAEs reported [ Time Frame: During the whole study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: October 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Active Comparator Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Treatment by Betaferon for 3month and beginning of the Functional Rehabilitation Program as of V0 during 6 weeks
Arm 2: Active Comparator Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Treatment by Betaferon for 3month and beginning of the Functional Rehabilitation Program 6 weeks after the beginning of treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and Male patients aged 18 and more;
  • Confirmed diagnosis of RRMS according to the MacDonald or Poser criteria;
  • First indication for Betaferon treatment (as described in SmPC);
  • No relapse of MS in the last two months before the inclusion;
  • Walking patients having an EDSS score between > 1 and </= 4 at the inclusion visit;
  • Female of child-bearing potential must agree to practice adequate contraception methods over all the duration of the study;
  • Patient can follow all the study and comply with all procedures of the trial protocol
  • Laboratory evaluations (i.e. evaluation of hepatic enzymes gammaGT, full blood count and differential WBC) must be available and the results must be normal;
  • Written informed consent.

Exclusion Criteria:

  • Any contraindication to Betaferon as described in the SmPC of the product;
  • Patient with a previously orthopaedic surgical intervention within the past year of the inclusion;
  • Patient previously included in this study;
  • Patient previously treated within the past 3 months with Rebif, Avonex or Copaxone;
  • Patient previously treated within the past 12 months with Betaferon;
  • Participation in any clinical trial within the past 30 days involving the investigational drug intake.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780455

Contacts
Contact: Bayer Clinical Trial Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
France
Not yet recruiting
Toulouse, France, 31059
Not yet recruiting
Montpellier, France, 34295
Not yet recruiting
Nimes, France, 30029
Not yet recruiting
QUIMPER, France, 29000
Recruiting
MULHOUSE, France, 68051
Not yet recruiting
LOMME, France, 59160
Not yet recruiting
Reims Cedex, France, 51091
Not yet recruiting
Lille, France, 59037
Not yet recruiting
AVIGNON, France, 84025
France, Bretagne
Not yet recruiting
Rennes, Bretagne, France, 35038
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers: 13089, EudraCT No 2006-006673-24, 308083
Study First Received: May 28, 2008
Last Updated: April 27, 2009
ClinicalTrials.gov Identifier: NCT00780455     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency;   United States: Food and Drug Administration

Keywords provided by Bayer:
KineSEP
Rehabilitation
Betaferon

Study placed in the following topic categories:
Autoimmune Diseases
Demyelinating Diseases
Immunologic Factors
Interferons
Interferon-beta
Adjuvants, Immunologic
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Antiviral Agents
Multiple Sclerosis
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

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

ClinicalTrials.gov processed this record on May 07, 2009