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Rehabilitation Study in MS Patients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00780455
First received: May 28, 2008
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (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, FRP within 15 days after randomization
Drug: Interferon beta-1b, FRP about 6 weeks after randomization
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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®

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test. [ Time Frame: Up to 6 minutes ] [ Designated as safety issue: No ]
  • Time of Discomfort Appearance [ Time Frame: Up to 6 minutes ] [ Designated as safety issue: No ]
  • Distance of Discomfort Appearance [ Time Frame: Up to 6 minutes ] [ Designated as safety issue: No ]
  • Rhythm Change During 6 Minutes Walking Test [ Time Frame: Up to 6 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Covered Distance Gain Between MR2 Visit and MR3 Visit [ Time Frame: At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit) ] [ Designated as safety issue: No ]
    Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group "Interferon beta-1b, FRP within 15 days after randomization".

  • Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit [ Time Frame: At baseline and 12 weeks after MR1 visit ] [ Designated as safety issue: No ]
    The isokinetic evaluation analyses the flexor/extensor ratio at different rates. The evaluation will be done at the beginning on the best clinical side otherwise on the strongest. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.

  • Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit [ Time Frame: At baseline and 12 weeks after MR1 visit ] [ Designated as safety issue: No ]
    Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.

  • Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits [ Time Frame: At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit) ] [ Designated as safety issue: No ]
    Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance). Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1. This outcome was only measured on patients in the group "Interferon beta-1b, FRP within 15 days after randomization".

  • Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS) [ Time Frame: From baseline to 12 weeks after MR1 visit ] [ Designated as safety issue: No ]
    FSS is an auto-questionnaire estimating the fatigue. It includes 9 questions on 7 points as well as an analogical visual scale estimating the state of fatigue over the last two weeks. Participants had the following two types of visit during the study, one visit with a neurologist and one visit with a rehabilitation physician. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.

  • Quality of Life Assessed by Use of Self-questionnaire (SEP-59) [ Time Frame: From baseline to 12 weeks after MR1 visit ] [ Designated as safety issue: No ]
    SEP (Sclérose en plaques) - 59: auto-questionnaire, multidimensional investigating the felt health. It contains a generic part SF (Short Form) 36 constituted by 36 items including the main concepts of quality of life and a specific part to the MS which investigates the dimensions susceptible to be degraded. 59 items are grouped in 16 dimensions: physical activity, limitations bound connected to the physical health, to the mental health, the social well-being, the pain, the energy, the emotional well-being, general Health, distress, cognitive function sexual function/satisfaction, well-being general, sleep and social support. Visit to a neurologist: V0=baseline; V1=end of Month 1 of treatment; V2=end of Month 2 of treatment; V3=end of Month 3 of treatment. Visit to MR (Medecin Reeducateur: physician for rehabilitation): MR1=1st visit within 15 days after V0; MR2=2nd visit (6 weeks after MR1 +/- 1 week); MR3=end of study visit 12 weeks after MR1.


Enrollment: 4
Study Start Date: October 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interferon beta-1b, FRP within 15 days after randomization
Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization
Drug: Interferon beta-1b, FRP within 15 days after randomization
Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization
Experimental: Interferon beta-1b, FRP about 6 weeks after randomization
Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization
Drug: Interferon beta-1b, FRP about 6 weeks after randomization
Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.

  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 Summary of Product Characteristics (SmPC));
  • No relapse of multiple sclerosis (MS) in the last two months before the inclusion;
  • Walking patients having an Expanded Disability Status Scale (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 white blood cell [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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780455

Locations
France
Rennes, Bretagne, France, 35038
Avignon, France, 84025
Lille, France, 59037
Lomme, France, 59160
Montpellier, France, 34295
Mulhouse, France, 68051
Nimes, France, 30029
Quimper, France, 29000
Reims Cedex, France, 51091
Toulouse, France, 31059
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00780455     History of Changes
Other Study ID Numbers: 13089, 2006-006673-24, 308083
Study First Received: May 28, 2008
Results First Received: January 22, 2013
Last Updated: December 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Bayer:
KineSEP
Rehabilitation
Betaferon

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

ClinicalTrials.gov processed this record on November 25, 2014