Rehabilitation Study in MS Patients

Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Drug: Interferon beta-1b, FRP within 15 days after randomization; Drug: Interferon beta-1b, FRP about 6 weeks after randomization

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • 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
  • Bretagne
    • Rennes, Bretagne, France, 35038

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.	Up to 6 minutes
Time of Discomfort Appearance	Up to 6 minutes
Distance of Discomfort Appearance	Up to 6 minutes
Rhythm Change During 6 Minutes Walking Test	Up to 6 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Covered Distance Gain Between MR2 Visit and MR3 Visit	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".	At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)
Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit	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.	At baseline and 12 weeks after MR1 visit
Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit	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.	At baseline and 12 weeks after MR1 visit
Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits	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".	At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)
Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)	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.	From baseline to 12 weeks after MR1 visit
Quality of Life Assessed by Use of Self-questionnaire (SEP-59)	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.	From baseline to 12 weeks after MR1 visit

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: May 28, 2008
• First Submitted That Met QC Criteria: October 24, 2008
• First Posted (Estimate): October 27, 2008

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 8, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Rehabilitation; Betaferon; KineSEP
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon-beta; Interferon beta-1b
• Other Study ID Numbers: 13089; 2006-006673-24 (EudraCT Number); 308083 (Other Identifier: Company internal)