Rehabilitation Study in MS Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: Interferon beta-1b, FRP within 15 days after randomization
* Drug: Interferon beta-1b, FRP about 6 weeks after randomization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interferon beta-1b, FRP within 15 days after randomization<br>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<br>* Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization<br>|
| Experimental: Interferon beta-1b, FRP about 6 weeks after randomization<br>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<br>* Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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KineSEP, Rehabilitation, Betaferon