Back to resultsRehabilitation Study in MS Patients
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Interferon beta-1b, FRP within 15 days after randomization
Interferon beta-1b, FRP about 6 weeks after randomization
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring KineSEP, Rehabilitation, Betaferon
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Interferon beta-1b, FRP within 15 days after randomization
Interferon beta-1b, FRP about 6 weeks after randomization
Arm Description
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
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
Outcomes
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 of Discomfort Appearance
Distance of Discomfort Appearance
Rhythm Change During 6 Minutes Walking Test
Secondary Outcome Measures
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".
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.
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.
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".
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00780455
Brief Title
Rehabilitation Study in MS Patients
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®
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
KineSEP, Rehabilitation, Betaferon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interferon beta-1b, FRP within 15 days after randomization
Arm Type
Experimental
Arm Description
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
Arm Title
Interferon beta-1b, FRP about 6 weeks after randomization
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1b, FRP within 15 days after randomization
Intervention Description
Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1b, FRP about 6 weeks after randomization
Intervention Description
Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.
Primary Outcome Measure Information:
Title
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
Title
Time of Discomfort Appearance
Time Frame
Up to 6 minutes
Title
Distance of Discomfort Appearance
Time Frame
Up to 6 minutes
Title
Rhythm Change During 6 Minutes Walking Test
Time Frame
Up to 6 minutes
Secondary Outcome Measure Information:
Title
Covered Distance Gain Between MR2 Visit and MR3 Visit
Description
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".
Time Frame
At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)
Title
Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit
Description
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.
Time Frame
At baseline and 12 weeks after MR1 visit
Title
Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit
Description
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.
Time Frame
At baseline and 12 weeks after MR1 visit
Title
Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits
Description
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".
Time Frame
At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)
Title
Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)
Description
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.
Time Frame
From baseline to 12 weeks after MR1 visit
Title
Quality of Life Assessed by Use of Self-questionnaire (SEP-59)
Description
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.
Time Frame
From baseline to 12 weeks after MR1 visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35038
Country
France
City
Avignon
ZIP/Postal Code
84025
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Lomme
ZIP/Postal Code
59160
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Mulhouse
ZIP/Postal Code
68051
Country
France
City
Nimes
ZIP/Postal Code
30029
Country
France
City
Quimper
ZIP/Postal Code
29000
Country
France
City
Reims Cedex
ZIP/Postal Code
51091
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Learn more about this trial
Rehabilitation Study in MS Patients
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