Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
KineSEP, Rehabilitation, Betaferon
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.
Interventions
DRUGInterferon 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
DRUGInterferon 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.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS) | From baseline to 12 weeks after MR1 visit | 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. |
| Covered Distance Gain Between MR2 Visit and MR3 Visit | At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 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. |
| Quality of Life Assessed by Use of Self-questionnaire (SEP-59) | From baseline to 12 weeks after MR1 visit | 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. |
| Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit | At 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 | At 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 | At MR2 visit (6 weeks after MR1 visit) and MR3 visit (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. This outcome was only measured on patients in the group Interferon beta-1b, FRP within 15 days after randomization. |
Countries
France
Participant flow
Recruitment details
Only 4 patients enrolled / 70 patients planned. Study stopped prematurely
Participants by arm
| Arm | Count |
|---|---|
| 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. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation. | 2 |
| 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. The FRP consisted of an intensive program over 6 weeks of effort and muscular reinforcement rehabilitation. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Interferon Beta-1b, FRP Within 15 Days After Randomization | Interferon Beta-1b, FRP About 6 Weeks After Randomization | Total |
|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 16.3 | 45 years STANDARD_DEVIATION 15.6 | 42.3 years STANDARD_DEVIATION 13.4 |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Distance of Discomfort Appearance
Time frame: Up to 6 minutes
Population: Due to the very low number of patients enrolled in the study, no statistical report was done.
Primary
Rhythm Change During 6 Minutes Walking Test
Time frame: Up to 6 minutes
Population: Due to the very low number of patients enrolled in the study, no statistical report was done.
Primary
Time of Discomfort Appearance
Time frame: Up to 6 minutes
Population: Due to the very low number of patients enrolled in the study, no statistical report was done.
Primary
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
Population: Due to the very low number of patients enrolled in the study, no statistical report was done.
Secondary
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.
Time frame: At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)
Population: Due to the very low number of patients enrolled in the study, no statistical report was done.
Secondary
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.
Time frame: At baseline and 12 weeks after MR1 visit
Population: Due to the very low number of patients enrolled in the study, no statistical report was done.
Secondary
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.
Time frame: From baseline to 12 weeks after MR1 visit
Population: Due to the very low number of patients enrolled in the study, no statistical report was done.
Secondary
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.
Time frame: At baseline and 12 weeks after MR1 visit
Population: Due to the very low number of patients enrolled in the study, no statistical report was done.
Secondary
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.
Time frame: At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)
Population: Due to the very low number of patients enrolled in the study, no statistical report was done.
Secondary
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.
Time frame: From baseline to 12 weeks after MR1 visit
Population: Due to the very low number of patients enrolled in the study, no statistical report was done.