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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006673-24 | EudraCT Number | ||
| 308083 | Other Identifier | Company internal |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interferon beta-1b, FRP within 15 days after randomization | Experimental | 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, FRP about 6 weeks after randomization | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b, FRP within 15 days after randomization | Drug | Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization |
| 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 |
| 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". |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes | Brittany Region | 35038 | France | |||
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Only 4 patients enrolled / 70 patients planned. Study stopped prematurely
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test. | Due to the very low number of patients enrolled in the study, no statistical report was done. | Posted | Up to 6 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (16.0) | Non-systematic Assessment |
Due to the very low number of patients enrolled in the study, no statistical report was done. Study was early terminated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affiars Therapeutic Area Head | Bayer Healthcare AG | clinical-trials-contact@bayerhealthcare.com |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| Interferon beta-1b, FRP about 6 weeks after randomization | Drug | Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks 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 |
| Avignon |
| 84025 |
| France |
| Lille | 59037 | France |
| Lomme | 59160 | France |
| Montpellier | 34295 | France |
| Mulhouse | 68051 | France |
| Nîmes | 30029 | France |
| Quimper | 29000 | France |
| Reims | 51091 | France |
| Toulouse | 31059 | France |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Time of Discomfort Appearance | Due to the very low number of patients enrolled in the study, no statistical report was done. | Posted | Up to 6 minutes |
|
|
| Primary | Distance of Discomfort Appearance | Due to the very low number of patients enrolled in the study, no statistical report was done. | Posted | Up to 6 minutes |
|
|
| Primary | Rhythm Change During 6 Minutes Walking Test | Due to the very low number of patients enrolled in the study, no statistical report was done. | Posted | Up to 6 minutes |
|
|
| 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". | Due to the very low number of patients enrolled in the study, no statistical report was done. | Posted | At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit) |
|
|
| 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. | Due to the very low number of patients enrolled in the study, no statistical report was done. | Posted | At baseline and 12 weeks after MR1 visit |
|
|
| 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. | Due to the very low number of patients enrolled in the study, no statistical report was done. | Posted | At baseline and 12 weeks after MR1 visit |
|
|
| 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". | Due to the very low number of patients enrolled in the study, no statistical report was done. | Posted | At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit) |
|
|
| 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. | Due to the very low number of patients enrolled in the study, no statistical report was done. | Posted | From baseline to 12 weeks after MR1 visit |
|
|
| 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. | Due to the very low number of patients enrolled in the study, no statistical report was done. | Posted | From baseline to 12 weeks after MR1 visit |
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | 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. | 0 | 2 | 2 | 2 |
| Otitis external ear | Ear and labyrinth disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Mood trouble | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA (16.0) | Non-systematic Assessment | transaminases increase |
|
| Visual acuity reduced | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Urinary tract infections | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
| Tooth Extraction | General disorders | MedDRA (16.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
|
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| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |