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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00780455 |
Studying the effectiveness of a functional rehabilitation protocol (FRP) in early RRMS patients treated with Betaferon by comparing the physical ability of patients with and without FRP.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis, Relapsing-Remitting |
Drug: Interferon beta-1b (Betaseron, BAY86-5046) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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® |
Estimated Enrollment: | 70 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Active Comparator |
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Treatment by Betaferon for 3month and beginning of the Functional Rehabilitation Program as of V0 during 6 weeks
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Arm 2: Active Comparator |
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Treatment by Betaferon for 3month and beginning of the Functional Rehabilitation Program 6 weeks after the beginning of treatment
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trial Contact | clinical-trials-contact@bayerhealthcare.com | |
Contact: For trial location information (Phone Menu Options '3' or '4') | (+)1-888-84 22937 |
France | |
Not yet recruiting | |
Toulouse, France, 31059 | |
Not yet recruiting | |
Montpellier, France, 34295 | |
Not yet recruiting | |
Nimes, France, 30029 | |
Not yet recruiting | |
QUIMPER, France, 29000 | |
Recruiting | |
MULHOUSE, France, 68051 | |
Not yet recruiting | |
LOMME, France, 59160 | |
Not yet recruiting | |
Reims Cedex, France, 51091 | |
Not yet recruiting | |
Lille, France, 59037 | |
Not yet recruiting | |
AVIGNON, France, 84025 | |
France, Bretagne | |
Not yet recruiting | |
Rennes, Bretagne, France, 35038 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head ) |
Study ID Numbers: | 13089, EudraCT No 2006-006673-24, 308083 |
Study First Received: | May 28, 2008 |
Last Updated: | April 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00780455 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; United States: Food and Drug Administration |
KineSEP Rehabilitation Betaferon |
Autoimmune Diseases Demyelinating Diseases Immunologic Factors Interferons Interferon-beta Adjuvants, Immunologic Sclerosis |
Multiple Sclerosis, Relapsing-Remitting Antiviral Agents Multiple Sclerosis Interferon beta-1b Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Autoimmune Diseases Immunologic Factors Demyelinating Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Interferons Adjuvants, Immunologic Interferon-beta |
Sclerosis Antiviral Agents Multiple Sclerosis, Relapsing-Remitting Pharmacologic Actions Multiple Sclerosis Pathologic Processes Therapeutic Uses Interferon beta-1b Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |