Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00317941 |
The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.
Condition | Intervention | Phase |
---|---|---|
Relapsing-Remitting Multiple Sclerosis |
Drug: Betaferon/Betaseron Drug: Rebif |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Etude de Phase IV, Multicentrique, randomisée, Ouverte, Comparant Les réactions et la Douleur Aux Sites d'Injection après Administration Sous-cutanée d'interféron bêta-1b (Betaferon) ou interféron bêta-1a (Rebif) Pendant la période de Trois Mois d'Initiation de la thérapie Chez Des Patients à Haut Risque de développer Une sclérose en Plaques ou Atteints d'Une Forme récurrente/rémittente de sclérose en Plaques AVANTAGE: Analyse Comparative Des réactions Aux Sites d'Injection surVenues après AdministratioN de BeTAferon250 µG ou REbif 44 µg. |
Enrollment: | 220 |
Study Start Date: | March 2006 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator |
Drug: Betaferon/Betaseron
250ug administrated with Betaject
|
2: Active Comparator |
Drug: Rebif
44ug administered with Rebiject II
|
3: Active Comparator |
Drug: Betaferon/Betaseron
250ug administrated with Betaject light
|
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any contraindication to the prescription of Betaferon® or Rebif®, as described in the SmPC of products:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 91489, EudraCT 2005-005583-91, 308084, Avantage |
Study First Received: | April 24, 2006 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00317941 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Multiple Sclerosis RRMS |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Interferons Interferon beta-1b Interferon beta 1a |
Interferon-beta Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Pathologic Processes Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic Pharmacologic Actions |