Trial Condition(s):
Relapsing-Remitting Multiple Sclerosis
Safety study in relapsing-remitting multiple sclerosis (RRMS) patients receiving Betaferon or Rebif
Bayer Identifier:
91489
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Males or females - Age >= 18 years old - Patients after a first demyelinating event suggestive of MS (only for Betaferon) as well as patients with a definite diagnosis of RRMS (Betaferon et Rebif) - First justified prescription of one interferon beta by subcutaneous route (as described in Summary of Product Characteristics [SmPC] of Betaferon or Rebif) - Females of child-bearing potential must agree to practice adequate contraceptive methods over the duration of the study (not applicable for men) - Patient can follow and comply with all study procedures of the trial protocol - Laboratory evaluations (i.e., evaluation of hepatic enzyme gamma-GT, full blood count and differential white blood cell count [WBC]) must be available and the results must be normal. - Written informed consent
Exclusion Criteria
- Any contraindication to the prescription of Betaferon or Rebif, as described in the SmPC of products: -- Pregnancy or lactation -- Known hypersensitivity to natural or recombinant interferon beta, to mannitol, to human albumin or any other excipients used -- History of severe depression or suicide attempt or current suicidal ideation. -- Patient with decompensated liver disease -- Epilepsy not adequately controlled by treatment - Patient previously included in this study. - Patient previously treated by sub-cutaneous route with either Betaferon or Rebif. - Participation in any clinical trial within the past 30 days involving the investigational drug intake. - Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Aix en Provence, France, 13616 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Belfort, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Blaye, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bordeaux, France, 33000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brest Cedex, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brive La Gaillarde, France, 19100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Carcassonne, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Champigny sur Marne, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Colmar, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Créteil, France, 94000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dijon, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dunkerque, France, 59140 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Evry, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Le Mans, France, 72000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lomme Cedex, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montpellier Cedex 5, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nancy, France, 54000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nancy Cedex, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nice, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paris, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Perpignan, France, 66000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quimper, France, 29000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quimper Cedex, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rennes, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alkirch, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Annecy Cedex, France, 74011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Aurillac, France, 15000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Boulogne sur Mer, France, 62321 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Castelnau le Lez, France, 34170 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chamaliÿres, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Corbeil Essones Cedex, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dreux, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Elbeuf, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Evreux Cedex, France, 27023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Seyne sur Mer, France, 83500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Le Mans Cedex, France | Status Completed | Contact Us: E-mail: [email protected]e.com Phone: Not Available |
Locations Investigative Site Libourne Cedex, France, 33505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lille, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lyon, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Marseille, France, 13006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montpellier, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nantes, France, 44000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nimes Cedex 9, France, 30900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pau, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Poissy, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quimper, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reims, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rouen, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rueil Malmaison, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saint Quentin, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Lÿ, France, 50000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Omer, France, 62505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toulouse, France, 31400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tourcoing, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vesoul, France, 70000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saint Herblain, France, 44800 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Etienne, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Strasbourg, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Trelaze, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vendome, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vichy, France | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
The AVANTAGE study - A randomized, multicenter, phase IV, open-label prospective study comparing injection site reaction and injection site pain in patients with relapsing remitting multiple sclerosis (RRMS) or after a first demyelinating event suggestive of MS newly started on interferon beta-1b (Betaferon®) or interferon beta-1a (Rebif®).
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Percentage of the sites developing a injection site reaction (ISR) reported by participants 24 hours after each injectionTimeframe: Up to 3 months assessed every 24 hours after each injection
- Percentage of sites developing a injection site reaction (ISR) reported by participants 48 hours after each injectionTimeframe: Up to 3 months assessed every 48 hours after each injection
- Mean scores of reaction after injection reported by participantsTimeframe: Up to 3 months assessed every 24 and 48 hours after injection
Secondary Outcome
- Percentage of injection sites with pain reported by physiciansTimeframe: Up to 3 months
- Percentage of injection sites per participant with reaction reported by physiciansTimeframe: Up to 3 months
- Percentage of participants without ISR reported by participantsTimeframe: Up to 3 months assessed every 24 hours after each injection
- Percentage of sites developing a severe reaction 24 hours after injectionTimeframe: Up to 3 months assessed every 24 hours after each injection
- Percentage of sites developing a severe reaction 48 hours after injectionTimeframe: Up to 3 months assessed every 48 hours after each injection
- Percentage of participants without pain reported by participantsTimeframe: Up to 3 months assessed 24 hours after each injection
- Percentage of injection sites without pain reported by physiciansTimeframe: Up to 3 months
- Percentage of injection sites without pain reported by participantsTimeframe: Up to 3 months assessed 24 hours after each injection
- Mean pain assessment using visual analogue scale (VAS) reported by participants immediately after injectionTimeframe: Immediately after injection
- Mean pain assessment using visual analogue scale (VAS) reported by participants 30 minutes after injectionTimeframe: 30 min after injection
- Mean pain assessment using visual analogue scale (VAS) reported by participants 1 hour after injectionTimeframe: 1h after injection
- Mean pain assessment using visual analogue scale (VAS) reported by participants 24 hours after injectionTimeframe: 24h after injection
- Percentage of sites without reaction 24 hours after injection reported by participantsTimeframe: Up to 3 months assessed every 24 hours after each injection
- Percentage of sites without reaction 48 hours after injection reported by participantsTimeframe: Up to 3 months assessed every 48 hours after each injection
Additional Information
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