check_circleStudy Completed

relapsing-remitting multiple sclerosis

Safety study in relapsing-remitting multiple sclerosis (RRMS) patients receiving Betaferon or Rebif

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.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - 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
  • - 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
220
Trial Dates
March 2006 - April 2008
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Aix en Provence, 13616, France
Completed
Belfort, France
Completed
Blaye, France
Completed
Bordeaux, 33000, France
Completed
Brest Cedex, France
Completed
Brive La Gaillarde, 19100, France
Completed
Carcassonne, France
Completed
Champigny sur Marne, France
Completed
Colmar, France
Completed
Créteil, 94000, France
Completed
Dijon, France
Completed
Dunkerque, 59140, France
Completed
Evry, France
Completed
Le Mans, 72000, France
Completed
Lomme Cedex, France
Completed
Montpellier Cedex 5, France
Completed
Nancy, 54000, France
Completed
Nancy Cedex, France
Completed
Nice, France
Completed
Paris, France
Completed
Perpignan, 66000, France
Completed
Quimper, 29000, France
Completed
Quimper Cedex, France
Completed
Rennes, France
Completed
Alkirch, France
Completed
Annecy Cedex, 74011, France
Completed
Aurillac, 15000, France
Completed
Boulogne sur Mer, 62321, France
Completed
Castelnau le Lez, 34170, France
Completed
Chamaliÿres, France
Completed
Corbeil Essones Cedex, France
Completed
Dreux, France
Completed
Elbeuf, France
Completed
Evreux Cedex, 27023, France
Completed
La Seyne sur Mer, 83500, France
Completed
Le Mans Cedex, France
Completed
Libourne Cedex, 33505, France
Completed
Lille, France
Completed
Lyon, France
Completed
Marseille, 13006, France
Completed
Montpellier, France
Completed
Nantes, 44000, France
Completed
Nimes Cedex 9, 30900, France
Completed
Pau, France
Completed
Poissy, France
Completed
Quimper, France
Completed
Reims, France
Completed
Rouen, France
Completed
Rueil Malmaison, France
Completed
Saint Quentin, France
Completed
St Lÿ, 50000, France
Completed
St Omer, 62505, France
Completed
Toulouse, 31400, France
Completed
Tourcoing, France
Completed
Vesoul, 70000, France
Completed
Saint Herblain, 44800, France
Completed
St Etienne, France
Completed
Strasbourg, France
Completed
Trelaze, France
Completed
Vendome, France
Completed
Vichy, France

Primary Outcome

  • Percentage of the sites developing a injection site reaction (ISR) reported by participants 24 hours after each injection
    date_rangeTime Frame:
    Up to 3 months assessed every 24 hours after each injection
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of sites developing a injection site reaction (ISR) reported by participants 48 hours after each injection
    date_rangeTime Frame:
    Up to 3 months assessed every 48 hours after each injection
    enhanced_encryption
    Safety Issue:
    Yes
  • Mean scores of reaction after injection reported by participants
    date_rangeTime Frame:
    Up to 3 months assessed every 24 and 48 hours after injection
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Percentage of injection sites with pain reported by physicians
    date_rangeTime Frame:
    Up to 3 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of injection sites per participant with reaction reported by physicians
    date_rangeTime Frame:
    Up to 3 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of participants without ISR reported by participants
    date_rangeTime Frame:
    Up to 3 months assessed every 24 hours after each injection
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of sites developing a severe reaction 24 hours after injection
    date_rangeTime Frame:
    Up to 3 months assessed every 24 hours after each injection
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of sites developing a severe reaction 48 hours after injection
    date_rangeTime Frame:
    Up to 3 months assessed every 48 hours after each injection
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of participants without pain reported by participants
    date_rangeTime Frame:
    Up to 3 months assessed 24 hours after each injection
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of injection sites without pain reported by physicians
    date_rangeTime Frame:
    Up to 3 months
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of injection sites without pain reported by participants
    date_rangeTime Frame:
    Up to 3 months assessed 24 hours after each injection
    enhanced_encryption
    Safety Issue:
    No
  • Mean pain assessment using visual analogue scale (VAS) reported by participants immediately after injection
    date_rangeTime Frame:
    Immediately after injection
    enhanced_encryption
    Safety Issue:
    No
  • Mean pain assessment using visual analogue scale (VAS) reported by participants 30 minutes after injection
    date_rangeTime Frame:
    30 min after injection
    enhanced_encryption
    Safety Issue:
    No
  • Mean pain assessment using visual analogue scale (VAS) reported by participants 1 hour after injection
    date_rangeTime Frame:
    1h after injection
    enhanced_encryption
    Safety Issue:
    No
  • Mean pain assessment using visual analogue scale (VAS) reported by participants 24 hours after injection
    date_rangeTime Frame:
    24h after injection
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of sites without reaction 24 hours after injection reported by participants
    date_rangeTime Frame:
    Up to 3 months assessed every 24 hours after each injection
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of sites without reaction 48 hours after injection reported by participants
    date_rangeTime Frame:
    Up to 3 months assessed every 48 hours after each injection
    enhanced_encryption
    Safety Issue:
    Yes

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