Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif
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®).
4 other identifiers
interventional
220
1 country
59
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2006
Typical duration for phase_4
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 24, 2006
CompletedFirst Posted
Study publicly available on registry
April 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
October 21, 2013
CompletedOctober 21, 2013
August 1, 2013
2.1 years
April 24, 2006
May 24, 2013
August 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection
An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed
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 Injection
An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed
Up to 3 months assessed every 48 hours after each injection
Mean Scores of Reaction After Injection Reported by Participants
Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis
Up to 3 months assessed every 24 and 48 hours after injection
Secondary Outcomes (14)
Percentage of Injection Sites With Pain Reported by Physicians
Up to 3 months
Percentage of Injection Sites Per Participant With Reaction Reported by Physicians
Up to 3 months
Percentage of Participants Without ISR Reported by Participants
Up to 3 months assessed every 24 hours after each injection
Percentage of Sites Developing a Severe Reaction 24 Hours After Injection
Up to 3 months assessed every 24 hours after each injection
Percentage of Sites Developing a Severe Reaction 48 Hours After Injection
Up to 3 months assessed every 48 hours after each injection
- +9 more secondary outcomes
Other Outcomes (1)
Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors
Up to 3 months
Study Arms (3)
IFNB-1b 250 mcg (Betaseron) via Betaject
EXPERIMENTALInterferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
IFNB-1b 250 mcg (Betaseron) via Betaject light
EXPERIMENTALInterferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
IFNB-1a 44 mcg (Rebif) via Rebiject II
ACTIVE COMPARATORInterferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (59)
Unknown Facility
Aix-en-Provence, 13616, France
Unknown Facility
Alkirch, France
Unknown Facility
Annecy, 74011, France
Unknown Facility
Aurillac, 15000, France
Unknown Facility
Belfort, France
Unknown Facility
Blaye, France
Unknown Facility
Bordeaux, 33000, France
Unknown Facility
Boulogne-sur-Mer, 62321, France
Unknown Facility
Brest, France
Unknown Facility
Brive-la-Gaillarde, 19100, France
Unknown Facility
Carcassonne, France
Unknown Facility
Castelnau-le-Lez, 34170, France
Unknown Facility
Chamaliÿres, France
Unknown Facility
Champigny-sur-Marne, France
Unknown Facility
Colmar, France
Unknown Facility
Corbeil Essones Cedex, France
Unknown Facility
Créteil, 94000, France
Unknown Facility
Dijon, France
Unknown Facility
Dreux, France
Unknown Facility
Dunkirk, 59140, France
Unknown Facility
Elbeuf, France
Unknown Facility
Évreux, 27023, France
Unknown Facility
Évry, France
Unknown Facility
La Seyne-sur-Mer, 83500, France
Unknown Facility
Le Mans, 72000, France
Unknown Facility
Le Mans, France
Unknown Facility
Libourne, 33505, France
Unknown Facility
Lille, France
Unknown Facility
Lomme, France
Unknown Facility
Lyon, France
Unknown Facility
Marseille, 13006, France
Unknown Facility
Montpellier, France
Unknown Facility
Nancy, 54000, France
Unknown Facility
Nancy, France
Unknown Facility
Nantes, 44000, France
Unknown Facility
Nice, France
Unknown Facility
Nîmes, 30900, France
Unknown Facility
Paris, France
Unknown Facility
Pau, France
Unknown Facility
Perpignan, 66000, France
Unknown Facility
Poissy, France
Unknown Facility
Quimper, 29000, France
Unknown Facility
Quimper, France
Unknown Facility
Reims, France
Unknown Facility
Rennes, France
Unknown Facility
Rouen, France
Unknown Facility
Rueil-Malmaison, France
Unknown Facility
Saint Lÿ, 50000, France
Unknown Facility
Saint-Etienne, France
Unknown Facility
Saint-Herblain, 44800, France
Unknown Facility
Saint-Omer, 62505, France
Unknown Facility
Saint-Quentin, France
Unknown Facility
Strasbourg, France
Unknown Facility
Toulouse, 31400, France
Unknown Facility
Tourcoing, France
Unknown Facility
Trélazé, France
Unknown Facility
Vendôme, France
Unknown Facility
Vesoul, 70000, France
Unknown Facility
Vichy, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 24, 2006
First Posted
April 25, 2006
Study Start
March 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
October 21, 2013
Results First Posted
October 21, 2013
Record last verified: 2013-08