Clinical trial NCT00317941: Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif
Official title: 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®).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
RRMS
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-04-25
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Original French title of the study: Etude de phase IV, multicentrique, randomisée, ouverte, comparant les réactions et la douleur aux sites d'injection après administration sous-cutanée d'interféron β-1b (Betaferon®) ou interféron β-1a (Rebif®) pendant la période de trois mois d'initiation de la thérapie chez des patients atteints d'une forme récurrente/rémittente de sclérose en plaques.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection
timeFrame: Up to 3 months assessed every 24 hours after each injection
measure: Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection
timeFrame: Up to 3 months assessed every 48 hours after each injection
measure: Mean Scores of Reaction After Injection Reported by Participants
timeFrame: Up to 3 months assessed every 24 and 48 hours after injection
Secondary outcomes:
measure: Percentage of Injection Sites With Pain Reported by Physicians
timeFrame: Up to 3 months
measure: Percentage of Injection Sites Per Participant With Reaction Reported by Physicians
timeFrame: Up to 3 months
measure: Percentage of Participants Without ISR Reported by Participants
timeFrame: Up to 3 months assessed every 24 hours after each injection
measure: Percentage of Sites Developing a Severe Reaction 24 Hours After Injection
timeFrame: Up to 3 months assessed every 24 hours after each injection
measure: Percentage of Sites Developing a Severe Reaction 48 Hours After Injection
timeFrame: Up to 3 months assessed every 48 hours after each injection
measure: Percentage of Participants Without Pain Reported by Participants
timeFrame: Up to 3 months assessed 24 hours after each injection
measure: Percentage of Injection Sites Without Pain Reported by Physicians
timeFrame: Up to 3 months
measure: Percentage of Injection Sites Without Pain Reported by Participants
timeFrame: Up to 3 months assessed 24 hours after each injection
measure: Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection
timeFrame: Immediately after injection
measure: Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection
timeFrame: 30 min after injection
measure: Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection
timeFrame: 1h after injection
measure: Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection
timeFrame: 24h after injection
measure: Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants
timeFrame: Up to 3 months assessed every 24 hours after each injection
measure: Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants
timeFrame: Up to 3 months assessed every 48 hours after each injection
Other outcomes:
measure: Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors
timeFrame: Up to 3 months
Locations:
city: Aix en Provence
country: France
city: Alkirch
country: France
city: Annecy Cedex
country: France
city: Aurillac
country: France
city: Belfort
country: France
city: Blaye
country: France
city: Bordeaux
country: France
city: Boulogne sur Mer
country: France
city: Brest Cedex
country: France
city: Brive La Gaillarde
country: France
city: Carcassonne
country: France
city: Castelnau le Lez
country: France
city: ChamaliÃ¿res
country: France
city: Champigny sur Marne
country: France
city: Colmar
country: France
city: Corbeil Essones Cedex
country: France
city: CrÃ©teil
country: France
city: Dijon
country: France
city: Dreux
country: France
city: Dunkerque
country: France
city: Elbeuf
country: France
city: Evreux Cedex
country: France
city: Evry
country: France
city: La Seyne sur Mer
country: France
city: Le Mans Cedex
country: France
city: Le Mans
country: France
city: Libourne Cedex
country: France
city: Lille
country: France
city: Lomme Cedex
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montpellier Cedex 5
country: France
city: Montpellier
country: France
city: Nancy Cedex
country: France
city: Nancy
country: France
city: Nantes
country: France
city: Nice
country: France
city: Nimes Cedex 9
country: France
city: Paris
country: France
city: Pau
country: France
city: Perpignan
country: France
city: Poissy
country: France
city: Quimper Cedex
country: France
city: Quimper
country: France
city: Quimper
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Rueil Malmaison
country: France
city: Saint Herblain
country: France
city: Saint Quentin
country: France
city: St Etienne
country: France
city: St LÃ¿
country: France
city: St Omer
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
city: Trelaze
country: France
city: Vendome
country: France
city: Vesoul
country: France
city: Vichy
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: