Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif

Relapsing-remitting Multiple Sclerosis Clinical Trial

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®).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317941
• Other study ID #: 91489
• Secondary ID: 2005-005583-9130
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2006
• Last updated: August 15, 2013
• Start date: March 2006
• Est. completion date: April 2008

Study information

• Verified date: August 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Betaferon/Betaseron
250ug administrated with Betaject
• Rebif
44ug administered with Rebiject II
• Betaferon/Betaseron
250ug administrated with Betaject light

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors	Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis	Up to 3 months	No
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Percentage of Injection Sites With Pain Reported by Physicians		Up to 3 months	Yes
Secondary	Percentage of Injection Sites Per Participant With Reaction Reported by Physicians		Up to 3 months	Yes
Secondary	Percentage of Participants Without ISR Reported by Participants		Up to 3 months assessed every 24 hours after each injection	Yes
Secondary	Percentage of Sites Developing a Severe Reaction 24 Hours After Injection	An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis	Up to 3 months assessed every 24 hours after each injection	Yes
Secondary	Percentage of Sites Developing a Severe Reaction 48 Hours After Injection	An ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis	Up to 3 months assessed every 48 hours after each injection	Yes
Secondary	Percentage of Participants Without Pain Reported by Participants		Up to 3 months assessed 24 hours after each injection	No
Secondary	Percentage of Injection Sites Without Pain Reported by Physicians		Up to 3 months	No
Secondary	Percentage of Injection Sites Without Pain Reported by Participants		Up to 3 months assessed 24 hours after each injection	No
Secondary	Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection	Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).	Immediately after injection	No
Secondary	Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection	Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).	30 min after injection	No
Secondary	Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection	Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).	1h after injection	No
Secondary	Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection	Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).	24h after injection	No
Secondary	Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants		Up to 3 months assessed every 24 hours after each injection	Yes
Secondary	Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants	if the patient score is missing, at the injection site, then the patient is not considered without or with developping reaction.; An injection site is seen as developing no reaction if the patient's score for this site is of a reaction intensity = 0.	Up to 3 months assessed every 48 hours after each injection	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.