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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00317941
First received: April 24, 2006
Last updated: August 15, 2013
Last verified: August 2013
  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.


Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis
Drug: Betaferon/Betaseron
Drug: Rebif
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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®).

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection [ Time Frame: Up to 3 months assessed every 24 hours after each injection ] [ Designated as safety issue: Yes ]
    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

  • Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection [ Time Frame: Up to 3 months assessed every 48 hours after each injection ] [ Designated as safety issue: Yes ]
    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

  • Mean Scores of Reaction After Injection Reported by Participants [ Time Frame: Up to 3 months assessed every 24 and 48 hours after injection ] [ Designated as safety issue: Yes ]
    Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis


Secondary Outcome Measures:
  • Percentage of Injection Sites With Pain Reported by Physicians [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
  • Percentage of Injection Sites Per Participant With Reaction Reported by Physicians [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Without ISR Reported by Participants [ Time Frame: Up to 3 months assessed every 24 hours after each injection ] [ Designated as safety issue: Yes ]
  • Percentage of Sites Developing a Severe Reaction 24 Hours After Injection [ Time Frame: Up to 3 months assessed every 24 hours after each injection ] [ Designated as safety issue: Yes ]
    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

  • Percentage of Sites Developing a Severe Reaction 48 Hours After Injection [ Time Frame: Up to 3 months assessed every 48 hours after each injection ] [ Designated as safety issue: Yes ]
    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

  • Percentage of Participants Without Pain Reported by Participants [ Time Frame: Up to 3 months assessed 24 hours after each injection ] [ Designated as safety issue: No ]
  • Percentage of Injection Sites Without Pain Reported by Physicians [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Percentage of Injection Sites Without Pain Reported by Participants [ Time Frame: Up to 3 months assessed 24 hours after each injection ] [ Designated as safety issue: No ]
  • Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection [ Time Frame: Immediately after injection ] [ Designated as safety issue: No ]
    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  • Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection [ Time Frame: 30 min after injection ] [ Designated as safety issue: No ]
    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  • Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection [ Time Frame: 1h after injection ] [ Designated as safety issue: No ]
    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  • Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection [ Time Frame: 24h after injection ] [ Designated as safety issue: No ]
    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  • Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants [ Time Frame: Up to 3 months assessed every 24 hours after each injection ] [ Designated as safety issue: Yes ]
  • Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants [ Time Frame: Up to 3 months assessed every 48 hours after each injection ] [ Designated as safety issue: Yes ]

    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.



Other Outcome Measures:
  • Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis


Enrollment: 220
Study Start Date: March 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IFNB-1b 250 mcg (Betaseron) via Betaject
Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
Drug: Betaferon/Betaseron
250ug administrated with Betaject
Experimental: IFNB-1b 250 mcg (Betaseron) via Betaject light
Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
Drug: Betaferon/Betaseron
250ug administrated with Betaject light
Active Comparator: IFNB-1a 44 mcg (Rebif) via Rebiject II
Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
Drug: Rebif
44ug administered with Rebiject II

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317941

  Show 61 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00317941     History of Changes
Other Study ID Numbers: 91489, 2005-005583-91, 308084, Avantage
Study First Received: April 24, 2006
Results First Received: May 24, 2013
Last Updated: August 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Bayer:
Multiple Sclerosis
RRMS

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Interferon-beta
Interferons
Interferon beta-1b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on August 28, 2014