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Completed

NCT Number: NCT00317941

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

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.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aix-en-Provence, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Betaferon/Betaseron

Drug

250ug administrated with Betaject

Rebif

Drug

44ug administered with Rebiject II

Primary outcomes

  1. 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

    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

  2. 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

    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

  3. Mean Scores of Reaction After Injection Reported by Participants

    Time frame: Up to 3 months assessed every 24 and 48 hours after injection

    Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis

Secondary outcomes

  1. Percentage of Injection Sites With Pain Reported by Physicians

    Time frame: Up to 3 months

  2. Percentage of Injection Sites Per Participant With Reaction Reported by Physicians

    Time frame: Up to 3 months

  3. Percentage of Participants Without ISR Reported by Participants

    Time frame: Up to 3 months assessed every 24 hours after each injection

  4. Percentage of Sites Developing a Severe Reaction 24 Hours After Injection

    Time frame: Up to 3 months assessed every 24 hours after each 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

  5. Percentage of Sites Developing a Severe Reaction 48 Hours After Injection

    Time frame: Up to 3 months assessed every 48 hours after each 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

  6. Percentage of Participants Without Pain Reported by Participants

    Time frame: Up to 3 months assessed 24 hours after each injection

  7. Percentage of Injection Sites Without Pain Reported by Physicians

    Time frame: Up to 3 months

  8. Percentage of Injection Sites Without Pain Reported by Participants

    Time frame: Up to 3 months assessed 24 hours after each injection

  9. Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection

    Time frame: Immediately after injection

    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  10. Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection

    Time frame: 30 min after injection

    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  11. Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection

    Time frame: 1h after injection

    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  12. Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection

    Time frame: 24h after injection

    Visual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).

  13. 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

  14. 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

    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 outcomes

  1. Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors

    Time frame: Up to 3 months

    Score range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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®).

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 25, 2006
Registry last updated
Oct 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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