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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-remitting Multiple Sclerosis

Intervention: Betaferon/Betaseron (Drug); Rebif (Drug); Betaferon/Betaseron (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250”g or Rebif 44”g using different autoinjectors.

Clinical Details

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 (Betaferonź) or Interferon Beta-1a (Rebifź).

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

Primary outcome:

Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection

Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection

Mean Scores of Reaction After Injection Reported by Participants

Secondary outcome:

Percentage of Injection Sites With Pain Reported by Physicians

Percentage of Injection Sites Per Participant With Reaction Reported by Physicians

Percentage of Participants Without ISR Reported by Participants

Percentage of Sites Developing a Severe Reaction 24 Hours After Injection

Percentage of Sites Developing a Severe Reaction 48 Hours After Injection

Percentage of Participants Without Pain Reported by Participants

Percentage of Injection Sites Without Pain Reported by Physicians

Percentage of Injection Sites Without Pain Reported by Participants

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

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

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

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

Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants

Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants

Detailed description: Original French title of the study: Etude de phase IV, multicentrique, randomisĂ©e, ouverte, comparant les rĂ©actions et la douleur aux sites d'injection aprĂšs administration sous-cutanĂ©e d'interfĂ©ron ÎČ-1b (BetaferonÂź) ou interfĂ©ron ÎČ-1a (RebifÂź) pendant la pĂ©riode de trois mois d'initiation de la thĂ©rapie chez des patients atteints d'une forme rĂ©currente/rĂ©mittente de sclĂ©rose 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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Aix en Provence 13616, France

Alkirch, France

Annecy Cedex 74011, France

Aurillac 15000, France

Belfort, France

Blaye, France

Bordeaux 33000, France

Boulogne sur Mer 62321, France

Brest Cedex, France

Brive La Gaillarde 19100, France

Carcassonne, France

Castelnau le Lez 34170, France

Chamaliÿres, France

Champigny sur Marne, France

Colmar, France

Corbeil Essones Cedex, France

Créteil 94000, France

Dijon, France

Dreux, France

Dunkerque 59140, France

Elbeuf, France

Evreux Cedex 27023, France

Evry, France

La Seyne sur Mer 83500, France

Le Mans Cedex, France

Le Mans 72000, France

Libourne Cedex 33505, France

Lille, France

Lomme Cedex, France

Lyon, France

Marseille 13006, France

Montpellier Cedex 5, France

Montpellier, France

Nancy Cedex, France

Nancy 54000, France

Nantes 44000, France

Nice, France

Nimes Cedex 9 30900, France

Paris, France

Pau, France

Perpignan 66000, France

Poissy, France

Quimper Cedex, France

Quimper 29000, France

Quimper, France

Reims, France

Rennes, France

Rouen, France

Rueil Malmaison, France

Saint Herblain 44800, France

Saint Quentin, France

St Etienne, France

St Lÿ 50000, France

St Omer 62505, France

Strasbourg, France

Toulouse 31400, France

Tourcoing, France

Trelaze, France

Vendome, France

Vesoul 70000, France

Vichy, France

Additional Information

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.

Starting date: March 2006
Last updated: August 15, 2013

Page last updated: August 20, 2015

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