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BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study

Bayer logo

Bayer

Status and phase

Completed
Phase 3

Conditions

Multiple Sclerosis

Treatments

Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00185211
305207 (Other Identifier)
91031

Details and patient eligibility

About

This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).

Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare Pharmaceuticals Inc..

Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.

Enrollment

468 patients

Sex

All

Ages

18 to 48 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who have reached scheduled end of study in BENEFIT, either by developing CDMS or by completing 24 months

Exclusion criteria

  • No participation in the initial BENEFIT study

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

468 participants in 2 patient groups

Initial IFNB-1b (Interferon beta-1b)
Experimental group
Description:
Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
Treatment:
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Initial Placebo
Experimental group
Description:
Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
Treatment:
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Trial contacts and locations

94

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Data sourced from clinicaltrials.gov

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