Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis

Bayer

Status and phase

Completed

Phase 2

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00235989

91272

307320 (Other Identifier)

Beyond

Details and patient eligibility

About

The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

Full description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

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

Enrollment

63 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed and dated statement of informed consent
Completion of Protocol 307000A
Negative serum pregnancy test results
Agreement to adequate contraception, for female patients

Exclusion criteria

Pregnancy or lactation
History of alcohol or drug abuse
Inability to administer subcutaneous injections either by self or by caregiver
Medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study
Any significant change in the patient's medical condition after enrollment in Study 307000A which would have lead to his/her exclusion from participation that study

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 4 patient groups

ET: IFNB-1b 250 mcg => 250 mcg

Active Comparator group

Description:

Extension Treatment 250 mcg continued

Treatment:

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

ET: IFNB-1b 500 mcg => 250 mcg

Experimental group

Description:

Extension Treatment 500 mcg reduced to 250 mcg

Treatment:

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

ET: IFNB-1b 500 mcg => 500 mcg

Experimental group

Description:

Extension Treatment 500 mcg continued

Treatment:

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

ET: IFNB-1b 250 mcg => 500 mcg

Experimental group

Description:

Extension Treatment 250 mcg increased to 500 mcg

Treatment:

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

Trial contacts and locations

17

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