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Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis

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

Condition(s) targeted: Multiple Sclerosis

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

Phase: Phase 3

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 determine if the study drug is effective and safe in the treatment of Multiple Sclerosis (MS) in patients of Chinese origin.

Clinical Details

Official title: Open Label Study to Evaluate the Effect, Safety and Tolerability of 250µg (8 MIU) Interferon Beta 1b (Betaferon) Given Subcutaneously Every Other Day (for 24 Weeks) in Patients of Chinese Origin With Multiple Sclerosis

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Difference Between the Number of Newly Active Lesions in Magnetic Resonance Imaging (MRI) Per Three Months During the 6-month Treatment Period and the Number of Newly Active Lesions During 3-month Pre-treatment

Secondary outcome:

Difference Between the Number of New Gadolinium (Gd)-Enhancing Lesions Per 3 Months During the 6-month Treatment Period and the Number of New Gd-enhancing Lesions During 3-month Pre-treatment

Difference Between the Number of New or Enlarging T2 Lesions Per 3 Months During the 6-month Treatment Period and the Number of New or Enlarging T2 Lesions During 3-month Pre-treatment

Detailed description: 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: 16 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Chinese origin

- diagnosis of Relapsing remitting multiple sclerosis or secondary progressive

multiple sclerosis Exclusion Criteria:

- Any disease other than Multiple Sclerosis (MS) that could better explain the patients

signs and symptoms

- HIV (human immunodeficiency virus) infections

- Hepatitis A

- Syphilis

- immunodeficiency

- rheumatic disease or Sjogren syndrome

- heart disease

- severe depression

- pregnancy or lactation

- conditions interfering with Magnetic Resonance Imaging (MRI)

- Gadolinium DTPA (Gadovist, contrast agent) allergy

- allergy against human proteins, paracetamol, acetaminophen and ibuprofen intolerance

- participation in other trial

Locations and Contacts

Beijing 100050, China

Beijing 100730, China

Shanghai 200040, China

Additional Information

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Starting date: November 2006
Last updated: May 26, 2013

Page last updated: August 20, 2015

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