Physical Disability in Patients Treated With Betaferon - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00873340

Purpose

The purpose of this study is

To gather Observational data about physical disability progression, safety and adherence during the use of Betaferon in daily practice.
Patients with any type of Multiple Sclerosis (MS) (MRRS) (PSMS), under treatment with Betaferon.
Open Multicentric Observational study.
24 months.
Evaluation of physical disability in patients treated with Betaferon, using Kurtzke's expanded disability scale (EDSS) in biannual periods

Condition	Intervention
Multiple Sclerosis	Drug: Interferon-1beta (Betaseron BAY86-5046)

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta-1b Interferons

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice

Further study details as provided by Bayer:

Primary Outcome Measures:

To collect observational local data about effectivity related to physical disability progression on the daily routine basis in patients treated with Betaferon [ Time Frame: Every 6 months for 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate Betaferon safety on the daily routine basis [ Time Frame: Every 6 months ] [ Designated as safety issue: Yes ]
To evaluate patient adherence to Betaferon treatment [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Interferon-1beta (Betaseron BAY86-5046) Patients with a first demyelinating event suggestive of MS, as well as patients with remittent recurrent MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS) will be observed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

MS community sample

Criteria

Inclusion Criteria:

Patients with a first demyelinating event suggestive of MS, as well as patients with remittent recurrent MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS) will be able to join the study.

Exclusion Criteria:

Pregnancy
Patients with a history of hypersensitivity to natural or recombinant interferon-beta, human albumin or to any of the excipients
Patients with a history of severe depressive disorders and/or suicidal ideation
Patient with decompensated liver disease
Patient with epilepsy not adequately controlled by treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873340

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Colombia
	Recruiting
Many Locations, Colombia

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Medical Director )
Study ID Numbers:	14173, BF0712CO
Study First Received:	March 31, 2009
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00873340 History of Changes
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; United States: Food and Drug Administration

Keywords provided by Bayer:

MS
Multiple Sclerosis
Betaferon
Colombia

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Immunologic Factors
Demyelinating Diseases
Interferons
Adjuvants, Immunologic

Interferon-beta
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Nervous System Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic

Sclerosis
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009