How Side Effects of Avonex Are Affected by Gradually Incr... | NCT00574041

Studies
How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose

NCT00574041

Sponsor

Biogen

Status

Terminated

Last Update Posted

Sep 4, 2008Estimated

Enrollment

19Actual

Phase

Phase 4

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

Interferon beta-1a

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated due to poor recruitment

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Dec 12, 2007

First Submission Date that Met QC Criteria

Dec 13, 2007

First Posted Date

Dec 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2008

Last Update Posted Date

Sep 4, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to find out if starting at low dose Avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of Avonex treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	titrated dose of Avonex	Drug: Interferon beta-1a
2	Active Comparator	full dose Avonex	Drug: Interferon beta-1a

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interferon beta-1a	Drug	injected, once a week	1 2	Avonex

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the mean severity of episodes of FLS during the 4 week titration phase		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
To assess the mean severity and duration of FLS episodes in post-titration phase		throughout study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of clinically-definite relapsing-remitting multiple sclerosis

Exclusion Criteria:

Any Product Information-specified contraindications to interferon-beta therapy, or other medical factors which, in the opinion of the investigator, make the subject unsuitable for interferon-beta therapy
Use of AVONEX, but not other interferon therapies, in the 3 months prior to randomisation into the study
A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomisation.
History of seizure in the 3 months prior to randomisation
History of suicidal ideation or severe depression within the 3 months prior to randomisation.
Other inclusion and exclusion criteria may apply per study protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Biogen-Idec Investigator	Biogen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Coordinating Research Site		Malvern	Victoria	3144	Australia

Condition Browse Module

MeSH Terms

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068556	Interferon beta-1a

Ancestor Terms

ID	Term
D016899	Interferon-beta
D007370	Interferon Type I
D007372	Interferons
D016207	Cytokines

Browse Leaves

Not provided

Browse Branches

Not provided