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

NCT00574041 | Terminated Phase 4

• 1 other identifier: AUS-8002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; Avonex; side effects; flu like symptoms

Outcome Measures

Primary Outcomes (1)

• To assess the mean severity of episodes of FLS during the 4 week titration phase

  4 weeks

Secondary Outcomes (1)

• To assess the mean severity and duration of FLS episodes in post-titration phase

  throughout study

Study Arms (2)

1

EXPERIMENTAL

titrated dose of Avonex

Drug: Interferon beta-1a

2

ACTIVE COMPARATOR

full dose Avonex

Drug: Interferon beta-1a

Interventions

Interferon beta-1a DRUG

injected, once a week

Also known as: Avonex

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of clinically-definite relapsing-remitting multiple sclerosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Coordinating Research Site

Malvern, Victoria, 3144, Australia

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Biogen-Idec Investigator

  Biogen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: June 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 4, 2008

Record last verified: 2008-09

Locations

AU (1)