NCT00913250

Brief Summary

Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1 multiple-sclerosis

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_1 multiple-sclerosis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
Last Updated

June 4, 2009

Status Verified

June 1, 2009

First QC Date

June 2, 2009

Last Update Submit

June 3, 2009

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisInterferon beta-1a

Outcome Measures

Primary Outcomes (1)

  • To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers.

    Study duration is 72 days

Study Arms (2)

Sequence 1

EXPERIMENTAL

Serum containing Avonex followed by serum free Avonex

Drug: Serum containing Avonex

Sequence 2

EXPERIMENTAL

Serum free Avonex followed by serum containing Avonex

Drug: Serum Free Avonex

Interventions

Serum containing AvonexDRUG

60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15

Also known as: Avonex
Sequence 1
Serum Free AvonexDRUG

60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15.

Also known as: Avonex
Sequence 2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Volunteers

You may not qualify if:

  • History of severe allergic or anaphylactic reactions
  • History of hypersensitivity to acetaminophen (paracetamol), ibuprofen, or codeine.
  • Known allergy to dry natural rubber
  • History of seizure disorder or unexplained blackouts
  • History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Biogen-Idec Investigator

    Biogen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 4, 2009

Study Start

August 1, 2003

Study Completion

October 1, 2003

Last Updated

June 4, 2009

Record last verified: 2009-06