A Study of Avonex to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers

NCT01119677 | Completed Phase 1

• 1 other identifier: 108HV103
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to determine whether titration of Avonex reduces the severity of flu-like symptoms (FLS). Secondary objectives of this study are to determine whether titration of Avonex reduces the incidence of FLS and to evaluate the overall safety and tolerability of Avonex intramuscular (IM) injections.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• To determine whether titration of Avonex reduces the incidence of flu like symptoms

  8 weeks

Secondary Outcomes (1)

• To evaluate the overall safety and tolerability of Avonex IM injections

  8 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

No dose titration

Drug: Avonex

Group 2

EXPERIMENTAL

Fast dose titration

Drug: Avonex

Group 3

EXPERIMENTAL

Slow dose titration

Drug: Avonex

Interventions

Avonex DRUG

Group 1 subjects will receive weekly Avonex 30 mcg (full dose) IM injections from Week 1 to Week 8. Group 2 subjects will titrate in quarter dose increments every week up to a full dose of Avonex over a 3 week period from Week 1 to Week 3 and then continue on full dose from Week 4 to Week 8. Group 3 subjects will titrate in quarter dose increments every 2 weeks up to a full dose of Avonex over a 6 week period from Week 1 to Week 6 and continue on full dose from Week 7 to Week 8

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must have a Body Mass Index of 19 to 30 kg/m2, and a minimum body weight of 50.0 kg at Screening.
• Female participants of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

You may not qualify if:

• Known history of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus (test for hepatitis C virus antibody \[HCV Ab\]) or hepatitis B virus (test for hepatitis B surface antigen \[HBsAg\] and hepatitis B core antibody \[HBcAb\])
• Known history of chronic fatigue syndrome or fibromyalgia
• Within one month, flu-like illnesses (e.g., gastroenteritis, upper respiratory infection, common cold)
• History of severe allergic reactions to any drug or anaphylactic reactions
• Known allergy to Avonex or any of its components
• Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to Screening or active bacterial or viral infection
• History of alcohol or substance abuse (as defined by the Investigator)
• Female participants who are pregnant or currently breastfeeding
• Any previous treatment with any interferon product.10. Vaccinations within 2 weeks or 5 half-lives, whichever is longer, prior to Day 1
• Blood donation within 30 days prior to Screening
• Use of any tobacco product more than 5 times within 30 days prior to Screening

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Saint Paul, Minnesota, United States

Location

Related Publications (1)

• Matson MA, Zimmerman TR Jr, Tuccillo D, Tang Y, Deykin A. Dose titration of intramuscular interferon beta-1a reduces the severity and incidence of flu-like symptoms during treatment initiation. Curr Med Res Opin. 2011 Dec;27(12):2271-8. doi: 10.1185/03007995.2011.630720. Epub 2011 Oct 28.

  PMID: 21988668 DERIVED

MeSH Terms

Interventions

Interferon beta-1a

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

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 7, 2010
• Study Start: May 5, 2010
• Primary Completion: October 23, 2010
• Study Completion: October 23, 2010
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

US (1)