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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01119677
First received: May 6, 2010
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

This is a randomized, 3-arm, dose-blinded, parallel-group study. Subjects will be randomized to one of 3 treatment titration regimes (slow titration over 6 weeks, fast titration over 3 weeks, and no titration).


Condition Intervention
Healthy
Drug: Avonex

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomized, Three-Arm, Dose-Blinded, Parallel-Group Study to Determine the Effect of Avonex® Dose Titration on the Severity and Incidence of Interferon Beta-1a-Related Flu Like Symptoms in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To determine whether titration of Avonex reduces the incidence of flu like symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the overall safety and tolerability of Avonex IM injections [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
No dose titration
Drug: Avonex
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 2
Fast dose titration
Drug: Avonex
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 3
Slow dose titration
Drug: Avonex
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy Volunteers

Criteria

Inclusion Criteria:

  • Must be healthy males or females aged 18 to 55 years old at the time of informed consent.
  • Must have a Body Mass Index of 19 to 30 kg/m2, and a minimum body weight of 50.0 kg at Screening.
  • Female subjects 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.

Exclusion Criteria:

  • 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 subjects 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119677

Locations
United States, Minnesota
Research Site
St. Paul, Minnesota, United States
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided by Biogen Idec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen Idec, Sponsor
ClinicalTrials.gov Identifier: NCT01119677     History of Changes
Other Study ID Numbers: 108HV103
Study First Received: May 6, 2010
Last Updated: April 14, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Interferon beta 1a
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014