Clinical trial NCT01119677: A Study of Avonex to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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.

Key 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 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: To determine whether titration of Avonex reduces the incidence of flu like symptoms
timeFrame: 8 weeks
Secondary outcomes:
measure: To evaluate the overall safety and tolerability of Avonex IM injections
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Research Site
state: Minnesota
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.