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Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Interferon beta-1a (Avonex) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Biogen-Idec Investigator, Principal Investigator, Affiliation: Biogen

Summary

This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a.

Clinical Details

Official title: A Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX«, MS Subjects Na´ve to Treatment, and Healthy Control Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Changes in bioanalytical measures after receiving therapy for 3 to 6 months

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Healthy Control Subjects (Group 1)

- Must be in general good health.

- Must not have received interferons in the past.

All MS Subjects

- Clinical or laboratory-supported diagnosis of relapsing remitting MS (McDonald et al,

criteria numbers 1-4).

- Either on AVONEX® or treatment-naïve.

- Have an EDSS score between 0. 0 and 5. 5, inclusive.

Exclusion Criteria:

- History of severe allergic or anaphylactic reaction or hypersensitivity to human

albumin, to any interferon, to other components of the drug formulation.

- History of intolerance to acetaminophen, ibuprofen, naproxen, and aspirin that would

preclude the use of at least one of these during the study.

- 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.

- History of malignancy.

- The presence of any significant medical condition or psychiatric illness not due to

MS that, in the investigator's opinion, would interfere with therapy

- History of uncontrolled seizures within the 3 months prior to enrollment.

- History of suicidal ideation or an episode of severe depression within the 3 months

prior to enrollment.

- Serious local infection (e. g., cellulitis, abscess) or systemic infection (e. g.,

pneumonia, septicemia) within 8 weeks prior to enrollment.

- Positive for human immunodeficiency virus (HIV), hepatitis C antibody (HCV) or

positive for hepatitis B surface antigen (HbsAg) at screening. Other inclusion and exclusion criteria apply as per protocol

Locations and Contacts

Additional Information

Starting date: November 2002
Last updated: June 3, 2009

Page last updated: August 20, 2015

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