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

Biogen

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00913666

C-863

Details and patient eligibility

About

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

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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121 participants in 4 patient groups

Group 1

No Intervention group

Description:

Healthy Volunteers

Group 2

Experimental group

Description:

MS patients previously naïve to interferon therapy

Treatment:

Drug: Interferon beta-1a (Avonex)

Group 3

Experimental group

Description:

MS patients on Interferon beta-1a treatment with no history of breakthrough disease (clinically stable)

Treatment:

Drug: Interferon beta-1a (Avonex)

Group 4

Experimental group

Description:

MS patients on interferon beta-1a treatment with a history of breakthrough disease.

Treatment:

Drug: Interferon beta-1a (Avonex)