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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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Interferon beta-1a (Avonex)

About this trial

This is an interventional basic science trial for Multiple Sclerosis focused on measuring Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Healthy Volunteers

MS patients previously naïve to interferon therapy

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00913666

First Posted

June 2, 2009

Last Updated

June 3, 2009

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00913666

Brief Title

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

Official Title

A Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX®, MS Subjects Naïve to Treatment, and Healthy Control Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple Sclerosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

No Intervention

Arm Description

Healthy Volunteers

Arm Title

Group 2

Arm Type

Experimental

Arm Description

MS patients previously naïve to interferon therapy

Arm Title

Group 3

Arm Type

Experimental

Arm Description

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

Arm Title

Group 4

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Interferon beta-1a (Avonex)

Other Intervention Name(s)

Avonex

Intervention Description

30 mcg by intramuscular injection once a week

Primary Outcome Measure Information:

Title

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

Time Frame

Study duration is 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Biogen-Idec Investigator

Organizational Affiliation

Biogen

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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