Pharmacodynamic Study to Better Understand the Therapeutic Response an
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
What it found
We found no results in the registry or in papers.
This trial finished 22 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
Changes in bioanalytical measures after receiving therapy for 3 to 6 months
Study duration is 6 months
Who could take part
Relapsing MS · 18 to 65 · EDSS 0.0 to 5.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a.
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History
Started
Nov 2002
Finished
Nov 2004