Status:
WITHDRAWN
Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)
Lead Sponsor:
University at Buffalo
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is effective in the treatment of relapsing remitting multiple sclerosis.
Detailed Description
Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system (CNS). It is a complex, multi-factorial disease that includes inflammatory and neurodegenerative processes m...
Eligibility Criteria
Inclusion
- Patient diagnosed with MS according to McDonald criteria
- Age 18-65
- Have a RR disease course
- Have EDSS scores 0-5.5
- Have a disease duration \<20 years
- Sub-optimal response to Interferon beta-1a I.M. (Avonex®) while being on therapy for at least 6 months defined as:
- presence of a documented relapse within the last 12 months
- or the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months
- Signed informed consent
- Normal kidney functioning (creatinine clearance \>59)
- None of the exclusion criteria
Exclusion
- Presence of relapse or steroid treatment within 60 days prior to study enrollment
- Presence of neutralizing antibodies to IFNβ-1a I.M. prior to study enrollment
- Presence of optic neuritis within less than 6 months prior to study enrollment
- Diagnosis of osteoporosis (T score ≥2.5 SD)
- Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
- Abnormal blood tests, performed during the screening visit including: hepatitis B or hepatitis C, ALT or AST greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes
- History of depression while on IFNβ-1a I.M.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00986960
Start Date
December 1 2009
End Date
December 1 2010
Last Update
January 5 2021
Active Locations (1)
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1
University at Buffalo, Buffalo General Hospital
Buffalo, New York, United States, 14203