Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)

Study Overview
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Brief Summary
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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
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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 manifesting both focally in the form of lesions and diffusely in otherwise normal-appearing brain tissue. Recent data shows that ACTH can have beneficial effects on specific neurodegenerative diseases and it may have superior neuroprotective effects. Adding a regimen of ACTH to standard Avonex treatment may provide neuroprotection and promote remyelination.

Official Title
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Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: repository corticotropin injection
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adrenocorticotropin hormone<br>Patients receive the hormone | Drug: repository corticotropin injection<br>* IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months<br>* Other names: H.P. Acthar gel;|
| Placebo Comparator: Placebo<br>Patients receive placebo only | Drug: Saline<br>* I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS | Effect of ACTH in MRI | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. in RRMS on anterior optic pathway pathology, as measured by OCT and LCLA in patients with RRMS. | Effect of ACTH on optic health | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, relapsing remitting, RRMS