Clinical 15 Months Study Comparing Monthly Pulse ACTH (Acthar Gel) Therapy With Monthly Methylprednisolone (MP, Solumedrol) for Multiple Sclerosis (MS) Patients Who Are on Regular Beta-interferons (Avonex, Betaseron or Rebif)
Information source: University of Southern California
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: ACTH (Drug); Methylprednisolone (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: University of Southern California Official(s) and/or principal investigator(s):
Regina R Berkovich, MD, PhD, Principal Investigator, Affiliation: University of Southern California
Summary
We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as
Acthar GelŪ (MANUFACTURER NAME) is effective in the control of clinical disease activity as
a pulse therapy for relapsing-remitting MS when added to standard treatment with
beta-interferon.
We wish to determine whether ACTH, when administered as clustered monthly intramuscular
injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and
effective alternative to monthly pulse therapy with MP. In addition, we hypothesize that
pulse therapy with ACTH alters immune function to favor a regulatory, rather than a
pro-inflammatory T cell environment.
Clinical Details
Official title: Comparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Annualized Relapse Rate
Secondary outcome: Multiple Sclerosis Functional Composite (MSFC), Expanded Disability Status Scale score (EDSS) and Multiple Sclerosis Quality of Life (MSQOL), peripheral blood lymphocytes measure for regulatory immune activities.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Clinically definite multiple sclerosis defined by McDonald Criteria.
2. Between 18-65 years of age.
3. Subject must able to understand and sign the IRB- approved informed consent form
prior to the performance of any study-specific procedures and is willing to comply
with the required scheduling and assessments of the protocol, including
self-administration of study drug (if assigned to the ACTH arm).
4. Subjects who are women of childbearing potential, must have a negative serum
pregnancy test at the screening visit, and must be willing to practice a reliable
birth-control method.
5. Subjects must have at least one MS relapse within last year and/or at least one new
T2 or Gadolinium-enhanced lesion on MRI while on stable interferon therapy.
6. EDSS (Expanded Disability Status Scale) score of 3. 0 - 6. 5
7. Currently on one of the approved beta-interferon drugs (Avonex, Betaseron, or Rebif)
for a minimum of 6 months.
Exclusion Criteria:
1. Women who are either pregnant or breastfeeding, and women of child-bearing potential
(defined as not surgically sterile or at least two years post menopausal) who are not
using one of the following birth control methods: tubal ligation, implantable
contraception device, oral, patch, injectable or transdermal contraceptive, barrier
method or sexual activity restricted to vasectomized partner.
2. Uncontrolled hypertension, clinically significant cardiac arrhythmias,
gastrointestinal ulcer, uncontrolled diabetes mellitus, osteoporosis, any stage of
renal failure, psychiatric disorders or any other clinically significant general
health conditions that may interfere with the trial participation.
3. Subject has a history of drug or alcohol abuse within the past year.
4. Subject had corticosteroid treatment within last 90 days.
5. Subject started new medication within last 30 days.
6. Subject is on Tysabri treatment presently or within 6 months of screening.
7. Subject is on Novantrone, Cellcept, Rituxan or other chemotherapeutic treatment
presently or within 6 months of screening.
8. Subject is a participant in another research project.
9. Subject has contraindications for either ACTH or MP administration.
Locations and Contacts
USC MS Comprehensive Care Center, Los Angeles, California 90033, United States
Additional Information
Starting date: November 2009
Last updated: April 2, 2013
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