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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01049451
First received: January 13, 2010
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as Acthar Gel® (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.


Condition Intervention Phase
Multiple Sclerosis
Drug: ACTH
Drug: Methylprednisolone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Annualized Relapse Rate [ Time Frame: 15 months study: 12 months treatment and 3 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 15 months: 12 months treatmen and 3 months follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: November 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACTH IM monthly
Subjects assigned to the ACTH arm will receive ACTH (Acthar gel) as intramuscular (IM) injections once a day for 3 consecutive days on a monthly basis, for 12 consecutive months. The dosage of ACTH will be 80 units per injection, for a total of 240 units over the three day period.
Drug: ACTH
Subjects assigned to the ACTH arm will receive ACTH (Acthar gel) as intramuscular (IM) injections once a day for 3 consecutive days on a monthly basis, for 12 consecutive months. The dosage of ACTH will be 80 units per injection, for a total of 240 units over the three day period.
Other Name: Acthar Gel
Active Comparator: MP IV monthly
Subjects assigned to the MP arm will receive intravenous (IV) infusions of 1 gram of MP once a month for 12 months.
Drug: Methylprednisolone
Subjects assigned to the MP arm will receive intravenous (IV) infusions of 1 gram of MP once a month for 12 months
Other Name: Solumedrol

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049451

Locations
United States, California
USC MS Comprehensive Care Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Regina R Berkovich, MD, PhD University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01049451     History of Changes
Other Study ID Numbers: Pulse ACTH vs. MP for MS, IND 104,973
Study First Received: January 13, 2010
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Southern California:
Multiple Sclerosis
ACTH
Steroids

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Adrenocorticotropic Hormone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Interferon-beta
Interferons
Interferon beta-1b
Methylprednisolone acetate
Prednisolone acetate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on August 21, 2014