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Observational Registry of H.P. Acthar® Gel for Multiple Sclerosis Relapse

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ClinicalTrials.gov Identifier: NCT02633033
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
This observational study aims to characterize the patient population and describe multiple sclerosis exacerbation recovery, treatment patterns and safety outcomes in patients with multiple sclerosis experiencing exacerbations treated with H.P. Acthar® Gel (Acthar Gel) in standard practice in the United States.

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting Drug: H.P. Acthar® Gel (repository corticotropin injection)

Detailed Description:
H.P. Acthar Gel (repository corticotropin injection) contains a porcine analogue of adrenocorticotropic hormone (ACTH) for intramuscular or subcutaneous use. H.P. Acthar Gel (Acthar Gel) was initially approved by the FDA in 1952 and has multiple indications of use. This registry will evaluate the use of Acthar Gel for the treatment of exacerbations of multiple sclerosis (MS) in the US.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: A Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis Relapse
Actual Study Start Date : November 24, 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: H.P. Acthar® Gel (repository corticotropin injection)
    Other Name: Acthar


Primary Outcome Measures :
  1. Multiple Sclerosis Impact Scale version 1 (MSIS-29v1) [ Time Frame: 6 months post exacerbation ]
    Evaluates the physical and psychological impact of MS


Secondary Outcome Measures :
  1. MS exacerbation recovery [ Time Frame: 6 months ]
    Describe MS exacerbation recovery (e.g., neurologic functional) and treatment response over a period of 6 months following index exacerbation and any relapses.

  2. MS exacerbation recovery [ Time Frame: 6 months ]
    Describe MS exacerbation recovery (e.g., symptom improvement) and treatment response over a period of 6 months following index exacerbation and any relapses.

  3. MS exacerbation recovery [ Time Frame: 6 months ]
    Describe MS exacerbation recovery (e.g., productivity loss) and treatment response over a period of 6 months following index exacerbation and any relapses.

  4. MS treatment patterns [ Time Frame: 42 months ]
    Describe MS treatment patterns (e.g., Acthar Gel, disease modifying therapy [DMT]) from index exacerbation to the end of the study period.

  5. MS relapse characteristics [ Time Frame: 42 months ]
    Describe relapse characteristics (e.g., symptoms) for patients who experience relapses following the index exacerbation during the study period.

  6. MS relapse characteristics [ Time Frame: 42 months ]
    Describe relapse characteristics (e.g., time to relapse) for patients who experience relapses following the index exacerbation during the study period.

  7. MS relapse characteristics [ Time Frame: 42 months ]
    Describe relapse characteristics (e.g., severity of relapse) for patients who experience relapses following the index exacerbation during the study period.

  8. MS relapse characteristics [ Time Frame: 42 months ]
    Describe relapse characteristics (e.g., relapse treatment) for patients who experience relapses following the index exacerbation during the study period.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with a relapsing form of MS who initiate treatment with Acthar Gel for an MS exacerbation
Criteria

Inclusion Criteria:

  1. Male or Female ≥ 18 years of age.
  2. Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).
  3. Patient with an acute MS exacerbation as determined by their treating clinician.
  4. Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.
  5. Patient capable of providing informed consent.

Exclusion Criteria:

  1. Patients with a diagnosis of Progressive MS.
  2. Patients that require concomitant corticosteroid therapy.
  3. Patients receiving experimental drug therapy.
  4. Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years.
  5. Patient has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to the Enrollment Visit, with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix.
  6. Patients who had recent surgery or have a history of or the presence of a peptic ulcer within 6 months prior to study entry, congestive heart failure, or sensitivity to proteins of porcine origin.
  7. If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633033


Contacts
Contact: Sean Ma 800-556-3314 clinicaltrials@mnk.com
Contact: Bryan Due 800-556-3314 clinicaltrials@mnk.com

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Sponsors and Collaborators
Mallinckrodt
Investigators
Study Director: Bryan Due, PhD Mallinckrodt

Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02633033     History of Changes
Other Study ID Numbers: MNK14130050
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Keywords provided by Mallinckrodt:
Multiple Sclerosis
Relapsing-Remitting
Acthar
Corticotropin
MS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs