Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02633033
• Date of registration: 15/12/2015
• Prospective Registration: No
• Primary sponsor: Mallinckrodt
• Public title: Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse
• Scientific title: A Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis Relapse
• Date of first enrolment: November 24, 2015
• Target sample size: 160
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02633033
• Study type: Observational [Patient Registry]

Countries of recruitment

Puerto Rico, United States

Contacts

• Name: Study Directo
• Affiliation: Mallinckrodt

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Primary Outcome(s)

Physical subscale score of the Multiple Sclerosis Impact Scale, v.1 (MSIS-29v1) [Time Frame: at 2 months]

Secondary Outcome(s)

Number of days per month an unpaid caregiver missed work due to the patient's MS [Time Frame: within 6 months]

Number of participants with treatment response based on the EDSS [Time Frame: within 6 months]

Number of participants with Impairment in activities other than work due to MS exacerbation [Time Frame: within 6 months]

Number of participants with treatment response based on the MSIS-29v1 physical subscale score [Time Frame: within 6 months]

Psychological subscale score of the MSIS-29v1 within 6 months [Time Frame: within 6 months]

Total score of the MSIS-29v1 within 6 months [Time Frame: within 6 months]

Clinical Global Impression of Improvement Scale (CGI-I) [Time Frame: within 6 months]

Number of MS-related emergency department visits [Time Frame: within 6 months]

Number of MS-related hospitalizations [Time Frame: within 6 months]

Number of MS-related off-site clinical/office visits with a specialist or a general practitioner [Time Frame: within 6 months]

Number of MS-related healthcare professional visits at home [Time Frame: within 6 months]

Number of participants with impairment at work and/or reduced on-the-job effectiveness (presenteeism) due to MS exacerbation [Time Frame: within 6 months]

Number of days per month of MS-related paid and unpaid caregiver assistance [Time Frame: within 6 months]

Number of MS-related MRIs [Time Frame: within 6 months]

Number of participants with overall Impairment at Work (absenteeism + presenteeism) due to MS exacerbation [Time Frame: within 6 months]

Physical subscale score of the MSIS-29v1 within 6 months [Time Frame: within 6 months]

Score on the Expanded Disability Status Scale/Functional System Score (EDSS/FSS) [Time Frame: within 6 months]

Percent of normal work hours missed (absenteeism) due to MS exacerbation [Time Frame: within 6 months]

Secondary ID(s)

MNK14130050

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mallinckrodt ARD Inc.