Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

A Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633033
• Other study ID #: MNK14130050
• Status: Completed
• Start date: November 24, 2015
• Est. completion date: May 9, 2019

Study information

• Verified date: December 2019
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Acthar Gel was first approved by the Food and Drug Administration in 1952.

It has been used to treat many different illnesses, including multiple sclerosis.

This study will observe how treatment with Acthar affected the daily lives of patients who suffer with relapsing/remitting MS.

It will collect information on symptoms, recovery, treatment patterns and safety outcomes.

Description:

Acthar Gel (repository corticotropin injection) contains a non-bovine analogue of adrenocorticotropic hormone (ACTH) for intramuscular or subcutaneous use.

It was initially approved by the FDA in 1952 and is used for multiple indications.

This registry will evaluate the use of Acthar Gel for the treatment of MS exacerbations in the United States.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 9, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
United States	Optimum Neurology	Bala-Cynwyd	Pennsylvania
United States	University System of Maryland	Baltimore	Maryland
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	Columbus Research & Wellness Institute	Columbus	Georgia
United States	Associated Neurologists of Southern Connecticut	Fairfield	Connecticut
United States	Detroit Clinical Research Center	Farmington Hills	Michigan
United States	Advanced Neurosciences Research	Fort Collins	Colorado
United States	Neurology Center of New England	Foxboro	Massachusetts
United States	CentraState Medical Center	Freehold	New Jersey
United States	Alabama Neurology Associates	Homewood	Alabama
United States	Milford Regional Medical Center	Hopedale	Massachusetts
United States	Irene Greenhouse MD	Jamison	Pennsylvania
United States	Emery Neuroscience Center	Lighthouse Point	Florida
United States	Neurology and Stroke Associates	Lititz	Pennsylvania
United States	International Neurorehabilitation Institute	Lutherville	Maryland
United States	Neurology of Central Georgia	Macon	Georgia
United States	Neurology Associates	Maitland	Florida
United States	Cordova Research Institute	Miami	Florida
United States	Braunstein Neurology	Mooresville	North Carolina
United States	Collier Neurologic Specialists	Naples	Florida
United States	Strotira, Inc.	New York	New York
United States	Florida Neurological Center	Ocala	Florida
United States	Ogden Clinic	Ogden	Utah
United States	Neurological Services of Orlando	Orlando	Florida
United States	Neurology Associates of Ormond Beach	Ormond Beach	Florida
United States	College Park Family Care Center	Overland Park	Kansas
United States	Dominion Neurological Services	Richmond	Virginia
United States	Negroski, Sutherland and Hanes Neurology	Sarasota	Florida
United States	Meridian Clinical Research	Savannah	Georgia
United States	Alpha Neurology	Staten Island	New York
United States	Colonial Healthcare	Sumter	South Carolina
United States	Infinity Clinical Research	Sunrise	Florida
United States	The Toledo Clinic	Toledo	Ohio
United States	Territory Neurology & Research Institute	Tucson	Arizona
United States	Oak Clinic for Multiple Sclerosis	Uniontown	Ohio
United States	MedStar Health	Washington	District of Columbia
United States	D. Gary Kolva, MD, Neurology	West Reading	Pennsylvania
United States	Five Towns Neurology	Woodmere	New York

Sponsors (2)

Lead Sponsor	Collaborator
Mallinckrodt	Mallinckrodt ARD Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical subscale score of the Multiple Sclerosis Impact Scale, v.1 (MSIS-29v1)	Participants rate 20 physical symptoms of multiple sclerosis (MS) on a scale from 1=not at all to 5=extremely. The highest possible score is 100. Higher scores mean physical symptoms of MS have a higher impact on day-to-day life.; For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	at 2 months
Secondary	Physical subscale score of the MSIS-29v1 within 6 months	Participants rate 20 physical symptoms of MS on a scale from 1=not at all to 5=extremely. The highest possible score is 100. Higher scores mean physical symptoms of MS have a higher impact on day-to-day life.; For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).; Rows: at 2 weeks, at 1 Month, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Secondary	Psychological subscale score of the MSIS-29v1 within 6 months	Participants rate 9 psychological symptoms of MS on a scale from 1=not at all to 5=extremely. The highest possible score is 45. Higher scores mean psychological symptoms of MS have a higher impact on day-to-day life.; For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).; Rows: at 2 weeks, at 1 Month, at 2 months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Secondary	Score on the Expanded Disability Status Scale/Functional System Score (EDSS/FSS)	Treating clinicians trained in completing the EDSS/FSS (neurologist or other healthcare professional such as a nurse practitioner or physician assistant) complete the EDSS/FSS to evaluate patient neurologic impairment.; The EDSS is based on the standard neurological examination and is used by the clinician in conjunction with the Functional System Score (FSS) to produce a disability score. The FSS is a companion scale that is part of the EDSS; Expanded Disability Status Scale (EDSS) is a well validated 10 point ordinal clinical rating scale with scores ranging from 0 (normal neurological examination) to 10 (death due to MS) in 0.5 point increments. The highest possible score is 100. A higher score means more neurological disability.; For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).; Rows: at Baseline, at 2 Months, at 6 Months	within 6 months
Secondary	Clinical Global Impression of Improvement Scale (CGI-I)	Treating clinicians complete the CGI-I. It is a scale that compares the overall condition of the patient to baseline. Scores range from 1 (very much improved) to 7 (very much worse). The highest possible score is 7. Lower scores mean improvement.; For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).; Rows: at Baseline, at 2 Months, at 6 Months	within 6 months
Secondary	Total score of the MSIS-29v1 within 6 months	Participants rate 29 psychological symptoms of MS on a scale from 1=not at all to 5=extremely. The highest possible score is 145. Higher scores mean total symptoms of MS have a higher impact on day-to-day life.; For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).; Rows: at 2 weeks, at 1 Month, at 2 months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Secondary	Number of participants with treatment response based on the MSIS-29v1 physical subscale score	Treatment response is defined as an 8-point improvement on the MSIS-29v1 physical subscale score at 2 weeks and 1, 2, 3, 4, 5 and 6 months.; For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Secondary	Number of participants with treatment response based on the EDSS	Treatment response is defined as a 0.5 point improvement on the EDSS at 2 and 6 months.; For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).; Rows: at 2 Months, at 6 Months	within 6 months
Secondary	Percent of normal work hours missed (absenteeism) due to MS exacerbation	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).; Rows: at 2 weeks, at 1 Month, at 2 Months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Secondary	Number of participants with impairment at work and/or reduced on-the-job effectiveness (presenteeism) due to MS exacerbation	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).; Rows: at 1 Week, at 2 Weeks, at 3 Weeks, at 4 Weeks, at 6 Weeks, at 2 Months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Secondary	Number of participants with overall Impairment at Work (absenteeism + presenteeism) due to MS exacerbation	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).; Rows: at 1 Week, at 2 Weeks, at 3 Weeks, at 4 Weeks, at 6 Weeks, at 2 Months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Secondary	Number of participants with Impairment in activities other than work due to MS exacerbation	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).; Rows: at 1 Week, at 2 Weeks, at 3 Weeks, at 4 Weeks, at 6 Weeks, at 2 Months, at 3 Months, at 4 Months, at 5 Months, at 6 Months	within 6 months
Secondary	Number of days per month an unpaid caregiver missed work due to the patient's MS	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Secondary	Number of MS-related off-site clinical/office visits with a specialist or a general practitioner	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Secondary	Number of MS-related healthcare professional visits at home	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Secondary	Number of MS-related emergency department visits	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Secondary	Number of MS-related hospitalizations	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Secondary	Number of MS-related MRIs	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months
Secondary	Number of days per month of MS-related paid and unpaid caregiver assistance	For patients having a relapse during the study period, the schedule of assessments restarts at the time of relapse(s).	within 6 months