Multiple Sclerosis, Relapsing-RemittingNCT02633033
Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Mallinckrodt at 38 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- How many people
- 160 participants
- Where
- 38 sitesUnited States
- Study dates
- 24 Nov 2015to 9 May 2019
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a relapsing form of MS who initiate treatment with Acthar Gel for an MS exacerbation
Who may be able to join
- Male or Female ≥ 18 years of age.
- Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).
- Patient with an acute MS exacerbation as determined by their treating clinician.
- Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.
- Patient capable of providing informed consent.
Who cannot join
- Patients with a diagnosis of Progressive MS.
- Patients that require concomitant corticosteroid therapy.
- Patients receiving experimental drug therapy.
- Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years.
- 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.
- 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.
- If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Optimum Neurology
Bala-Cynwyd, Pennsylvania, 19004
University System of Maryland
Baltimore, Maryland, 21201
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
Columbus Research & Wellness Institute
Columbus, Georgia, 31904
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, 06824
Detroit Clinical Research Center
Farmington Hills, Michigan, 48334
Advanced Neurosciences Research
Fort Collins, Colorado, 80528
Neurology Center of New England
Foxborough, Massachusetts, 02035
CentraState Medical Center
Freehold, New Jersey, 07728
Alabama Neurology Associates
Homewood, Alabama, 35209
Milford Regional Medical Center
Hopedale, Massachusetts, 01747
Irene Greenhouse MD
Jamison, Pennsylvania, 18929
Emery Neuroscience Center
Lighthouse PT, Florida, 33064
Neurology and Stroke Associates
Lititz, Pennsylvania, 17543
International Neurorehabilitation Institute
Lutherville, Maryland, 21093
Neurology of Central Georgia
Macon, Georgia, 31210
Neurology Associates
Maitland, Florida, 32751
Cordova Research Institute
Miami, Florida, 33155
Braunstein Neurology
Mooresville, North Carolina, 28117
Collier Neurologic Specialists
Naples, Florida, 34102
Strotira, Inc.
New York, New York, 11714
Florida Neurological Center
Ocala, Florida, 34471
Ogden Clinic
Ogden, Utah, 84403
Neurological Services of Orlando
Orlando, Florida, 32806
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174
College Park Family Care Center
Overland Park, Kansas, 66212
Dominion Neurological Services
Richmond, Virginia, 23226
Negroski, Sutherland and Hanes Neurology
Sarasota, Florida, 34239
Meridian Clinical Research
Savannah, Georgia, 31406
Alpha Neurology
Staten Island, New York, 10306
Colonial Healthcare
Sumter, South Carolina, 29150
Infinity Clinical Research
Sunrise, Florida, 33351
The Toledo Clinic
Toledo, Ohio, 43623
Territory Neurology & Research Institute
Tucson, Arizona, 85704
Oak Clinic for Multiple Sclerosis
Uniontown, Ohio, 44685
MedStar Health
Washington D.C., District of Columbia, 20007
D. Gary Kolva, MD, Neurology
West Reading, Pennsylvania, 19610
Five Towns Neurology
Woodmere, New York, 11598
About this study
Official title: A Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis Relapse
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.
Read the detailed 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Acthar, Corticotropin, MS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 2 months
Secondary outcomes (18)
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
Measured: within 6 months
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
Measured: within 6 months
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
Measured: within 6 months
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
Measured: within 6 months
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
Measured: within 6 months
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).
Measured: within 6 months
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
Measured: within 6 months
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
Measured: within 6 months
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
Measured: within 6 months
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
Measured: within 6 months
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
Measured: within 6 months
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).
Measured: within 6 months
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).
Measured: within 6 months
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).
Measured: within 6 months
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).
Measured: within 6 months
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).
Measured: within 6 months
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).
Measured: within 6 months
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).
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start24 Nov 2015
- Primary completion9 May 2019
- Study completion9 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mallinckrodt ARD Inc.
- Responsible party
- Sponsor
- Investigators
- Study Directo, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633033
- Sponsor's protocol ID
- MNK14130050
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2015
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kaplan J, Miller T, Baker M, Due B, Zhao E. Repository corticotropin injection improves quality metrics in an observational study of multiple sclerosis relapse. Neurodegener Dis Manag. 2021 Dec;11(6):469-476. doi: 10.2217/nmt-2021-0030. Epub 2021 Dec 3.
PubMed 34860120Kaplan J, Miller T, Baker M, Due B, Zhao E. A Prospective Observational Registry of Repository Corticotropin Injection (Acthar(R) Gel) for the Treatment of Multiple Sclerosis Relapse. Front Neurol. 2020 Dec 22;11:598496. doi: 10.3389/fneur.2020.598496. eCollection 2020.
PubMed 33414758
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Registry of H.P. Acthar® Gel for the Treatment of Multiple Sclerosis Relapse
- ClinicalTrials.gov ID
- NCT02633033
- Acronym / sponsor ID
- MNK14130050
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Multiple Sclerosis, Relapsing-Remitting, Acthar, Corticotropin, MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Collaborators
- Mallinckrodt ARD Inc.
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a relapsing form of MS who initiate treatment with Acthar Gel for an MS exacerbation
Key inclusion criteria (5 listed)
- Male or Female ≥ 18 years of age.
- Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).
- Patient with an acute MS exacerbation as determined by their treating clinician.
- Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.
- Patient capable of providing informed consent.
Key exclusion criteria (7 listed)
- Patients with a diagnosis of Progressive MS.
- Patients that require concomitant corticosteroid therapy.
- Patients receiving experimental drug therapy.
- Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical subscale score of the Multiple Sclerosis Impact Scale, v.1 (MSIS-29v1)
Time frame: at 2 months
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).
18 secondary outcomes
Physical subscale score of the MSIS-29v1 within 6 months
Time frame: within 6 months
Psychological 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
Clinical Global Impression of Improvement Scale (CGI-I)
Time frame: within 6 months
Total score of the MSIS-29v1 within 6 months
Time frame: within 6 months
Number of participants with treatment response based on the MSIS-29v1 physical subscale score
Time frame: within 6 months
Number of participants with treatment response based on the EDSS
Time frame: within 6 months
Percent of normal work hours missed (absenteeism) due to MS exacerbation
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 participants with overall Impairment at Work (absenteeism + presenteeism) due to MS exacerbation
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 days per month an unpaid caregiver missed work due to the patient's MS
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 MS-related emergency department visits
Time frame: within 6 months
Number of MS-related hospitalizations
Time frame: within 6 months
Number of MS-related MRIs
Time frame: within 6 months
Number of days per month of MS-related paid and unpaid caregiver assistance
Time frame: within 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Derived from this study: PubMed 34860120Kaplan J, Miller T, Baker M, Due B, Zhao E. Repository corticotropin injection improves quality metrics in an observational study of multiple sclerosis relapse. Neurodegener Dis Manag. 2021 Dec;11(6):469-476. doi: 10.2217/nmt-2021-0030. Epub 2021 Dec 3.
- Derived from this study: PubMed 33414758Kaplan J, Miller T, Baker M, Due B, Zhao E. A Prospective Observational Registry of Repository Corticotropin Injection (Acthar(R) Gel) for the Treatment of Multiple Sclerosis Relapse. Front Neurol. 2020 Dec 22;11:598496. doi: 10.3389/fneur.2020.598496. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Directo study director
Mallinckrodt
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Mallinckrodt at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical subscale score of the Multiple Sclerosis Impact Scale, v.1 (MSIS-29v1) (time frame: at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02633033, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.