Multiple SclerosisNCT01906684
Comprehensive Analysis of Relapse in Multiple Sclerosis
A study testing Acthar Gel in people with Multiple Sclerosis, run by Tanner Foundation for Multiple Sclerosis at 1 site in United States.
Trial summary
This study will determine changes in: 1) the immune activity, characterized as the "immunorepertoire;" 2) 7 Tesla MRI brain images; 3) clinical outcomes; and 4) patient reported quality of life outcomes in subjects with relapsing-remitting multiple sclerosis who are treated with Acthar Gel. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Acthar Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jan 2015
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible to participate in the study if:
- They were diagnosed with Relapsing-Remitting Multiple Sclerosis within 1 year of their participation in the study Are established patients of the Tanner Center for MS Seek care for relapse within 72 hours of onset Are between the ages of 19 and 65 inclusively.
- Relapse will be confirmed and defined as the acute worsening of function that lasts for at least 24 hours with any of the manifestations of Central Nervous System relapses (excluding spinal cord) including:
- Brain stem syndrome Optic neuritis Cerebellar syndromes Hemi-motor/sensory events Males and Females are both eligible Patients of any race or ethnicity are eligible Are not pregnant (as confirmed by pregnancy test at the time of enrollment) or nursing Have no known contraindicating conditions (see exclusions)
Who cannot join
- Potential participants will be excluded if they do not meet the above criteria, and also if:
- They are currently being treated for MS with the any of the following disease-modifying drugs: Tysabri, Gilenya, Aubagio, Tecfidera They have a history of experiencing significant adverse reactions to corticosteroids They are deemed by Dr Riser to be better served with an intervention other than Acthar Gel to treat their current MS relapse Are pregnant or nursing
- Are known to have any of the contraindicating conditions:
- Scleroderm Osteoporosis Systemic fungal infections Ocular herpes simplex Recent surgery History of or presence of peptic ulcer Congestive heart failure Uncontrolled hypertension Adreno-cortical insufficiency, hyper-function or sensitivity Sensitivity to proteins of porcine origin
Trial locations and contacts
1 site in 1 country.
United States1 site
Tanner Center for MS
Birmingham, Alabama, 35209
Emily S Riser, MD
About this study
This study will determine changes in: 1) the immune activity, characterized as the "immunorepertoire;" 2) 7 Tesla MRI brain images; 3) clinical outcomes; and 4) patient reported quality of life outcomes in subjects with relapsing-remitting multiple sclerosis who are treated with Acthar Gel.
Read the detailed description
20 patients with documented Multiple Sclerosis, who have been diagnosed within 12 months of enrollment in the study and who are currently experiencing an MS relapse, defined as the following manifestation:
Acute onset or worsening of any of the manifestations of CNS relapses (excluding spinal cord) including:
- Brain stem syndrome
- Optic neuritis
- Cerebellar syndromes
If they choose to participate, subjects will be asked to:
Meet at the Clinic 4 times:
- Initial visit
- 5 days after baseline visit
- 14 days after baseline visit
- 30 days after baseline visit
Meet with neurologist for neurological exam that will include a:
- Review of neurological status
- Review of new and ongoing symptoms
- Review of symptom resolution
- Review of any side effects or adverse events
- Resolution of any patient questions and concerns
- Provide a 40cc whole blood sample
At each of the 4 visits
- Consent to Acthar Gel treatment for their relapse for 14 days (or as required for their relapse)
- Ss will agree to be trained in self-administration of Acthar
- First dose administered at Baseline visit
- Self-administered days 2-14 of participation
- Complete 4 psychometric instruments
At baseline and 30 day visit
- Cognitive assessment using the Brief International Cognitive Assessment for MS (Benedict 2012)
- Administered by Tanner Center Staff specially trained in this assessment
- Quality of Life assessments: self-administered
- MSQoL (Cella et al, 1006)
- Psychological Adjustment to Illness Survey (Rodrigue et al 2000)
- Coping Skills Inventory (Liveneh, 2003)
- Participate in a brief semi-structured interview, at Day 5 visit
- Conditions
- Multiple Sclerosis
- Being tested
- Acthar Gel
- Keywords
- Acthar Gel, MS relapse, 7T MRI imaging, Quality of Life
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar GelDrug
Patients who present with MS relapse within 72 hours of onset will be recruited for study. Upon consent they will be administered Achtar Gel for 5-14 days as clinically appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Acthar Gel | Experimental | Acthar Gel is supplied as 5 mL multi-dose vial (63004-8710-1) containing 80 USP Units per mL. H.P. Acthar Gel (repository corticotropin injection). Acthar Gel will be administered as a subcutaneous daily dose of 80 units for up to 2 weeks. Receives: Drug: Acthar Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in immunorepertoire, MRI imaging, clinical outcomes and patient reported quality of life
This study will observe changes in the activity of b cells and t cells as evidenced in the patient's immunorepertoire, as well as changes in 7T MRI images, physician-documented clinical outcomes in patients receiving Acthar Gel for treatment of MS relapse at four time points: baseline, 5, 14 and 30 days post initiation of treatment.
Measured: within 1 month post initiation of treatment with Acthar Gel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanner Foundation for Multiple Sclerosis
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt, Auburn University, iReportoire Inc
- Responsible party
- Sponsor
- Investigators
- Emily S Riser, MD, Principal investigator, Tanner Center for MS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906684
- Sponsor's protocol ID
- TFMS:QP1-2013
- Status last verified
- Jul 2013
- First submitted
- 19 Jul 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Analysis of Relapse in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01906684
- Acronym / sponsor ID
- TFMS:QP1-2013
- Conditions
- Multiple Sclerosis
- Keywords
- Acthar Gel, MS relapse, 7T MRI imaging, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tanner Foundation for Multiple SclerosisUniversity, hospital or other
- Collaborators
- Mallinckrodt, Auburn University, iReportoire Inc
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 24 Jul 2013 (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.
This study will determine changes in: 1) the immune activity, characterized as the "immunorepertoire;" 2) 7 Tesla MRI brain images; 3) clinical outcomes; and 4) patient reported quality of life outcomes in subjects with relapsing-remitting multiple sclerosis who are treated with Acthar Gel.
Detailed description
20 patients with documented Multiple Sclerosis, who have been diagnosed within 12 months of enrollment in the study and who are currently experiencing an MS relapse, defined as the following manifestation:
Acute onset or worsening of any of the manifestations of CNS relapses (excluding spinal cord) including:
- Brain stem syndrome
- Optic neuritis
- Cerebellar syndromes
If they choose to participate, subjects will be asked to:
Meet at the Clinic 4 times:
- Initial visit
- 5 days after baseline visit
- 14 days after baseline visit
- 30 days after baseline visit
Meet with neurologist for neurological exam that will include a:
- Review of neurological status
- Review of new and ongoing symptoms
- Review of symptom resolution
- Review of any side effects or adverse events
- Resolution of any patient questions and concerns
- Provide a 40cc whole blood sample
At each of the 4 visits
- Consent to Acthar Gel treatment for their relapse for 14 days (or as required for their relapse)
- Ss will agree to be trained in self-administration of Acthar
- First dose administered at Baseline visit
- Self-administered days 2-14 of participation
- Complete 4 psychometric instruments
At baseline and 30 day visit
- Cognitive assessment using the Brief International Cognitive Assessment for MS (Benedict 2012)
- Administered by Tanner Center Staff specially trained in this assessment
- Quality of Life assessments: self-administered
- MSQoL (Cella et al, 1006)
- Psychological Adjustment to Illness Survey (Rodrigue et al 2000)
- Coping Skills Inventory (Liveneh, 2003)
- Participate in a brief semi-structured interview, at Day 5 visit
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acthar Gel | Experimental | Drug: Acthar GelActhar Gel is supplied as 5 mL multi-dose vial (63004-8710-1) containing 80 USP Units per mL. H.P. Acthar Gel (repository corticotropin injection). Acthar Gel will be administered as a subcutaneous daily dose of 80 units for up to 2 weeks. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients will be eligible to participate in the study if:
- They were diagnosed with Relapsing-Remitting Multiple Sclerosis within 1 year of their participation in the study Are established patients of the Tanner Center for MS Seek care for relapse within 72 hours of onset Are between the ages of 19 and 65 inclusively.
- Relapse will be confirmed and defined as the acute worsening of function that lasts for at least 24 hours with any of the manifestations of Central Nervous System relapses (excluding spinal cord) including:
- Brain stem syndrome Optic neuritis Cerebellar syndromes Hemi-motor/sensory events Males and Females are both eligible Patients of any race or ethnicity are eligible Are not pregnant (as confirmed by pregnancy test at the time of enrollment) or nursing Have no known contraindicating conditions (see exclusions)
Key exclusion criteria (4 listed)
- Potential participants will be excluded if they do not meet the above criteria, and also if:
- They are currently being treated for MS with the any of the following disease-modifying drugs: Tysabri, Gilenya, Aubagio, Tecfidera They have a history of experiencing significant adverse reactions to corticosteroids They are deemed by Dr Riser to be better served with an intervention other than Acthar Gel to treat their current MS relapse Are pregnant or nursing
- Scleroderm Osteoporosis Systemic fungal infections Ocular herpes simplex Recent surgery History of or presence of peptic ulcer Congestive heart failure Uncontrolled hypertension Adreno-cortical insufficiency, hyper-function or sensitivity Sensitivity to proteins of porcine origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acthar GelPatients who present with MS relapse within 72 hours of onset will be recruited for study. Upon consent they will be administered Achtar Gel for 5-14 days as clinically appropriate. | Drug | Acthar Gel |
Primary outcome
Changes in immunorepertoire, MRI imaging, clinical outcomes and patient reported quality of life
Time frame: within 1 month post initiation of treatment with Acthar Gel
This study will observe changes in the activity of b cells and t cells as evidenced in the patient's immunorepertoire, as well as changes in 7T MRI images, physician-documented clinical outcomes in patients receiving Acthar Gel for treatment of MS relapse at four time points: baseline, 5, 14 and 30 days post initiation of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
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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.
Emily S Riser, MD principal investigator
Tanner Center for MS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acthar Gel in people with Multiple Sclerosis, run by Tanner Foundation for Multiple Sclerosis at 1 site 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ritalinda D Lee, PhD (256-714-0683, rlee@tannerms.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in immunorepertoire, MRI imaging, clinical outcomes and patient reported quality of life (time frame: within 1 month post initiation of treatment with Acthar Gel). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2013.