Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis (SUPPRESS)
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|ClinicalTrials.gov Identifier: NCT03135249|
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : December 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis (MS)||Drug: Alemtuzumab||Phase 4|
To determine if treatment with alemtuzumab after natalizumab reduces the ARR in patients with RRMS. The goal of this trial is to establish a disease-free state over a 24 months period in patients who received the natalizumab-alemtuzumab sequential therapy. The target population for this study are RRMS patients nearing the end of their natalizumab treatment regimen.Participants will be recruited from four different sites. Patients who meet all inclusion/exclusion criteria will be eligible for enrollment in the study.
Alemtuzumab (Lemtrada®) will be administered at a dose of 12 mg/d by intravenous (i.v.) infusion every day for five consecutive days within 14 days of the last dose of natalizumab. After 12 months, patients will be treated with a second course of alemtuzumab 12 mg/d by intravenous (i.v.) infusion every day for three consecutive days, and participants will be followed open-label for another 12 months per standard of care. Outside the scope of this study, the intention is to follow all study participants in participating centers long-term, and to record disease activity and treatment response.
Natalizumab treatment sequesters leukocytes out of the central nervous system (CNS) into the peripheral blood. Immediate sequential alemtuzumab therapy will deplete these cells more completely than alemtuzumab monotherapy, and prevent reactivation of disease activity previously treated with natalizumab. Thus, investigators hypothesize that sequential natalizumab - alemtuzumab therapy will prevent disease activation after cessation of natalizumab, and will provide sustained disease remission in many patients.
Clinical follow up by the treating physician will occur at months 0, 3, 6, 9, 12, 18 and 24 or immediately following clinical exacerbations months. During clinical visits, comprehensive medical history data will be obtained by the treating physician. Clinical visits due to suspected exacerbations associated with CNS (central nervous system) demyelination, and associated diagnostic studies and treatments, will be covered under the medical standard of care by third party payers. A recommendation to reevaluate the patient within 3 months following the clinical event to assess for extent of recovery will be made.
Standardized MRI studies of the brain will be performed at 0, 6, 12 and 24 months. Clinical imaging studies of the brain will be performed during or immediately following the onset of a clinical exacerbation will be performed at the discretion of the site PI with scan costs covered under the medical standard of care. An end of study clinical MRI of the brain with and without contrast will be recommended to study participants at week 96 as medical standard of care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||To determine if treatment with alemtuzumab after natalizumab maintains or reduces the ARR in patients with RRMS. The goal of this trial is to establish a disease-free state over a 24 months period in patients who received the natalizumab-alemtuzumab sequential therapy.|
|Masking:||None (Open Label)|
|Official Title:||Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis (SUPPRESS)|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||November 4, 2020|
|Actual Study Completion Date :||November 4, 2020|
Patients with relapsing-remitting multiple sclerosis previously treated with natalizumab, the following treatment arms with alemtuzumab will be implemented:
Year One: Alemtuzumab 12 mg (1.2 ml) IV Infusion via pump over a minimum of four hours daily for five days to be given within eight hours after dilution.
Year Two: Alemtuzumab 12 mg (1.2 ml) IV Infusion via pump over a minimum of four hours daily for three days to be given within eight hours after dilution.
Alemtuzumab is a humanized monoclonal therapeutic antibody that rapidly depletes cluster of differentiation 52 (CD52)+ cells.
Other Name: Lemtrada
- Annualized relapse rate (ARR) from the time of cessation of natalizumab treatment. [ Time Frame: 2 years ]To determine if treatment with alemtuzumab after natalizumab maintains or reduces the ARR in patients with RRMS. The goal of this trial is to establish a disease-free state over a 24 months period in patients who received the natalizumab-alemtuzumab sequential therapy.
- Relapse-free period [ Time Frame: 12 months ]To determine the freedom of relapse
- Magnetic resonance imaging outcomes [ Time Frame: 24 months ]To determine the number of new/enlarging T2 lesions, and the number of gadolinium (Gd)-enhancing lesions
- Neurological disability outcome [ Time Frame: 24 months ]The Expanded Disability Status Scale (EDSS) will be utilized to measure the accumulation of neurological disability
- Anterior visual pathway outcome [ Time Frame: 24 months ]To determine the effect on the retinal nerve fiber layer (RNFL), optic coherence tomography (OCT) will be performed.
- Quality of Life outcome [ Time Frame: 24 months ]Quality of life (QoL) will be measures by a pre-defined, self-administered testing battery.
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): NCT03135249
|United States, Texas|
|VA North Texas Health Care System|
|Dallas, Texas, United States, 75216|
|UT Southwestern Medical center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Olaf Stuve, M.D., Ph.D.||UT Southwestern Medical Center|