A Phase 4 interventional study of Alemtuzumab in Multiple Sclerosis (MS), sponsored by University of Texas Southwestern Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Treatment
The purpose of this study is to determine if a sequential combination therapy of natalizumab and alemtuzumab induces peripheral tolerance and reduces the annualized relapse rate (ARR) in patients with relapsing-remitting multiple sclerosis (RRMS).
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 9 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Positive pregnancy test or inability or unwillingness to use effective means of birth control. Effective birth control is defined as:
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.
Drug: Alemtuzumab
Alemtuzumab is a humanized monoclonal therapeutic antibody that rapidly depletes cluster of differentiation 52 (CD52)+ cells.
Also known as: Lemtrada
Annualized Relapse Rate (ARR) From the Time of Cessation of Natalizumab Treatment.
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. ARR was the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study.
Time frame: 12 months
Relapse-free Period
Relapse free period, number of months until relapse, was measured only among participants who may relapse.
Time frame: Baseline until progression up to 12 months
Number of New T2 Lesions
Number of new T2 lesions as measured by MRI.
Time frame: 12 months
Number of Enlarging T2 Lesions
Number of enlarging T2 lesions as measured by MRI.
Time frame: 12 months
Number of Gadolinium (Gd)-Enhancing Lesions
Number of gadolinium (Gd)-enhancing lesions as measured by MRI.
Time frame: 12 months
Neurological Disability Outcome
Neurological disability The Expanded Disability Status Scale (EDSS) will be utilized to measure the accumulation of neurological disability. The EDSS is a scale providing a disability score (0 to 10) based on neurological examination and information about how the patient is able to perform tasks such as long walking. Higher the score, worse the outcomes.
Time frame: 12 months
Quality of Life Outcome
Quality of life (QoL) will be measured by a pre-defined, self-administered testing battery. It measures the pleasure one derives from being able to do their work well, feelings of hopelessness and difficulties in dealing with work or in doing their job effectively, and work-related, secondary exposure to extremely stressful events. Possible scores range from 0-100, with higher scores indicating a better quality of life.
Time frame: 12 months
| Milestone | Alemtuzumab Treatment. |
|---|---|
| Started | 9 |
| Completed | 7 |
| Not completed | 2 |
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. ARR was the number of confirmed relapses in a year, calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of time in study.
| number of relapses in a year | Alemtuzumab Treatment. |
|---|---|
| Annualized Relapse Rate (ARR) From the Time of Cessation of Natalizumab Treatment. | 0 (0 to 0) |
Relapse free period, number of months until relapse, was measured only among participants who may relapse.
No measurements were reported for this outcome.
Number of new T2 lesions as measured by MRI.
| lesions | Alemtuzumab Treatment. |
|---|---|
| Number of New T2 Lesions | 0 ± 0 |
Number of enlarging T2 lesions as measured by MRI.
| lesions | Alemtuzumab Treatment. |
|---|---|
| Number of Enlarging T2 Lesions | 0 ± 0 |
Number of gadolinium (Gd)-enhancing lesions as measured by MRI.
| lesions | Alemtuzumab Treatment. |
|---|---|
| Number of Gadolinium (Gd)-Enhancing Lesions | 0 ± 0 |
Neurological disability The Expanded Disability Status Scale (EDSS) will be utilized to measure the accumulation of neurological disability. The EDSS is a scale providing a disability score (0 to 10) based on neurological examination and information about how the patient is able to perform tasks such as long walking. Higher the score, worse the outcomes.
| score on a scale | Alemtuzumab Treatment. |
|---|---|
| Neurological Disability Outcome | 3.14 ± 1.49 |
Quality of life (QoL) will be measured by a pre-defined, self-administered testing battery. It measures the pleasure one derives from being able to do their work well, feelings of hopelessness and difficulties in dealing with work or in doing their job effectively, and work-related, secondary exposure to extremely stressful events. Possible scores range from 0-100, with higher scores indicating a better quality of life.
| score on a scale | Alemtuzumab Treatment. |
|---|---|
| Quality of Life Outcome | 71.38 ± 21.04 |
Collected over Up to 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alemtuzumab Treatment. | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Alemtuzumab Treatment. |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Alemtuzumab Treatment. |
|---|---|
| Female | 7 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Alemtuzumab Treatment. |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Alemtuzumab Treatment. |
|---|---|
| United States | 9 |
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University of Texas Southwestern Medical Center