SUPPRESS
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Alemtuzumab
CAMPATH-1 antigen inhibitor
Results by group
Annualized Relapse Rate (ARR) From the Time of Cessation of Natalizumab Treatment.
12 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Alemtuzumab Treatment. | 0 number of relapses in a year | 0–0 | 9 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Alemtuzumab Treatment. | 9 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Annualized Relapse Rate (ARR) From the Time of Cessation of Natalizumab Treatment.
12 months
RelapsesRelapse-free Period
Baseline until progression up to 12 months
Relapses
Other measures (3)
Number of New T2 Lesions
12 months
MRI lesionsNumber of Enlarging T2 Lesions
12 months
MRI lesionsNumber of Gadolinium (Gd)-Enhancing Lesions
12 months
MRI lesions
Who could take part
Relapsing MS · 18 to 60
Inclusion Criteria: 1. Age between 18 and 60 years, inclusive. 2. Diagnosis of relapsing forms of MS using revised McDonald Criteria1. 3. Expanded Disability Status Scale (EDSS) 0 - 5.5 (note: functional system changes in cerebral (or mental) functions and in bowel and bladder functions not used in determining EDSS for protocol eligibility). 4. Has had a minimum of 12 monthly doses of continuous natalizumab therapy (300 mg/d). 5. Understands English, and gives informed consent. Exclusion Criteria: 1. Natalizumab failure based on clinician's discretion. 2. Any prior exposure to alemtuzumab. 3. Progressive MS. 4. A diagnosis of Progressive multifocal leukoencephalopathy (PML). 5. Known hypersensitivity to alemtuzumab. 6. Initiation of new immunosuppressant treatment after the subject becomes protocol-eligible (except for corticosteroids) or enrollment in a concurrent trial with immuno-active pharmacotherapies. 7. Uncontrolled diabetes mellitus defined as HbA1c > 8% and/or requiring intensive management. 8. History of cytopenia consistent with the diagnosis of myelodysplastic syndrome. 9. Clinically significant autoimmune disease other than MS that may affect the CNS, including neuromyelitis optica (NMO), systemic lupus erythematosus (SLE), or Behcet disease. 10. Active hepatitis B or C infection or evidence of cirrhosis. 11. HIV positivity. 12. Uncontrolled viral, fungal, or bacterial infection. 13. Positive pregnancy test or inability or unwillingness to use effective means of birth control. Effective birth control is defined as: 1. Refraining from all acts of vaginal intercourse (abstinence), 2. Consistent use of birth control pills, 3. Tubal sterilization or male partner who has undergone vasectomy 4. Placement of intrauterine device 5. Use, with every act of intercourse, of a diaphragm with contraceptive jelly and/or condoms with contraceptive foam. 14. Presence of metallic objects implanted in the body that would preclude the ability of the subject to safely have MRI exams. 15. Psychiatric illness, mental deficiency, or cognitive dysfunction making compliance with treatment or informed consent impossible.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Results
Hussain RZ, Sguigna PV, Okai A, Wright C, Madinawala M, Bass AD, Cutter GR, Manouchehri N, Stuve O. The sequential natalizumab - alemtuzumab therapy in patients with relapsing forms of multiple sclerosis (SUPPRESS) trial - Part I: Rationale and objectives. J Cent Nerv Syst Dis. 2022 Aug 29;14:11795735221123911. doi: 10.1177/11795735221123911. eCollection 2022.Background
Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23. doi: 10.1056/NEJMoa044396.Background
Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910. doi: 10.1056/NEJMoa044397.Background
Stuve O, Marra CM, Bar-Or A, Niino M, Cravens PD, Cepok S, Frohman EM, Phillips JT, Arendt G, Jerome KR, Cook L, Grand'Maison F, Hemmer B, Monson NL, Racke MK. Altered CD4+/CD8+ T-cell ratios in cerebrospinal fluid of natalizumab-treated patients with multiple sclerosis. Arch Neurol. 2006 Oct;63(10):1383-7. doi: 10.1001/archneur.63.10.1383.Background
Stuve O, Marra CM, Jerome KR, Cook L, Cravens PD, Cepok S, Frohman EM, Phillips JT, Arendt G, Hemmer B, Monson NL, Racke MK. Immune surveillance in multiple sclerosis patients treated with natalizumab. Ann Neurol. 2006 May;59(5):743-7. doi: 10.1002/ana.20858.Background
Stuve O, Cravens PD, Frohman EM, Phillips JT, Remington GM, von Geldern G, Cepok S, Singh MP, Tervaert JW, De Baets M, MacManus D, Miller DH, Radu EW, Cameron EM, Monson NL, Zhang S, Kim R, Hemmer B, Racke MK. Immunologic, clinical, and radiologic status 14 months after cessation of natalizumab therapy. Neurology. 2009 Feb 3;72(5):396-401. doi: 10.1212/01.wnl.0000327341.89587.76. Epub 2008 Nov 5.Background
Kowarik MC, Pellkofer HL, Cepok S, Korn T, Kumpfel T, Buck D, Hohlfeld R, Berthele A, Hemmer B. Differential effects of fingolimod (FTY720) on immune cells in the CSF and blood of patients with MS. Neurology. 2011 Apr 5;76(14):1214-21. doi: 10.1212/WNL.0b013e3182143564.Background
del Pilar Martin M, Cravens PD, Winger R, Frohman EM, Racke MK, Eagar TN, Zamvil SS, Weber MS, Hemmer B, Karandikar NJ, Kleinschmidt-DeMasters BK, Stuve O. Decrease in the numbers of dendritic cells and CD4+ T cells in cerebral perivascular spaces due to natalizumab. Arch Neurol. 2008 Dec;65(12):1596-603. doi: 10.1001/archneur.65.12.noc80051. Epub 2008 Oct 13.Background
Bloomgren G, Richman S, Hotermans C, Subramanyam M, Goelz S, Natarajan A, Lee S, Plavina T, Scanlon JV, Sandrock A, Bozic C. Risk of natalizumab-associated progressive multifocal leukoencephalopathy. N Engl J Med. 2012 May 17;366(20):1870-80. doi: 10.1056/NEJMoa1107829.Background
Berger JR, Fox RJ. Reassessing the risk of natalizumab-associated PML. J Neurovirol. 2016 Aug;22(4):533-5. doi: 10.1007/s13365-016-0427-6. Epub 2016 Feb 3.
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History
Started
May 2018
Main results due
Nov 2020
Finished
Nov 2020
Results posted
Feb 2022
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