CompletedPhase 4Relapsing MSNCT03135249

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

Annualized Relapse Rate (ARR) From the Time of Cessation of Natalizumab Treatment.

12 months

GroupValueIntervalNumber analysed
Alemtuzumab Treatment.0 number of relapses in a year0–09

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Alemtuzumab Treatment.90 (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

    Relapses
  • Relapse-free Period

    Baseline until progression up to 12 months

    Relapses

Other measures (3)

  • Number of New T2 Lesions

    12 months

    MRI lesions
  • Number of Enlarging T2 Lesions

    12 months

    MRI lesions
  • Number 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

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Related trials

History

    1. Started

      May 2018

    2. Main results due

      Nov 2020

    3. Finished

      Nov 2020

    4. Results posted

      Feb 2022

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