CompletedPhase 4

Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis

United States9 participantsStarted 2018-05-01

Plain-language summary

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).

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Age between 18 and 60 years, inclusive.
✓. Diagnosis of relapsing forms of MS using revised McDonald Criteria1.
✓. 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).
✓. Has had a minimum of 12 monthly doses of continuous natalizumab therapy (300 mg/d).
✓. Understands English, and gives informed consent.

Exclusion criteria

✕. Natalizumab failure based on clinician's discretion.
✕. Any prior exposure to alemtuzumab.
✕. Progressive MS.
✕. A diagnosis of Progressive multifocal leukoencephalopathy (PML).
✕. Known hypersensitivity to alemtuzumab.
✕. Initiation of new immunosuppressant treatment after the subject becomes protocol-eligible (except for corticosteroids) or enrollment in a concurrent trial with immuno-active pharmacotherapies.
✕. Uncontrolled diabetes mellitus defined as HbA1c \> 8% and/or requiring intensive management.
✕. History of cytopenia consistent with the diagnosis of myelodysplastic syndrome.

What they're measuring

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

Timeframe: 12 months

Relapse-free Period

Timeframe: Baseline until progression up to 12 months

Trial details

NCT IDNCT03135249

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-04

Results submitted2021-09-02

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