Cladribine Tablets After Treatment With Natalizumab (CLADRINA)

  • STATUS
    Recruiting
  • End date
    Dec 3, 2022
  • participants needed
    40
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 3 March 2021
natalizumab
cladribine
chronic progressive multiple sclerosis
relapsing multiple sclerosis
secondary progressive multiple sclerosis
natalizumab therapy

Summary

The purpose of this study is to generate hypotheses regarding the safety, efficacy, and immunological impact of cladribine tablets after treatment with natalizumab in patients with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (active SPMS).

Description

This will be an open label, single arm, multicenter, collaborative phase 4 research study, designed to generate hypotheses regarding the transition to cladribine tablets after treatment with natalizumab in patients with relapsing forms of multiple sclerosis MS, to include relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS).

The total duration of this interventional study will be 2 years, but patients who require additional time (up to 6 months) for recovery of Absolute lymphocyte count (ALC) to 800 cells/ul prior to the second treatment course will be followed for up to 6 additional months in order to have a full second year of follow up after initiation of the second year's treatment course (for a total study duration of up to 30 months in some patients). A total of 40 study participants with relapsing forms of MS, to include RRMS and active SPMS, who meet the criteria for treatment with cladribine tablets as per the approved United States Prescribing Information (USPI) are planned to be enrolled at up to three centers in the United States. All study participants will receive treatment with cladribine 10 mg tablets during year 1 and year 2 according to the approved USPI (EMD Serono, 2019). Cladribine 10 mg tablets will be provided as commercial material. Treatment with cladribine tablets is intended to be initiated approximately 14 days after the last infusion of natalizumab (e.g., a 14-day "washout"), with a maximum permissible washout period of no more than four weeks.

Details
Condition Multiple Sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave, multiple sclerosis (ms)
Treatment cladribine
Clinical Study IdentifierNCT04178005
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on3 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 50 yrs?
Gender: Male or Female
Do you have any of these conditions: Radiologically Isolated Syndrome or Multiple Sclerosis or Dermatite Atopique modérée ou grave?
Do you have any of these conditions: Dermatite Atopique modérée ou grave or Radiologically Isolated Syndrome or multiple sclerosis (ms) or Multiple Sclerosis?
Is your age between 18 yrs and 60 yrs?
Do you have any of these conditions: multiple sclerosis (ms) or Radiologically Isolated Syndrome or Dermatite Atopique modérée ou grave or Multiple Sclerosis?
Patients who meet the following inclusion criteria will be eligible for
enrollment in the
study
Age between 18 and 60 years, inclusive
Diagnosis of relapsing forms of MS, to include RRMS and active SPMS, diagnosed with McDonald Criteria 2005, 2010, and/or 2017 (1-3)
EDSS 0 - 5.5 (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 months of continuous natalizumab therapy (300 mg/d), including patients receiving extended interval dosing of natalizumab (e.g., less frequently than every-4-week infusion)
Negative history for any relapses at least 28 days prior to enrollment
Weighing between 40 kilograms or more
Female subjects of childbearing potential must use effective methods of contraception to prevent pregnancy for 4 weeks before initiation of cladribine tablets and must agree to continue to practice adequate contraception for at least 6 months after the last dose. Women using systemically acting hormonal contraceptives should add a barrier method during cladribine treatment and for at least 4 weeks after the last dose in each treatment year
Female subjects must not be pregnant; female subjects must not be lactating or breast-feeding at least 10 days after the last dose
Male subjects must be willing to use a condom during dosing and for six months after the last dose. Alternatively, their female partner must use another form of contraception (such as an intra-uterine device [IUD], barrier method with spermicide, or hormonal contraceptive [e.g., implant, injectable, patch or oral]) during dosing and for six months after last dose
Understands and is capable of following through with study protocol requirements and assessments
Willing to provide voluntary and informed consent based on the Health Insurance Portability and Accountability Act (HIPPA)

Exclusion Criteria

Patients who meet any of the following exclusion criteria will not be eligible
for enrollment in the study
Natalizumab failure based on clinician's discretion
Not active progressive MS (4)
A diagnosis of PML or any suspicion of PML
A diagnosis of Clinically Isolated Syndrome
Known hypersensitivity to cladribine
Any prior exposure to cladribine
Lymphocyte count not within normal limits of the local, hospital laboratory
Previous or current exposure to mitoxantrone, azathioprine, methotrexate, cyclophosphamide, myelosuppressive treatments, total lymphoid irradiation
Receiving oral or systemic corticosteroid treatments within the 28 days prior to enrollment
Receiving cytokine base treatment, Intra Venous Immuno Globulin (IVIG) or Plasma pheresis, 3 months prior to enrollment in the study
Having platelet count or neutrophil count below the lower limit of the normal range within the 28 days prior to enrollment in the study
Positive for HIV, or positive hepatitis C antibody test or hepatitis B surface antigen test and/or core antibody test for IgG and/or IgM
History of tuberculosis (TB), presence of active tuberculosis, or latent tuberculosis as detected by local standard of practice like imaging (e.g., chest X-ray, chest CT scan, MRI) and/or positive QuantiFERON-TB Gold test and/or skin test and/or clinical examination or has had latent TB disease at any time in the past
Immunocompromised subjects, including subjects currently receiving immunosuppressive or myelosuppressive therapy with, e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids
Active malignancy or history of malignancy
Received a live vaccine within 6 weeks prior to cladribine tablet administration or intends to receive a live vaccination during the trial. After the last dose of cladribine tablets, the subject should avoid live vaccine as long as the subject's white blood cell counts are not within normal limits
Allergy or hypersensitivity to gadolinium and/or any other contraindication to perform an MRI
Has any renal condition that would preclude the administration of gadolinium (e.g. acute or chronic severe renal insufficiency (GFR < 30 mL/min/1.73m2)
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