Cladribine After Natalizumab for Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byOlaf Stuve, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults aged 18-60 with relapsing forms of Multiple Sclerosis, including RRMS and active SPMS, who have been on natalizumab therapy for at least a year. Participants must weigh over 40 kg, not be pregnant or breastfeeding, use contraception effectively, and have no recent MS relapses. Exclusions include HIV or hepatitis infection, TB history, immunocompromised status, certain prior treatments like myelosuppressives or live vaccines recently.

Inclusion Criteria

I am not pregnant or breastfeeding.

I have been diagnosed with a relapsing form of MS.

Willing to provide voluntary and informed consent based on the Health Insurance Portability and Accountability Act (HIPPA)

+8 more

Exclusion Criteria

I am positive for HIV or hepatitis B/C.

I have been diagnosed with or suspected to have PML.

I have been treated with cladribine before.

+15 more

Participant Groups

The study tests the safety and effects of cladribine tablets in patients previously treated with natalizumab. It aims to understand how cladribine impacts the disease's progression and immune response in those with Multiple Sclerosis after switching from another treatment.

1Treatment groups

Experimental Treatment

Group I: CladribineExperimental Treatment1 Intervention

All study participants will receive treatment with cladribine 10 mg tablets at the recommended cumulative dose of 3.5 mg/kg, divided into 2 yearly treatment courses (1.75 mg/kg per treatment course). This regimen corresponds to the recommended dosage as per the USPI. Each treatment course is divided into 2 treatment cycles: * Administration of first treatment course (year 1 treatment): * First cycle: Starts on Day 1 of the study * Second cycle: Administered 23 to 27 days after the last dose of first cycle. * Administration of second treatment course (year 2 treatment): * First cycle: Administered at least 43 weeks after the last dose of year 1 treatment * Second cycle: Administered 23 to 27 days after the last dose of first cycle of year 2 treatment. The cycle dosage will be administered as 1 or 2 cladribine 10 mg tablets daily over 4 or 5 consecutive days.

Cladribine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Leustatin for: