Cladribine Tablets After Treatment With Natalizumab (CLADRINA)

STATUS

Recruiting
End date

Dec 26, 2024
participants needed

40
sponsor

University of Texas Southwestern Medical Center

Send

Updated on 26 March 2022

See if I qualify

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
Treatment	cladribine
Clinical Study Identifier	NCT04178005
Sponsor	University of Texas Southwestern Medical Center
Last Modified on	26 March 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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)
	Negative history for any relapses at least 28 days prior to enrollment
	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
	Weighing between 40 kilograms or more
	every-4-week infusion)
	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
	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
	Patients who meet any of the following exclusion criteria will not be eligible for
	Active malignancy or history of malignancy
	enrollment in the study
	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
	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)

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

0/250

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

natalizumab

cladribine

chronic progressive multiple sclerosis

relapsing multiple sclerosis

secondary progressive multiple sclerosis

natalizumab therapy

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Edit Delete

Added by •

•

Private

Edit Delete

Reply by • • Private

Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

Enter the passcode

The passcode will expire in None.

Cladribine Tablets After Treatment With Natalizumab (CLADRINA)