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Cladribine Tablets After Treatment With Natalizumab (CLADRINA)

StatusActive, Not Recruiting
PhasePhase 4
Started2020-02-19
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 8, 2025 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-12-04
Study Status v12
Re-verified, no change to tracked fields
2024-11-27
Study Status v11
Primary completion date2024-08-30→2026-08-30
2024-01-10
Study Status, Contacts/Locations v10
Study sites1→2
2023-09-13
Study Status, Study Description v9
Completion date2024-12→2026-12
Study description+409 characters
[...] ximum permissible washout period of no more than four weeks. After successful completion of the study, all participants in CLADRINA will be offered to participate in the CLADRINA 2-Year Extension study. During this extension trial, there will be no intervention. Patient will be followed for an additional 24 months, and their clinical and paraclinical disease [...]
2022-09-30
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2022-08-30→2024-08-30
Study sitesdetails revised at 1 of 1 site
Show 7 earlier versions
2022-07-27
Study Status, Contacts/Locations v7
Primary completion date2022-07-01→2022-08-30
2022-02-10
Study Status v6
Primary completion date2022-03→2022-07-01
Completion date2022-12→2024-12
2021-02-19
Study Status, Sponsor/Collaborators, Eligibility v5
Eligibility criteria+4 characters
[...] be eligible for enrollment in the study: Age between 18 and 5060 years, inclusive. Diagnosis of relapsing forms of MS, to in [...] es at least 28 days prior to enrollment. Weighing between 40-120 kilograms or more. Female subjects of childbearing potential must use effecti [...]
2020-02-19
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-03→confirmed 2020-02-19
Eligibility criteria-59 characters
[...] orticosteroids. Active malignancy or history of malignancy. Subjects with hereditary problems of fructose intolerance. Received a live vaccine within 6 weeks prior to cladribine t [...]
Study sitesdetails revised at 1 of 1 site
2020-01-15
Study Status, Outcome Measures v3
Re-verified, no change to tracked fields
2020-01-13
Study Status, Study Description, Outcome Measures, Eligibility, References v2
Eligibility criteria+81 characters
[...] female subjects must not be lactating or breast-feeding at screening through at least 110 weekdays after the last dose. Male subjects must be willing to use a condom induring additiondosing toand havingfor six months after the last dose. Alternatively, their female partner must use another form of contraception (such as an intra-uterine [...] al 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 [...]
Secondary endpoints2 to 1 entries
Annualized Relapse-free period Magnetic Resonance imagingRate (MRIARR) outcomes
Primary endpoints1 entry, revised
AnnualizedAbsolute relapseand Ratepercent (ARR) from the timechange of NatalizumabT treatmentcells, B cells, DC subset and NfL levels in blood.
Study description-2,560 characters
[...] ribine 10 mg tablets will be provided as commercial material re-labelled for investigational use. Treatment with cladribine tablets is intended to be initia [...] ximum permissible washout period of no more than four weeks. In patients with MS, there are encephalitogenic lymphocytes in the peripheral blood and the central nervous system (CNS) that eventually cause damage to the myelin sheath and oligodendrocytes. Natalizumab treatment sequesters encephalitogenic leukocytes out of the CNS into the peripheral blood, and [...]
Publicationsdetails revised at 39 of 39 entries
2020-01-06
Study Status, Outcome Measures v1
Re-verified, no change to tracked fields
2019-11-22
Original filing
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).
Trial Details
NCT Number NCT04178005
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: EMD Serono
Conditions Multiple Sclerosis
Enrollment 40 participants
Start Date 2020-02-19
Primary Completion 2026-08-30 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-08