MS Drug's immune impact revealed in small study
NCT ID NCT06415864
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how the oral medication cladribine changes different types of immune cells in people with relapsing-remitting multiple sclerosis (RRMS). Ten participants provided blood and spinal fluid samples over 96 weeks to track changes in B cells, T cells, and other immune markers. The goal was to better understand how cladribine works in the body, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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10 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Jan 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Relapsing-remitting MS
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with MS who are being treated with oral cladribine at Barts Health NHS Trust will be approached to participate in this study. * Patients must be willing and able to undergo lumbar punctures * Patients who are OCB positive in their CSF (previous diagnostic lumbar puncture) Exclusion Criteria: * Ineligible for oral cladribine under NHS England prescribing guidelines and those participating in MAGNIFY-MS study (cladribine tablets in active MS) * Unsuitable to have a lumbar puncture, for example spinal deformity, tethered cord syndrome or the use of aspirin or anticoagulants, and those unable to comply with study requirements, including frequency of visits and lumbar punctures. * Presence of comorbidities in which the administration of cladribine is contraindicated. * Abnormal baseline investigations (WBC\<3 x 10\*9/l, lymphocytes \<1.0 x 10\*9/l, neutrophil count \<1.5 x 10\*9/l, platelet count \<100 x 10\*9, haemoglobin \<110g/l, LFT\>/3x upper limit of normal of site reference ranges, potassium \<2.8mmol/l or \>5.5mmol/l, sodium \<125 mmol/l, creatinine \>130 umol/l)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barts Health NHS Trust
London, United Kingdom
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