MSFrontier

Oral Cladribine B-cell Study

Oral Cladribine B-cell Study
CompletedMS (type not specified)NCT06415864

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

Results by group

Percent Change in Class-switched Memory B Cells From Baseline to Week 96 nh

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)-62.8 % change-99.98–16010

Percent Change in Non Class-switched Memory B Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)-85.3 % change-99.98–134.4410

Percent Change in Plasmablast From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)117.2 % change-87.3–225010

Percent Change in Transitional B Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)858.6 % change-86.05–235010

Percent Change in Regulatory B Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)648.3 % change-93.52–4665010

Percent Change in CD4+ Central Memory T Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)-55 % change-94.64–226.8810

Percent Change in CD4+ Naive T Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)-47.1 % change-99.74–1472.9710

Percent Change in CD4+ TEMRA Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)30.4 % change-96.95–156010

Percent Change in CD4+ Effector Memory T Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)0.82 % change-96.9–234.2510

Percent Change in CD8+ Central Memory T Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)26 Percentage change-94.24–251.5710

Percent Change in CD8+ Naive T Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)-25 % change-89.67–205010

Percent Change in CD8+ TEMRA Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)60.81 % change-52.84–3006.2510

Percent Change in CD8+ TEM Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)4.56 % change-95.53–726.4810

Percent Change in Regulatory T Cells From Baseline to Week 96

Baseline to week 96

GroupValueIntervalNumber analysed
Cladribine (Mavenclad, Merck Serono Ltd)40.02 % change-88.52–68010

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Cladribine (Mavenclad, Merck Serono Ltd)100 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Percent Change in Class-switched Memory B Cells From Baseline to Week 96 nh

    Baseline to week 96

    Thinking and memoryImmune response

  • Percent Change in Non Class-switched Memory B Cells From Baseline to Week 96

    Baseline to week 96

    Thinking and memoryImmune response

  • Percent Change in Plasmablast From Baseline to Week 96

    Baseline to week 96

    Immune response

  • Percent Change in Transitional B Cells From Baseline to Week 96

    Baseline to week 96

    Immune response

  • Percent Change in Regulatory B Cells From Baseline to Week 96

    Baseline to week 96

    Immune response

  • Percent Change in CD4+ Central Memory T Cells From Baseline to Week 96

    Baseline to week 96

    Thinking and memoryImmune response

  • Percent Change in CD4+ Naive T Cells From Baseline to Week 96

    Baseline to week 96

    Immune response

  • Percent Change in CD4+ TEMRA Cells From Baseline to Week 96

    Baseline to week 96

    Immune response

  • Percent Change in CD4+ Effector Memory T Cells From Baseline to Week 96

    Baseline to week 96

    Thinking and memoryImmune response

  • Percent Change in CD8+ Central Memory T Cells From Baseline to Week 96

    Baseline to week 96

    Thinking and memoryImmune response

  • Percent Change in CD8+ Naive T Cells From Baseline to Week 96

    Baseline to week 96

    Immune response

  • Percent Change in CD8+ TEMRA Cells From Baseline to Week 96

    Baseline to week 96

    Immune response

  • Percent Change in CD8+ TEM Cells From Baseline to Week 96

    Baseline to week 96

    Thinking and memoryImmune response

  • Percent Change in Regulatory T Cells From Baseline to Week 96

    Baseline to week 96

    Immune response

Other measures (8)

  • Changes in CSF of κ Free Light Chain (KFLC) From Baseline to Week 48 and Week 96

    Baseline to week 96

    Blood or spinal fluid markers

  • Change in CSF Oligoclonal Band (OCB) Positivity From Baseline to Week 48 and Week 96

    Baseline to week 96

    Blood or spinal fluid markers

  • Changes in CSF of λ Free Light Chain (LFLC) Index From Baseline to Week 48 and Week 96

    Baseline to week 96

    Blood or spinal fluid markers

  • Change in CSF CXCL-13 Levels From Baseline to Week 96

    Baseline to week 96

    Blood or spinal fluid markers

  • Change in Urine Neopterin Levels From Baseline to Week 96

    Baseline to week 96

  • Change in CSF Neurofilament Light Chain (NfL) Levels From Baseline to Week 96

    Baseline to 96 weeks

    Blood or spinal fluid markers

  • Change in CSF Soluble CD138 Levels From Baseline to Week 96

    Baseline to week 96

    Blood or spinal fluid markersImmune response

  • Changes in CSF Cytokine and Chemokine Levels From Baseline to Week 96

    Baseline to week 96

    Blood or spinal fluid markersImmune response

Who could take part

MS (type not specified)

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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

To study the impact of cladribine on peripheral and intrathecal B-cell, plasma cells, T cells and Tregs

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History

    1. Started

      Jul 2019

    2. Main results due

      Jan 2024

    3. Finished

      Jan 2024

    4. Results posted

      Feb 2026

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