Oral Cladribine B-cell Study

NCT06415864 | Completed Results

• 1 other identifier: 262436
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

MS

Outcome Measures

Primary Outcomes (14)

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

  Percent change from baseline to Week 96 in class-switched memory B cells (CD19+/CD27+/IgD-) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in non class-switched memory B cells (CD19+/CD27+/IgD+) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

• Percent Change in Plasmablast From Baseline to Week 96

  Percent change from baseline to Week 96 in plasmablasts (CD19+/CD27+/CD38+) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in transitional B cells (CD19+ IgD+ CD10+ CD27-) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in regulatory B cells (CD19+/CD24+/CD38+) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in CD4+ central memory T cells (CD45RA- CCR7+) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in CD4+ naive T cells (CD45RA+ CCR7+) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in CD4+ TEMRA cells (CD45RA+ CCR7-) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in CD4+ effector memory T cells (CD45RA- CCR7-) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in CD8+ central memory T cells (CD45RA- CCR7+) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in CD8+ naive T cells (CD45RA+ CCR7+) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in CD8+ TEMRA cells (CD45RA+ CCR7-) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in CD8+ effector memory T cells (CD45RA- CCR7-) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

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

  Percent change from baseline to Week 96 in regulatory T cells (CD4+ CD25+ FOXP3+) in participants with RRMS treated with oral cladribine.

  Baseline to week 96

Secondary Outcomes (8)

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

  Baseline to week 96

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

  Baseline to week 96

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

  Baseline to week 96

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

  Baseline to week 96

• Change in Urine Neopterin Levels From Baseline to Week 96

  Baseline to week 96

Study Arms (1)

Cladribine (Mavenclad, Merck Serono Ltd)

In the summary of product characteristics the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Relapsing-remitting MS

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Health NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr Sharmilee Gnanapavan
• Organization: Queen Mary University

sharmilee.gnanapavan@nhs.net

02073777000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: May 16, 2024
• Study Start: July 1, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)