Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy

Sponsor
Claudio Gobbi
Study ID
NCT04640818
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cladribine Oral Tablet — DRUG
    Treatment according to the label and medical prescription
  • Rituximab — DRUG
    Treatment according to the label and medical prescription
  • Ocrelizumab — DRUG
    Treatment according to the label and medical prescription

Study Details

Prolonged anti CD20 therapy for the treatment of active multiple sclerosis leading to continuous B cell depletion is associated with hypogammaglobulinemia predisposing to a potentially increased risk of serious infections, particularly in the more disabled and aged patients. No data have been published on the sequential use of anti CD20 therapies and cladribine, that is thought to act as an immune reconstitution agent. his study aims at investigating IgG and IgM serum concentration changes at 6 and 12 months after switching to cladribine in patients previously treated with anti CD20 therapies (ie, ocrelizumab ≥1.8 gr or rituximab 3.0 gr) for ≥18 months, as compared to continued anti CD20 therapies.

Key Dates

Start date
Dec 17, 2020
Status verified
Mar 2022
Primary completion
Oct 31, 2022
Completion
Oct 31, 2022

Study Design

Enrollment
45 participants (estimated)

Arms

  • Arm: CLAD-GROUP
    Patients with cladribine therapy
  • Arm: CD20-GROUP
    Patients with anti CD20 therapy (ocrelizumab or rituximab)

Primary Outcome Measure

Changes in IgG serum concentrations in Cald-Group [ Time Frame: 6 months ]

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