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Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy

NCT04640818 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2022-03-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Cladribine Oral Tablet

Treatment according to the label and medical prescription

DRUG

Rituximab

Treatment according to the label and medical prescription

DRUG

Ocrelizumab

Treatment according to the label and medical prescription

Sponsors & Collaborators

  • Merck AG Switzerland

    collaborator UNKNOWN

  • Claudio Gobbi

    lead OTHER_GOV

Principal Investigators

  • Claudio Gobbi, MD · Ospedale Regionale di Lugano, Neurocentro della Svizzera italiana, Centro Sclerosi multipla

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04640818 on ClinicalTrials.gov