Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy

NCT ID: NCT04640818

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-17
• Study Completion Date: 2022-10-31

Brief 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.

Detailed Description

The study population will include patients with remitting relapsing multiple sclerosis consulting the Multiple Sclerosis Center of Neurocenter of Southern Switzerland.

Enrolled patients will have 5 Study Visits, one every 3 months according to clinical practice. At visits at 3 and 6 months only adverse events will be collected for study purposes. Clinical assessments will be performed at baseline, Month 6 and Month 12. Clinical assessments correspond to medical exams performed routinely in MS patients treated with anti CD20 or cladribine therapy: clinical assessments, monitoring haemoglobin parameters, serum immunoglobulins, liver and renal function.(6, 12 months), radiological disability progression and biomarker of ongoing neurodegeneration (12 months).

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CLAD-GROUP

Patients with cladribine therapy

Cladribine Oral Tablet

Intervention Type: DRUG

Treatment according to the label and medical prescription

CD20-GROUP

Patients with anti CD20 therapy (ocrelizumab or rituximab)

Rituximab

Intervention Type: DRUG

Treatment according to the label and medical prescription

Ocrelizumab

Intervention Type: DRUG

Treatment according to the label and medical prescription

Interventions

Cladribine Oral Tablet

Treatment according to the label and medical prescription

Intervention Type: DRUG

Rituximab

Treatment according to the label and medical prescription

Intervention Type: DRUG

Ocrelizumab

Treatment according to the label and medical prescription

Intervention Type: DRUG

Other Intervention Names

Mavenclade; Mabthera, Rixathon; Ocrevus

Eligibility Criteria

Inclusion Criteria

• Relapsing MS according to Lublin;
• Treatment with ocrelizumab or rituximab for ≥18 months and having received 1.8 / 3.0 gr, respectively;
• CLAD_GROUP: Planning to switch to cladribine because of concerns about increased risks of infections related to hypogammaglobulinemia developing during long term anti CD20 therapies or a documented decrease of ≥10% IgG and/or IgM compared to pre- anti CD20 therapy;
• or CD20_GROUP: no need to stop CD20 therapy due decrease of ≥10% IgG and/or IgM, or increased risk of infections related to hypogammaglobulinemia or other reasons, continued anti CD20 therapies clinically indicated;
• EDSS ≤7.0;
• Age >18 years.

Exclusion Criteria

• Non relapsing MS;
• Pregnancy - breastfeeding;
• Contraindications to perform MRI;
• Contraindication to receive cladribine or to continue anti CD therapies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck AG Switzerland

UNKNOWN

Sponsor Role: collaborator

Claudio Gobbi

OTHER_GOV

Sponsor Role: lead

Responsible Party

Claudio Gobbi

Head Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudio Gobbi, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Regionale di Lugano, Neurocentro della Svizzera italiana, Centro Sclerosi multipla

Locations

Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano

Lugano, Canton Ticino, Switzerland

Countries

Switzerland

Other Identifiers

EOCNSIMS.2001

Identifier Type: -

Identifier Source: org_study_id