Rituximab in pediatric rheumatic diseases: 2 years follow up for immunological long-term effects using a standardized screening and safety protocol.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00020514

Enrollment

Registered

2020-01-17

Start date

2011-08-05

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M08.0 M32.1

Interventions

Group 1: single-arm study. All patients enrolled received treatment with anti-CD20 antibodies.

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Severe and/or refractory pediatric rheumatic diseases based on antobody-mediated pathogenesis.

Exclusion criteria

Exclusion criteria: Acute and severe infection. Primary immunodeficiency.

Design outcomes

Primary

Measure	Time frame
Aims: 1. Long-term follow up concerning the renewal of B cell fraction and function following treatment with anti-CD20 monoclonal antibodies using immunological parameters. 2. Monitoring of infectious complications and other adverse effects. 3. Efficacy according to international criteria for remission of pediatric rheumatic diseases. Execution of the study: Statistical analysis was performed using demographic, clinical ans immunological parameters. Patients were followed up for at least 2 years posttreatment. Specifications of the "screening and safety" protocol predefined all necessary examinations (lab tests and instrument-based diagnostics). Evaluation periods were 3-6 months. We observed standard lab tests such as differential blood count, immunofluorescence staining for flow cytometry analysis (FACS) testing for humoral immunity like immunoglobulins, vaccination titers, autoantibodies, hemisoagglutinins and functional immunologic tests. Instrument-based diagnostics: lung function testing and sonography spleen.	—

Measure

Time frame

Aims: 1. Long-term follow up concerning the renewal of B cell fraction and function following treatment with anti-CD20 monoclonal antibodies using immunological parameters. 2. Monitoring of infectious complications and other adverse effects. 3. Efficacy according to international criteria for remission of pediatric rheumatic diseases. Execution of the study: Statistical analysis was performed using demographic, clinical ans immunological parameters. Patients were followed up for at least 2 years posttreatment. Specifications of the "screening and safety" protocol predefined all necessary examinations (lab tests and instrument-based diagnostics). Evaluation periods were 3-6 months. We observed standard lab tests such as differential blood count, immunofluorescence staining for flow cytometry analysis (FACS) testing for humoral immunity like immunoglobulins, vaccination titers, autoantibodies, hemisoagglutinins and functional immunologic tests. Instrument-based diagnostics: lung function testing and sonography spleen.

—

Countries

Germany

Contacts

Public ContactFabian Speth

Universitätskinderklinik Rostock

fabspeth@gmx.de0381-494-7011

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026