Consequences of steroid therapy on the adaptive immune system

• Conditions: M31.6; M35.3; M31.5; Other giant cell arteritis; Polymyalgia rheumatica; Giant cell arteritis with polymyalgia rheumatica

• Registration Number: DRKS00004711
• Lead Sponsor: niversitätsklinikum FreiburgCentrum für Chronische Immundefizienz, CCI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-12-17
• Study Start: 2014-02-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

arm 1: adult RZA or PMR patient under or up to 2 months after steroid therapy
arm 2: adult patients with cataract before surgery under or up to 2 months after steroid therapy, matched for age and sex

Exclusion Criteria

- patients with existing immune defects as antibody deficiency or severe cytopenia
- further immune suppressive therapies apart from MTX, especially after Rituximab therapy
- previous or current chemotherapy
- further reumathic basic diseases
- malignoma, especially lymphoma

arm 2: in addition: steroid therapy und/or MTX therapy currently or in the previous 2 months

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum immunoglobulins, peripheral T and B cell populations under long time steroid therapy measured with nephelometry and flow cytometry

Secondary Outcome Measures

Name	Time	Method
association of changes within B and T cell population with the occurence of hypogammaglobulinaemia under steroid therapy