Trial document





This trial has been registered retrospectively.
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  DRKS00004711

Trial Description

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Title

Consequences of steroid therapy on the adaptive immune system

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Steroid therapy is a reported cause of secondary hypogammaglobulinemia (www.esid.org). This is based on only few established and published data, but mainly on expert opinion. It remains questionable to what extend dosage and duration of the steroid therapy play a crucial role. Best investigations exist on a pediatric asthma cohort (Lack et al.). For Giant cell arteritis and polymyalgia rheumatica steroid therapy is the standard therapy and has to be taken in high doses and for a long time (Schmidt et al). We observed hypogammaglobulinemia at several patients under this treatment (Own observations). That is why we would like to analyze serum immunoglobulins and b- and t-lymphocyte subpopulations in the peripheral blood with the help of nephelometry and flow cytometry respectively in a cross-sectional study. Then we want to correlate these data with anamnestic parameters concerning susceptibility to infections, dosage and duration of the steroid therapy. The data of lymphocyte subpopulations will be compared to an age and gender matched control group of patients awaiting cataract surgery. The phenotyping of lymphocyte subpopulations is expected to examine whether b-cell differentiation is disturbed under steroid treatment and if this is possibly linked with altered serum immunoglobulin levels. The investigations should also help to distinguish between steroid induced hypogammaglobulinemia and changes in the b-cell system occurring within the framework of primary antibody deficiencies (Wehr et al.).

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Brief Summary in Scientific Language

Nephelometric measurement of serum immunoglobulins and flow cytometric phenotypisation of b- and t-cell lymphocytes in the peripheral blood of patients presenting with giant cell arteritis and/or polymyalgia rheumatica in order to examine the consequences of steroid therapy on the adaptive immune system. Correlation to anamnestic parameters concerning susceptibility to infections, dosage and duration of the steroid therapy.

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Organizational Data

  •   DRKS00004711
  •   2014/02/26
  •   [---]*
  •   yes
  •   Approved
  •   211/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M31.6 -  Other giant cell arteritis
  •   M35.3 -  Polymyalgia rheumatica
  •   M31.5 -  Giant cell arteritis with polymyalgia rheumatica
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Interventions/Observational Groups

  •   Effects of steroid therapy on the homoeostasis of the specific cellular immunesystem and the homoral immunity in patients with RZA and PMR.
    After informed consent 8ml EDTA blood and 8ml serum were taken from patients during their regular visit. The isolated peripheral blood mononuclear cells were analyzed by flow cytometry for surface markers in order to differentiate B and T cell populations. The serum was analyzed for IgG, IgA and IgM titers.
  •   Effects of steroid therapy on the homoeostasis of the specific cellular immunesystem and the homoral immunity in patients with cataract before surgery.
    After informed consent 8ml EDTA blood and 8ml serum were taken from patients during their regular visit. The isolated peripheral blood mononuclear cells were analyzed by flow cytometry for surface markers in order to differentiate B and T cell populations. The serum was analyzed for IgG, IgA and IgM titers.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/30
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   90   Years
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg Centrum für Chronische Immundefizienz, CCI
    • Mr.  Prof. Dr. med.  Klaus  Warnatz 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Centrum für Chronische Immundefizienz, CCI
    • Mr.  Prof. Dr. med.  Klaus  Warnatz 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Centrum für Chronische Immundefizienz, CCI
    • Mr.  Prof. Dr. med.  Klaus  Warnatz 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreiburgCentrum für Chronische Immundefizienz (CCI)
    • Mr.  Prof. Dr. med.   Klaus   Warnatz 
    • Breisacher Str. 117
    • 79106  Freiburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/17
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Trial Publications, Results and other Documents

  •   Wirsum et al. J Clin Immunol. 2016 May;36(4):406-12. doi: 10.1007/s10875-016-0264-7. Epub 2016 Mar 15. PubMed PMID: 26980224
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* This entry means the parameter is not applicable or has not been set.