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The different aspects of B cell biology in arthritis.

The different aspects of B cell biology in arthritis. - The different aspects of B cell biology in arthritis.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38525
Enrollment
250
Registered
2013-11-28
Start date
2014-01-17
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Rheumatic diseases

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All RA and OA patients older than 18 years that have the ability to understand the patient information form and have signed the written informed consent form. RA patients: RA as diagnosed by a rheumatologist, biologic naïve patients, DAS44 score >1.6 to ensure active disease . OA patients: OA as diagnosed by a rheumatologist.

Exclusion criteria

Exclusion criteria: Individuals who fail to meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
1) Heparinized peripheral blood: a) different cell types will be isolated from the heparinized/citrate blood tubes after a first isolation step using Ficoll (peripheral blood mononuclear cells) and subsequent purification using beads/cell sorting using standardized protocols. b) cells will be characterized phenotypically in the absence/presence of different stimuli using cell type-specific stimuli c) Isolated B cells/total PBMCs will be cultured in our in-vitro culture system to study the effects of CD40-blockade or other compunds on the development of autoantibody-producing B cells in RA d) cells that are left over, will be stored in liquid nitrogen to enable validation of the results in a follow-up experiment. 2) Citrate peripheral blood: a) Platelet poor plasma will be stored at -20 degrees and used to determine levels of sCD40L and other cytokines b) Platelet phenotype will be determined in the absence/presence of platelet agonists (ADP, TRAP) 3) Serum/plasma a) Serum/plasma will be obtained by centrifugation of the gel-tube and collecting the upper cell-free layer. b) Serum/plasma will be either used immediately for measurements of different factors, the isolation of autoantibodies or will be stored at -70 degrees for later use. 4) Synovial fluid a) The cellular component will be isolated using centrifugation and cells will be used in the described in vitro techniques; analyzed by flow cytometry or stored in liquid nitrogen for later use. b) The non-cellular component will be used to determine autoantibody levels and to isolate autoantibodies for glycosylation analysis. Serum, plasma, synovial fluid and cells such as B cells, T cells and monocytes that are left over will be stored for max. 15 years.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)