Unraveling Incomplete Lupus - search for prognostic factors for progression to Systemic Lupus Erythematosus

Unraveling Incomplete Lupus - search for prognostic factors for progression to Systemic Lupus Erythematosus - Unraveling Incomplete Lupus

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45013

Enrollment

143

Registered

2015-12-24

Start date

2016-03-09

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

lupus SLE

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Incomplete Lupus patients: - ANA positivity with a titre of at least 1:80 or higher - Two other ACR criteria of SLE - Disease duration of

Exclusion criteria

Exclusion criteria: - Concomitant chronic diseases that may affect immune system (such as prior or current malignant disease, active infectious disease, other rheumatological disease, kidney disease, active allergy etc.) - Pregnancy -

Design outcomes

Primary

Measure	Time frame
The main parameter is expression of IFN type I signature	—

Secondary

Measure	Time frame
- Other parameters of increased innate immune system activation will be measured including levels of MxA in monocytes and serum, TLR protein expression by FACS and TLR mRNA expression by RT-PCR, and serological biomarkers (a.o. TNF alpha, IL-6 and CXCL-10) will be assessed with luminex - As marker of inflammation and apoptosis, levels of HMGB-1 will be determined. - Production of different auto-antibodies (IgG, IgA and IgM)will be measured and comprise ANA (titer and pattern), ENA, anti-dsDNA antibodies, anti-phospholipid antibodies and anti-HMGB1 antibodies. Furthermore, levels of BAFF and APRIL will be determined by luminex. Also, the distribution of B cell subsets by FACS analysis with focus on autoreactive effector memory cells will be assessed. - To investigate the influence of the innate immune system on B cell activation, B cells will be activated in vitro with TLR agonists to investigate ability to produce inflammatory proteins. - To establish IFN type I activation as biomarker of progression to SLE in skin biopsies. At inclusion, in all ILE patients skin biopsies will be taken of unaffected skin and if present of affected skin. Next to IFN type 1 activation, markers for apoptosis and TLR expression will be measured, both at protein and mRNA level. - To investigate the effects of HCQ, all biomarkers mentioned above will be assessed including skin biopsies, before and after 16 weeks of treatment with HCQ, which will be prescribed on clinical grounds.	—

Measure

Time frame

- Other parameters of increased innate immune system activation will be measured including levels of MxA in monocytes and serum, TLR protein expression by FACS and TLR mRNA expression by RT-PCR, and serological biomarkers (a.o. TNF alpha, IL-6 and CXCL-10) will be assessed with luminex - As marker of inflammation and apoptosis, levels of HMGB-1 will be determined. - Production of different auto-antibodies (IgG, IgA and IgM)will be measured and comprise ANA (titer and pattern), ENA, anti-dsDNA antibodies, anti-phospholipid antibodies and anti-HMGB1 antibodies. Furthermore, levels of BAFF and APRIL will be determined by luminex. Also, the distribution of B cell subsets by FACS analysis with focus on autoreactive effector memory cells will be assessed. - To investigate the influence of the innate immune system on B cell activation, B cells will be activated in vitro with TLR agonists to investigate ability to produce inflammatory proteins. - To establish IFN type I activation as biomarker of progression to SLE in skin biopsies. At inclusion, in all ILE patients skin biopsies will be taken of unaffected skin and if present of affected skin. Next to IFN type 1 activation, markers for apoptosis and TLR expression will be measured, both at protein and mRNA level. - To investigate the effects of HCQ, all biomarkers mentioned above will be assessed including skin biopsies, before and after 16 weeks of treatment with HCQ, which will be prescribed on clinical grounds.

—

Countries

Netherlands

Outcome results