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PRediction Of Flares In Lupus With autoantibodiEs and Chemokines

NCT04951427 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-05-24

No results posted yet for this study

Summary

Rationale: Systemic lupus erythematosus (SLE) is a chronic relapsing-remitting autoimmune disease with a wide range of clinical manifestations affecting several organs. Although the management of lupus patients has improved in the last years, accurate models for predicting disease progression are lacking.

Objective: To prospectively evaluate the predictive value of a combination of chemokines, MMPs/TIMPs, and autoantibody levels for predicting flares in patients with SLE Study design: prospective, observational single centre cohort study, conducted at the department of Rheumatology and Clinical Immunology of the UMC Utrecht Study population: Adult patients with SLE (according to EULAR/ACR criteria) under control in the UMC Utrecht.

Intervention (if applicable): n/a

Main study parameters/endpoints:

* Profile of autoantibodies and chemokines in visits previous to recorded flares, compared to visits previous to no recorded flares. Risk calculations will be made using areas under the curve (AUC) for both individual markers as multivariate analysis
* Changes in the profile of autoantibodies and chemokines in patients with lower reported quality of life measured by LupusQoL questionnaire, compared to previous visits of the same patient.
* Changes in titer levels of autoantibodies before and after start of biological treatment.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: this is an observational study; the burden for patients is esteemed to be low. For some patients who regularly attend the outpatient clinic yearly, the four-times a year visits during two years will be more frequent, including more frequent blood sampling, compared to standard care. Furthermore, more blood will be drawn per sampling, compared to standard care.

Conditions

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Maarten Limper, MD PhD · UMC Utrecht

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2023-08-01
Completion
2024-08-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04951427 on ClinicalTrials.gov