Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 20 March 2023
• Main ID: NCT03575156
• Date of registration: 07/06/2018
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Bordeaux
• Public title: Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis MICROLUPS
• Scientific title: Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis
• Date of first enrolment: September 20, 2018
• Target sample size: 208
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03575156
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Christophe RICHEZ, Prof
• Affiliation: CHU Bordeaux

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosis of systemic lupus erythematosus or systemic sclerosis;

- age = 18 years;

- being affiliated to health insurance, willing to participate and to sign informed
consent.

Exclusion Criteria:

- pregnant or breastfeeding women;

- patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty
by a judicial or administrative decision, minors, persons of legal age who are the
object of a legal protection measure or unable to express their consent)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Systemic Scleroderma

Intervention(s)

Biological: urine sample

Biological: blood sample

Primary Outcome(s)

Change in quantitative levels of circulating MPs between baseline and 12 months in the blood and urine samples of SLE and SSc patients [Time Frame: At baseline (Day 0) and 12 months from baseline]

Secondary Outcome(s)

Disease activity scores for SSc patients [Time Frame: At baseline (Day 0) and 12 months from baseline]

Quantification of FAS-ligand levels in the blood and urine samples of SLE and SSc [Time Frame: At baseline (Day 0) and 12 months from baseline]

Quantification of P-selectin levels (soluble and on platelets) in the blood and urine samples of SLE and SSc patients [Time Frame: At baseline (Day 0) and 12 months from baseline]

Disease activity scores for SLE patients [Time Frame: At baseline (Day 0) and 12 months from baseline]

Secondary ID(s)

CHUBX 2017/54

Source(s) of Monetary Support

Please refer to primary and secondary sponsors