Prospective Evaluation of Decision and Compliance With Antimalarials in Patients With Systemic Lupus (ESSTIM)

University Hospital, Lille

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Other: therapeutic education

Study type: Interventional

Funder types: Other

Identifiers

NCT02364908

2013_65

2014-A00735-42 (Other Identifier)

Details and patient eligibility

About

This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...).

The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with a systemic lupus with ACR criteria (at least 4 criterias)
• patients with antimalarials for at least 3 months with a minimum dose of 200 mg/day.

Exclusion criteria

• patients who refuse to sign the informed consent
• patients who are under guardianship

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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158 participants in 1 patient group

Patients with Systemic Lupus

Other group

Treatment:

Other: therapeutic education