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

NCT ID: NCT02364908

Last Updated: 2018-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Systemic Lupus

Group Type OTHER

therapeutic education

Intervention Type OTHER

This is the group sessions aimed to convey additional information to patients about their disease. The main objective is to learn how to better anticipate any medical problems and better manage daily life with the disease.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

therapeutic education

This is the group sessions aimed to convey additional information to patients about their disease. The main objective is to learn how to better anticipate any medical problems and better manage daily life with the disease.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Région Nord-Pas de Calais, France

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric Hachulla, MD, PhD

Role: STUDY_CHAIR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CH Hôpital Duchenne

Boulogne-sur-Mer, , France

Site Status

CH Douai

Douai, , France

Site Status

CH Dunkerque

Dunkirk, , France

Site Status

CH du Dr Schaffner

Lens, , France

Site Status

CHRU, Hôpital Huriez

Lille, , France

Site Status

Victor Provo Hospital

Roubaix, , France

Site Status

Valenciennes hospital

Valenciennes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-A00735-42

Identifier Type: OTHER

Identifier Source: secondary_id

2013_65

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.