Lupus and Observance | NCT03019926

Studies
Lupus and Observance

NCT03019926

Sponsor

University Hospital Center of Martinique

Status

Completed

Last Update Posted

Aug 1, 2019Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Systemic Lupus, Skin Lupus

Interventions

Hydroxychloroquine dosage

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2017Actual

Primary Completion Date

Jul 19, 2018Actual

Completion Date

Jul 19, 2018Actual

First Submitted Date

Jan 10, 2017

First Submission Date that Met QC Criteria

Jan 11, 2017

First Posted Date

Jan 13, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2019

Last Update Posted Date

Aug 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis.

New treatment protocols exist and are indicated in second intention in case of good compliance. An assessment of therapeutic adherence is therefore essential.

Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with Plaquenil (hydroxychloroquine), will be included in the study.

The study primary objective is to determine risk factors for non-observance

The secondary objectives are to:

Measure the observance rate of patients with systemic lupus in Martinique.
Describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Name	Type	Description	Arm Group Labels	Other Names
Hydroxychloroquine dosage	Biological	Blood sample from a 6 ml tube, performed in the common practice.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ)	The HCQ dosage is assayed on whole blood (6ml) by high-pressure liquid chromatography performance, reproducible and inexpensive method. Only one laboratory centralizes the sampling. A dosage below 200 ng/ml or 0.2 mg/l defines a non-observing patient within the 40 days above.	Reflects the Plaquenil intake during the 40 previous days

Secondary Outcomes

Measure	Description	Time Frame
Patients considered as observing and non-observing will be compared according to the activity of the disease	Activity of the disease : Systemic lupus considered as active for a SELENA-SLEDAI score ≥ 6	40 days
Patients considered as observing and non-observing will be compared according to number of prescribed medication

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Systemic lupus defined according to the diagnostic criteria of the American College of Rheumatology " 1997, diagnosed for at least 6 months; Or Skin Lupus
Consultation or hospitalization at the University Hospital of Martinique, in either services of Internal Medicine, Rheumatology or Dermatology.
Prescription of hydroxychloroquine (Plaquenil®) for at least 6 months
Affiliate or beneficiary of a social security scheme.
Patient not opposed to participate in the study

Exclusion Criteria:

Age <18 years or patient under guardianship
Patient not speaking and / or not understanding French
No prescription and/or contraindication to hydroxychloroquine
Systemic lupus outbreak with neurological impairment defined by SLEDAI score by a psychosis (disruption of normal activity in relation to a severe alteration of the perception of reality. Includes: hallucinations, incoherence, impoverishment of the content of thought, illogical reasoning, bizarre behavior, disorganized or catatonic) or brain damage (with impairment of mental functions with impaired orientation, memory or other brutal appearance and fluctuating evolution).
History of psychiatric disorders: personality disorders, psychoses, severe depression
Hospitalization with a life-threatening clinical condition that does not allow to answer questions
Non affiliated patient or beneficiary of a social security scheme.
Patient refusing to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study will is proposed to anyone aged 18 years or older with a diagnosis of systemic lupus or skin lupus for at least 6 months, ans who has been prescribed with hydroxychloroquine (Plaquenil) for at least 6 months.

Sampling Method

Non-Probability Sample

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases