Catalytic Antibodies and Lupus in Martinique | NCT01157468

Studies
Catalytic Antibodies and Lupus in Martinique

NCT01157468

Sponsor

University Hospital Center of Martinique

Status

Completed

Last Update Posted

Sep 8, 2016Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Systemic Lupus Erythematosus

Interventions

Not provided

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

Sep 2016

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 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 5, 2010

First Submission Date that Met QC Criteria

Jul 6, 2010

First Posted Date

Jul 7, 2010Estimated

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

Sep 7, 2016

Last Update Posted Date

Sep 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The Martinique island (French West-Indies) is an area of high prevalence and incidence for Systemic Lupus Erythematosus (SLE), respectively 64,2/ 100000 and 4,7/ 100000. In many cases, this disease concerns Afro Caribbean women, whose auto-antibodies are excessively high; also, organic damages are frequent. The disease can be fatal.
Studies have shown that some cytotoxic auto-antibodies may have a responsibility in the hydrolysing of DNA. This study will focus on the DNA activity and also on the overwhelm hydrolase activity dealing with the Lupus disease in order to measure the link between the disease activity and the catalytic activity. Patients concerned by this study will be Martinique people.

Detailed Description

This study will be conducted as an case-control survey.

The first group with patients: 60 SLE patients, 30 patients with a quiescent lupus and 30 patients with an active lupus. Patients that will be included are followed by the University hospital of Fort-de-France.
The second group is the control group: subjects will be recruited by the French organisation responsible for donation of blood.

Test will be done at the UMRS 872 laboratory of the INSERM - Laboratory of Immunopathology and Therapeutic immunointervention - in Paris ; two catalytic activities will be tested: the DNase activity and the hydrolase activity.

Means to analyse the two activities: digestion of plasmid and Affinity-linked Oligonucleotide Nuclease Assay for DNase activity and hydrolysis of a peptide PFR-MCA for hydrolase activity.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cases		The "Case" group is constituted with patients with Systemic Lupus Erythematosus from Martinique, divided en 2: 30 patients with a quiescent lupus 30 patients with an active lupus
Controles		The "Control" group is constituted by people coming to give blood to the French Blood Establishment of Martinique.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of hydrolase and DNase activities	Estimate the presence of a significant enzymatic activity by calculating the frequency of the hydrolase and DNase activities in lupus in Martinique(French west-indies)	2 years

Secondary Outcomes

Measure	Description	Time Frame
Association of disease activity and catalytic activity	Evaluate the strength of the association of disease activity and catalytic activity of antibodies (quiescent / active and control / patient)	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For patients:

Presence of systemic lupus erythematosus according to the criteria of the modified 1997 ARA 1982 Lupus systemic evolution: Rates of anti DNA> 100 U/L in ELISA and SLEDAI> 7. Quiescent systemic Lupus: SLEDAI <7
Be aged 18 years and over
Patient who has his main home in Martinique
Patient who gave his agreement to participate in this clinical study

For control subjects:

Voluntary donor who gave freely his agreement to participate in this study
Be aged 18 years and over
Patient who has his main home in Martinique
Voluntary who gave his agreement to participate in this clinical study

Exclusion Criteria:

For patients:

Presence of mixed connective tissue disease, Hashimoto
Patients with other diseases: cancer, current infection
Patient pregnant or breast-feeding
Patient who refuse to participate in the study
Patient not affiliated with a social security scheme (beneficiary or beneficiary)
Specially Protected Persons (or under guardianship)
Patient who has not his main home in Martinique

For control subjects:

Voluntary donor who refused to participate in this study
Voluntary who has not main home in Martinique

Accepts Healthy Volunteers

Yes

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

Cases are patients with Systemic Lupus Erythematosus treated at the Centre Hospitalier of Fort de France (Martinique): patients with a quiescent lupus and patients with an active lupus.

Controles are people coming to donate blood samples at the French Blood Establishment of Martinique.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Christophe DELIGNY, MD	Service de Médecine Interne - Centre Hospitalier Universiatire de Fort de France	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Fort de France		Fort de France	Martinique	97261	France

ID	Term
D008180	Lupus Erythematosus, Systemic

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

Description

For the "case" means the research will be done on a blood sample of 7 ml, reclassified from treatement to research, collected from the blood sampling usually prescribed by doctors to treat the patient come to be diagnosed a lupus or for continuing care.
For the "control" means research will be done on a blood sample of 7 ml collected from people coming to donate blood at thethe French Blood Establishment of Martinique.

The volume does not exceed the maximum amount allowed by French regulations for blood donation.