Systemic Lupus ErythematosusLUMAB2NCT01157468
Catalytic Antibodies and Lupus in Martinique
An observational study of Systemic Lupus Erythematosus, run by University Hospital Center of Martinique at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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:
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Fort de France
Fort de France, Martinique, 97261
About this study
Official title: Study of Catalytic Antibodies in a Cohort Population of Martinique
- 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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus in Martinique, Hydrolase and DNase activities
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Secondary outcomes (1)
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe DELIGNY, MD, Principal investigator, Service de Médecine Interne - Centre Hospitalier Universiatire de Fort de France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157468
- Sponsor's protocol ID
- 10/E/12
- Acronym
- LUMAB2
- Status last verified
- Sep 2016
- First submitted
- 5 Jul 2010
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Catalytic Antibodies in a Cohort Population of Martinique
- ClinicalTrials.gov ID
- NCT01157468
- Acronym / sponsor ID
- LUMAB2 / 10/E/12
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus in Martinique, Hydrolase and DNase activities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (10 listed)
- 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
- Voluntary donor who gave freely his agreement to participate in this study
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of hydrolase and DNase activities
Time frame: 2 years
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)
1 secondary outcome
Association of disease activity and catalytic activity
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe DELIGNY, MD principal investigator
Service de Médecine Interne - Centre Hospitalier Universiatire de Fort de France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by University Hospital Center of Martinique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hydrolase and DNase activities (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.