Systemic Lupus, Skin LupusLUPOBSNCT03019926
Lupus and Observance
An observational study of Systemic Lupus, Skin Lupus, run by University Hospital Center of Martinique at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus, Skin Lupus
- What is being tested?
- Hydroxychloroquine dosage
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2017to 19 Jul 2018
- 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
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Systemic Lupus, Skin Lupus
- Being tested
- Hydroxychloroquine dosage
- Keywords
- systemic lupus erythematosus, observance, hydroxychloroquine dosage, risk factors of non-observance, SLICC score, SLEDAI score
- 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.
Hydroxychloroquine dosageBiological
Blood sample from a 6 ml tube, performed in the common practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Reflects the Plaquenil intake during the 40 previous days
Secondary outcomes (3)
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
Measured: 40 days
Patients considered as observing and non-observing will be compared according to number of prescribed medication
Measured: 40 days
Patients considered as observing and non-observing will be compared according to the presence of anxiety and/or depressive disorders
Presence of anxiety and/or depressive disorders, according to the Hospital Anxiety And Depression Scale (HAD), a score > to 10
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start19 Jan 2017
- Primary completion19 Jul 2018
- Study completion19 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus, Skin LupusStudies 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
- Cohort
- 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
- Katlyne POLOMAT, MD, Principal investigator, CHU of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019926
- Sponsor's protocol ID
- 16/B/09
- Acronym
- LUPOBS
- Status last verified
- Jun 2018
- First submitted
- 10 Jan 2017
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lupus and Observance
- ClinicalTrials.gov ID
- NCT03019926
- Acronym / sponsor ID
- LUPOBS / 16/B/09
- Conditions
- Systemic Lupus, Skin Lupus
- Keywords
- systemic lupus erythematosus, observance, hydroxychloroquine dosage, risk factors of non-observance, SLICC score, SLEDAI score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 13 Jan 2017 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine dosageBlood sample from a 6 ml tube, performed in the common practice. | Biological | – |
Primary outcome
The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ)
Time frame: Reflects the Plaquenil intake during the 40 previous days
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.
3 secondary outcomes
Patients considered as observing and non-observing will be compared according to the activity of the disease
Time frame: 40 days
Patients considered as observing and non-observing will be compared according to number of prescribed medication
Time frame: 40 days
Patients considered as observing and non-observing will be compared according to the presence of anxiety and/or depressive disorders
Time frame: 40 days
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 1 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Katlyne POLOMAT, MD principal investigator
CHU of Martinique
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, Skin Lupus, 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 6 inclusion and 8 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 1 Aug 2019. 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?
The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ) (time frame: Reflects the Plaquenil intake during the 40 previous days). 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 1 Aug 2019.