Diagnosis of Lupus According to ACR criteriaAgreement for the Blood SamplingNCT01889641
IL-26 and Systemic Lupus Erythematosus
An observational study of Diagnosis of Lupus According to ACR criteriaAgreement for the Blood Sampling, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Treatment of multisystemic forms of lupus displays severe side effects and limited efficacy, underscoring the need to better dissection of the pathogenic mechanisms. Concordant with preliminary data, IL26 signaling could be impaired in systemic lupus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnosis of Lupus According to ACR criteriaAgreement for the Blood Sampling
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Apr 2015
- 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: patient and healthy volunteers
Who may be able to join
- diagnostic of Lupus according to ACR criteria ( four criteria are necessary)
- age > 18 years old
Who cannot join
- treatment by cyclophosphamide, rituximab, belimumab in the year before inclusion study
Trial locations and contacts
1 site in 1 country.
France1 site
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas Rhin, 67091
About this study
Official title: Intérêt de l'IL-26 Comme Nouveau Marqueur Biologique du Lupus érythémateux systémique
Treatment of multisystemic forms of lupus displays severe side effects and limited efficacy, underscoring the need to better dissection of the pathogenic mechanisms. Concordant with preliminary data, IL26 signaling could be impaired in systemic lupus. Moreover, IL 26 could be a marker of the disease activity and then a potential therapeutic target. In the present study, serum IL 26 level in lupus patients and control will be measured.
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 |
|---|---|---|
| Patients with lupus | Patients with lupus (four levels of activity disease) | |
| healthy volunteers | Subjects controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess serum IL-26 as a biological marker of SLE compared with sera from control subjects
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 posted28 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis of Lupus According to ACR criteriaAgreement for the Blood SamplingStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889641
- Sponsor's protocol ID
- 5504
- Status last verified
- Sep 2017
- First submitted
- 25 Jun 2013
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intérêt de l'IL-26 Comme Nouveau Marqueur Biologique du Lupus érythémateux systémique
- ClinicalTrials.gov ID
- NCT01889641
- Acronym / sponsor ID
- 5504
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Jun 2013 (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.
Treatment of multisystemic forms of lupus displays severe side effects and limited efficacy, underscoring the need to better dissection of the pathogenic mechanisms. Concordant with preliminary data, IL26 signaling could be impaired in systemic lupus. Moreover, IL 26 could be a marker of the disease activity and then a potential therapeutic target. In the present study, serum IL 26 level in lupus patients and control will be measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with lupus | – | –Patients with lupus (four levels of activity disease) |
| healthy volunteers | – | –Subjects controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patient and healthy volunteers
Key inclusion criteria (2 listed)
- diagnostic of Lupus according to ACR criteria ( four criteria are necessary)
- age > 18 years old
Key exclusion criteria (1 listed)
- treatment by cyclophosphamide, rituximab, belimumab in the year before inclusion study
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
Assess serum IL-26 as a biological marker of SLE compared with sera from control subjects
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diagnosis of Lupus According to ACR criteriaAgreement for the Blood Sampling, run by University Hospital, Strasbourg, France 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 Sep 2017. 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 was stopped early. Results are not available in the source record.
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?
Assess serum IL-26 as a biological marker of SLE compared with sera from control subjects (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 2017.