Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A and Over|
- - Patients affected by SLE (1982 revised criteria) with scheduled visits to the SLE specialized medical office at Hospital del Mar: - (pain+ / synovitis +): SLE patients with inflammatory pain and synovitis determined by the practitioner during physical examination of radius and ulna carpal joint and/or carpus and/or metacarpophalangeal joint and/or IP .
- - (pain + / synovitis -) SLE patients with inflammatory pain without determined synovitis .
- - (pain - / synovitis -) SLE patients without inflammatory pain with normal physical examination currently or over the past year.
- - Control patients, without SLE nor immediate relatives affected by systemic
inflammatory diseases, who lack articular pain and have blood test with no elevation
APR or autoimmunity +)
Exclusion Criteria:- Jaccoud's arthropaty.
- - RF + and/or ACPA + - Incomplete SLE, MCTD, overlap syndromes.
- - Hand surgery.
- - Current neoplasia.
- - Non-rheumatoid systemic autoimmune diseases.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Hospital del Mar|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|PAtricia corzo, MD|
|Principal Investigator Affiliation||Hospital del Mar|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Hand Rheumatism, Systemic Lupus Erythematosus Arthritis|
BACKGROUND AND RATIONALE.
- - Nowadays no valid classification system for SLE-related arthritis/tenosynovitis exists.
- - Data are not sufficient to establish an SLE-specific pattern of inflammatory involvement, similar to the pattern known for other inflammatory diseases such as rheumatoid arthritis (RA).
- - Erosive arthritis associated with SLE has been typically related to patients that meet the criteria both for SLE and RA - syndrome known as Rhupus; but only a few data exist that classify erosive involvement of articular inflammation of pure SLE.
- - No research exists that links the articular inflammatory pathology associated with SLE with its effect on quality of life (degree of fatigue and HAQ) or with the rest of manifestations and comorbidities associated with SLE.
- - Being able to predict the development of SLE-related arthritis/tenosynovitis would be very useful when it comes to establishing the clinical management, treatment and prognosis of patients with SLE.
- - GENERAL: - To describe the kind of inflammatory articular involvement (synovitis/erosions/bone oedema/tenosynovitis) (6,7) and its frequency in patients affected by pure SLE (excluding Rhupus, mixed connective tissue disease, overlap syndromes).
- - SPECIFIC: - To propose, if possible, an SLE-specific typical pattern of articular involvement.
- - To establish clinical and serological differences (extra-articular manifestations, autoimmunity, treatment received, comorbidities and quality of life) according to the type of inflammatory articular involvement and in comparison to healthy individuals.
- - To evaluate the possible link between SLEDAI/SLICC scores and the involvement using MRI.
- - Patients with SLE have a specific inflammatory articular disease.
- - A SLE-specific pattern of articular involvement exists.
- - There are clinical and serological differences depending on the different patterns of articular involvement in SLE.
Active Comparator: pain+ / synovitis +
SLE patients with inflammatory pain and synovitis determined by the practitioner during physical examination of radius and ulna carpal joint and/or carpus and/or metacarpophalangeal joint and/or IP. Defining synovitis as pain and inflammation and/or deformity (present or existing over the past year) included in the clinical history
Active Comparator: pain + / synovitis -
SLE patients with inflammatory pain without determined synovitis. Current (or over the past year) pain in radius and ulna carpal joint and/or carpus and/or metacarpophalangeal joint and/or IP, with no synovitis
Active Comparator: pain - / synovitis -
SLE patients without inflammatory pain with normal physical examination currently or over the past year
Placebo Comparator: healthy
control patients (healthy participants: no pain, no SLE, no family affected by systemic inflammatory disease, a blood test with no elevation APR or autoimmunity +)
Procedure: - Blood test
Carpus and fingers of non-dominating hand MRI with gadolinium contrast
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.