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Articular involvement can reach up to 95% within the chronic multisystemic manifestations of SLE (1). Originally, a non-erosive pattern of articular inflammation was described, but the emergence of more sensitive imaging techniques, such as MRI (2, 3), show synovitis, erosions (hand: 47-48%, carpus 82-84% in SLE; and hand: 18%, carpus 97% in healthy individuals), bone oedema (hand: 4-5%, carpus 13-16% in SLE; and 0% in healthy individuals) and tenosynovitis (hand 47%, carpus 79%; not evaluated in healthy individuals) in patients with SLE (4, 5). Nowadays, a specific validated pattern of articular involvement associated with this disease does not yet exist, although it has begun to be studied. This research tries to evaluate the presence, frequency and distribution of inflammatory articular manifestations in SLE (erosions, bone oedema, synovitis or tenosynovitis) using MRI (6), with the objective of trying to establish a specific pattern for this disease, if it exists, that can shorten the diagnostic process. Moreover, it tries to characterise, if they exist, clinical differences between various patient groups according to their articular involvement.
BACKGROUND AND RATIONALE
OBJECTIVES
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:
HYPOTHESIS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pain+ / synovitis + | Active Comparator | 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 |
|
| pain + / synovitis - | Active Comparator | 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 |
|
| pain - / synovitis - | Active Comparator | SLE patients without inflammatory pain with normal physical examination currently or over the past year |
|
| healthy | Placebo Comparator | control patients (healthy participants: no pain, no SLE, no family affected by systemic inflammatory disease, a blood test with no elevation APR or autoimmunity +) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Procedure | Carpus and fingers of non-dominating hand MRI with gadolinium contrast |
|
| Measure | Description | Time Frame |
|---|---|---|
| MRI inflamatory changes | synovitis, erosions, bone oedema, tenosynovitis | 1 to 2 months after clinical assesment |
| SLE activity scale | Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Measures last 10 days disease activity (rating (Y/N) 24 items related to specific manifestations on 9 organs) From 0 (best) to 105 (worst) | at clinical assesment |
| SLE treatments used | Number (n and %) of participants using any approved treatments for SLE used since diagnosis | at clinical assesment |
| Fatigue | Fatigue Severity Scale (FSS-9) Results from 9 (best) to 63 (worst): rating 9 items ranging from 1(best) to 7 (worst) | 2 weeks before the performance of MRI |
| Quality of life scale | modified health assessment questionnaire (MHAQ): Results from 0 (best) to 3 (worst): rating 9 items from 0 (best) to 3 (worst) (results given divided by 8) | 2 weeks before the performance of MRI |
| SLE damage scale | Systemic Lupus International Collaborating Clinics (SLICC) damage index: Irreversible damage rated by: 42 items related to 12 organs: 0 (absent-best)/1 (present-worst), some of them can count 2 or 3 (worst) if recidivant. From 0 (best) to 46 (worst) | at clinical assesment |
| Measure | Description | Time Frame |
|---|---|---|
| Serological markers of disease activity: antinuclear antibodies (ANA) | ANA (dilution): given by titters (average titters comapred between groups) | 6 months prior to 6 months after assesment |
| Systemic SLE manifestations |
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Inclusion Criteria:
Patients affected by SLE (1982 revised criteria) with scheduled visits to the SLE specialized medical office at Hospital del Mar:
(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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Corzo, MD | Contact | +34655057358 | pcorzoreumatologia@gmail.com | |
| Tarek Carlos Salman, PhD | Contact | tareto4@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| PAtricia corzo, MD | Hospital del Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar | Recruiting | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22179731 | Background | Ball EM, Bell AL. Lupus arthritis--do we have a clinically useful classification? Rheumatology (Oxford). 2012 May;51(5):771-9. doi: 10.1093/rheumatology/ker381. Epub 2011 Dec 15. | |
| 25183245 | Background | Mosca M, Tani C, Carli L, Vagnani S, Possemato N, Delle Sedie A, Cagnoni M, D'Aniello D, Riente L, Caramella D, Bombardieri S. The role of imaging in the evaluation of joint involvement in 102 consecutive patients with systemic lupus erythematosus. Autoimmun Rev. 2015 Jan;14(1):10-5. doi: 10.1016/j.autrev.2014.08.007. Epub 2014 Aug 23. |
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IPD will be used for PhD investigations. IPD will not be shared with other researchers
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 28, 2022 | |
| Reset | Jun 29, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 28, 2022 | Jun 29, 2023 |
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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|
presence of renal, lung, skin, neurological, haematological manifestations since diagnostic (Yes/No)
| at clinical assesment |
| Hand pain visual analogue scale (VAS) | VAS 0 (none) to 10 (maximum) | at clinical assesment |
| Serological markers of disease activity: Anti-double stranded DNA antibody (DNAds) | Titters DNAds (UI/ml) | 6 months prior to 6 months after assesment (the closest to MRI) |
| Serological markers of disease activity: Anti-Smith antibodies (Sm) | Presence of Sm (Yes/No) | 6 months prior to 6 months after assesment (the closest to MRI) |
| Serological markers of disease activity: complement 3 (C3) | titters C3 (mg/dL) | 6 months prior to 6 months after assesment (the closest to MRI) |
| Serological markers of disease activity: complement 4 (C4) | titters C4 (mg/dl) | 6 months prior to 6 months after assesment (the closest to MRI) |
| Serological markers of disease activity: erythrocyte sedimentation rate (ESR) | ESR (mm/h) | 6 months prior to 6 months after assesment (the closest to MRI) |
| Serological markers of disease activity: C reactive protein (CRP) | CRP (mg/dl) | 6 months prior to 6 months after assesment (the closest to MRI) |
| Serological markers of disease activity:white cell blood count (WCBC) | WCBC: cellsx10E9/L | 6 months prior to 6 months after assesment (the closest to MRI) |
| 25341505 | Background | Tani C, D'Aniello D, Possemato N, Delle Sedie A, Caramella D, Bombardieri S, Mosca M. MRI pattern of arthritis in systemic lupus erythematosus: a comparative study with rheumatoid arthritis and healthy subjects. Skeletal Radiol. 2015 Feb;44(2):261-6. doi: 10.1007/s00256-014-2033-0. Epub 2014 Oct 24. |
| 15972342 | Background | Boutry N, Hachulla E, Flipo RM, Cortet B, Cotten A. MR imaging findings in hands in early rheumatoid arthritis: comparison with those in systemic lupus erythematosus and primary Sjogren syndrome. Radiology. 2005 Aug;236(2):593-600. doi: 10.1148/radiol.2361040844. Epub 2005 Jun 21. |
| 12784422 | Background | Ostergaard M, Peterfy C, Conaghan P, McQueen F, Bird P, Ejbjerg B, Shnier R, O'Connor P, Klarlund M, Emery P, Genant H, Lassere M, Edmonds J. OMERACT Rheumatoid Arthritis Magnetic Resonance Imaging Studies. Core set of MRI acquisitions, joint pathology definitions, and the OMERACT RA-MRI scoring system. J Rheumatol. 2003 Jun;30(6):1385-6. |
| 17392347 | Background | Haavardsholm EA, Ostergaard M, Ejbjerg BJ, Kvan NP, Kvien TK. Introduction of a novel magnetic resonance imaging tenosynovitis score for rheumatoid arthritis: reliability in a multireader longitudinal study. Ann Rheum Dis. 2007 Sep;66(9):1216-20. doi: 10.1136/ard.2006.068361. Epub 2007 Mar 28. |