Clinical trial NCT04035265: Application of MRI for Musculoskeletal Involvement in SLE
Official title: Application of MRI for Inflammatory Musculoskeletal Involvement in Systemic Lupus Erithematosus (SLE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand Rheumatism
Systemic Lupus Erythematosus Arthritis
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Lupus with synovitis
2. Lupus with joint pain
3. Lupus without synovitis/joint pain
4. Healthy subjects
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

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:

  * 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.

HYPOTHESIS

* 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.

Eligibility criteria: 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 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 -) 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 -) 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
* Contraindication for MRI

Primary outcomes:
measure: MRI inflamatory changes
timeFrame: 1 to 2 months after clinical assesment
measure: SLE activity scale
timeFrame: at clinical assesment
measure: SLE treatments used
timeFrame: at clinical assesment
measure: Fatigue
timeFrame: 2 weeks before the performance of MRI
measure: Quality of life scale
timeFrame: 2 weeks before the performance of MRI
measure: SLE damage scale
timeFrame: at clinical assesment
Secondary outcomes:
measure: Serological markers of disease activity: antinuclear antibodies (ANA)
timeFrame: 6 months prior to 6 months after assesment
measure: Systemic SLE manifestations
timeFrame: at clinical assesment
measure: Hand pain visual analogue scale (VAS)
timeFrame: at clinical assesment
measure: Serological markers of disease activity: Anti-double stranded DNA antibody (DNAds)
timeFrame: 6 months prior to 6 months after assesment (the closest to MRI)
measure: Serological markers of disease activity: Anti-Smith antibodies (Sm)
timeFrame: 6 months prior to 6 months after assesment (the closest to MRI)
measure: Serological markers of disease activity: complement 3 (C3)
timeFrame: 6 months prior to 6 months after assesment (the closest to MRI)
measure: Serological markers of disease activity: complement 4 (C4)
timeFrame: 6 months prior to 6 months after assesment (the closest to MRI)
measure: Serological markers of disease activity: erythrocyte sedimentation rate (ESR)
timeFrame: 6 months prior to 6 months after assesment (the closest to MRI)
measure: Serological markers of disease activity: C reactive protein (CRP)
timeFrame: 6 months prior to 6 months after assesment (the closest to MRI)
measure: Serological markers of disease activity:white cell blood count (WCBC)
timeFrame: 6 months prior to 6 months after assesment (the closest to MRI)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Hospital del Mar
name: PAtricia corzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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. Erratum In: Skeletal Radiol. 2015 Feb;44(2):267. doi: 10.1007/s00256-014-2054-8.. Chiara, Tani [corrected to Tani, Chiara]; Dario, D'aniello [corrected to D'Aniello, Dario]; Niccolo, Possemato [corrected to Possemato, Niccolo]; Andrea, Delle Sedie [corrected to Delle Sedie, Andrea]; Davide, Caramella [corrected to Caramella, Davide].
citation: 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.
citation: 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.
citation: 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.