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Status unknownNCT04035265RMNLESUpdated Jul 31, 2019

Application of MRI for Musculoskeletal Involvement in SLE

An interventional study of Blood test in Hand Rheumatism and Systemic Lupus Erythematosus Arthritis, sponsored by Hospital del Mar. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2019-07-31.

Sponsored by Hospital del Mar · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2018, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hand Rheumatism
  • Systemic Lupus Erythematosus Arthritis
03

In context

Rheumatic Diseases

377 studies on the registry are indexed under Rheumatic Diseases; 79 are open to participants now.

This study's planned enrollment of 120 is above the median of 74 across 210 interventional studies indexed under Rheumatic Diseases.

Browse Rheumatic Diseases studies →

Lead sponsor

Hospital del Mar is the lead sponsor of 45 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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

    Procedure: Blood test

  • 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

    Procedure: Blood test

  • Active comparator
    pain - / synovitis -

    SLE patients without inflammatory pain with normal physical examination currently or over the past year

    Procedure: Blood test

  • 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

Interventions

  • ProcedureBlood test

    Carpus and fingers of non-dominating hand MRI with gadolinium contrast

    Also known as: hand MRI

06

What researchers measure

Primary outcomes

  1. MRI inflamatory changes

    synovitis, erosions, bone oedema, tenosynovitis

    Time frame: 1 to 2 months after clinical assesment

  2. 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)

    Time frame: at clinical assesment

  3. SLE treatments used

    Number (n and %) of participants using any approved treatments for SLE used since diagnosis

    Time frame: at clinical assesment

  4. Fatigue

    Fatigue Severity Scale (FSS-9) Results from 9 (best) to 63 (worst): rating 9 items ranging from 1(best) to 7 (worst)

    Time frame: 2 weeks before the performance of MRI

  5. 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)

    Time frame: 2 weeks before the performance of MRI

  6. 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)

    Time frame: at clinical assesment

Secondary outcomes

  1. Serological markers of disease activity: antinuclear antibodies (ANA)

    ANA (dilution): given by titters (average titters comapred between groups)

    Time frame: 6 months prior to 6 months after assesment

  2. Systemic SLE manifestations

    presence of renal, lung, skin, neurological, haematological manifestations since diagnostic (Yes/No)

    Time frame: at clinical assesment

  3. Hand pain visual analogue scale (VAS)

    VAS 0 (none) to 10 (maximum)

    Time frame: at clinical assesment

  4. Serological markers of disease activity: Anti-double stranded DNA antibody (DNAds)

    Titters DNAds (UI/ml)

    Time frame: 6 months prior to 6 months after assesment (the closest to MRI)

  5. Serological markers of disease activity: Anti-Smith antibodies (Sm)

    Presence of Sm (Yes/No)

    Time frame: 6 months prior to 6 months after assesment (the closest to MRI)

  6. Serological markers of disease activity: complement 3 (C3)

    titters C3 (mg/dL)

    Time frame: 6 months prior to 6 months after assesment (the closest to MRI)

  7. Serological markers of disease activity: complement 4 (C4)

    titters C4 (mg/dl)

    Time frame: 6 months prior to 6 months after assesment (the closest to MRI)

  8. Serological markers of disease activity: erythrocyte sedimentation rate (ESR)

    ESR (mm/h)

    Time frame: 6 months prior to 6 months after assesment (the closest to MRI)

  9. Serological markers of disease activity: C reactive protein (CRP)

    CRP (mg/dl)

    Time frame: 6 months prior to 6 months after assesment (the closest to MRI)

  10. Serological markers of disease activity:white cell blood count (WCBC)

    WCBC: cellsx10E9/L

    Time frame: 6 months prior to 6 months after assesment (the closest to MRI)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 22179731 ↗
  • 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. PubMed 25183245 ↗
  • 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]. PubMed 25341505 ↗
  • 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. PubMed 15972342 ↗
  • 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. Erratum In: J Rheumatol. 2004 Jan;31(1):198. PubMed 12784422 ↗
  • 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. PubMed 17392347 ↗

Individual participant data

Plan to share: No — IPD will be used for PhD investigations. IPD will not be shared with other researchers

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04035265
Lead sponsor
Hospital del Mar
Responsible party
Patricia Corzo (M.D. Rheumatologist consultant, Hospital del Mar) — Principal investigator
First posted
Jul 29, 2019
Start date
Dec 1, 2018
Primary completion
Jan 2020 (estimated)
Completion
May 2020 (estimated)
Last update
Jul 31, 2019

Study contacts

Patricia Corzo, MD
Contact
pcorzoreumatologia@gmail.com
+34655057358
Tarek Carlos Salman, PhD
Contact
tareto4@gmail.com
PAtricia corzo, MD
principal investigator · Hospital del Mar

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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