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Application of MRI for Musculoskeletal Involvement in SLE (RMNLES)

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ClinicalTrials.gov Identifier: NCT04035265
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Patricia Corzo, Hospital del Mar

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.

Condition or disease Intervention/treatment Phase
Hand Rheumatism Systemic Lupus Erythematosus Arthritis Procedure: Blood test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Lupus with synovitis
  2. Lupus with joint pain
  3. Lupus without synovitis/joint pain
  4. Healthy subjects
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Application of MRI for Inflammatory Musculoskeletal Involvement in Systemic Lupus Erithematosus (SLE)
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
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
Carpus and fingers of non-dominating hand MRI with gadolinium contrast
Other Name: hand MRI

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

Active Comparator: pain - / synovitis -
SLE patients without inflammatory pain with normal physical examination currently or over the past year
Procedure: Blood test
Carpus and fingers of non-dominating hand MRI with gadolinium contrast
Other Name: hand MRI

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
Other Name: hand MRI




Primary Outcome Measures :
  1. MRI inflamatory changes [ Time Frame: 1 to 2 months after clinical assesment ]
    synovitis, erosions, bone oedema, tenosynovitis

  2. SLE activity scale [ Time Frame: at clinical assesment ]
    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)

  3. SLE treatments used [ Time Frame: at clinical assesment ]
    Number (n and %) of participants using any approved treatments for SLE used since diagnosis

  4. Fatigue [ Time Frame: 2 weeks before the performance of MRI ]
    Fatigue Severity Scale (FSS-9) Results from 9 (best) to 63 (worst): rating 9 items ranging from 1(best) to 7 (worst)

  5. Quality of life scale [ Time Frame: 2 weeks before the performance of MRI ]
    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)

  6. SLE damage scale [ Time Frame: at clinical assesment ]

    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)



Secondary Outcome Measures :
  1. Serological markers of disease activity: antinuclear antibodies (ANA) [ Time Frame: 6 months prior to 6 months after assesment ]
    ANA (dilution): given by titters (average titters comapred between groups)

  2. Systemic SLE manifestations [ Time Frame: at clinical assesment ]
    presence of renal, lung, skin, neurological, haematological manifestations since diagnostic (Yes/No)

  3. Hand pain visual analogue scale (VAS) [ Time Frame: at clinical assesment ]
    VAS 0 (none) to 10 (maximum)

  4. Serological markers of disease activity: Anti-double stranded DNA antibody (DNAds) [ Time Frame: 6 months prior to 6 months after assesment (the closest to MRI) ]
    Titters DNAds (UI/ml)

  5. Serological markers of disease activity: Anti-Smith antibodies (Sm) [ Time Frame: 6 months prior to 6 months after assesment (the closest to MRI) ]
    Presence of Sm (Yes/No)

  6. Serological markers of disease activity: complement 3 (C3) [ Time Frame: 6 months prior to 6 months after assesment (the closest to MRI) ]
    titters C3 (mg/dL)

  7. Serological markers of disease activity: complement 4 (C4) [ Time Frame: 6 months prior to 6 months after assesment (the closest to MRI) ]
    titters C4 (mg/dl)

  8. Serological markers of disease activity: erythrocyte sedimentation rate (ESR) [ Time Frame: 6 months prior to 6 months after assesment (the closest to MRI) ]
    ESR (mm/h)

  9. Serological markers of disease activity: C reactive protein (CRP) [ Time Frame: 6 months prior to 6 months after assesment (the closest to MRI) ]
    CRP (mg/dl)

  10. Serological markers of disease activity:white cell blood count (WCBC) [ Time Frame: 6 months prior to 6 months after assesment (the closest to MRI) ]
    WCBC: cellsx10E9/L



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035265


Contacts
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Contact: Patricia Corzo, MD +34655057358 pcorzoreumatologia@gmail.com
Contact: Tarek Carlos Salman, PhD tareto4@gmail.com

Locations
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Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: PAtricia Corzo Salman, MD    +34655057358    pcorzoreumatologia@gmail.com   
Sponsors and Collaborators
Hospital del Mar
Investigators
Layout table for investigator information
Principal Investigator: PAtricia corzo, MD Hospital del Mar

Publications:

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Responsible Party: Patricia Corzo, M.D. Rheumatologist consultant, Hospital del Mar
ClinicalTrials.gov Identifier: NCT04035265    
Other Study ID Numbers: RMNLES
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be used for PhD investigations. IPD will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Diseases
Lupus Erythematosus, Systemic
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases