Application of MRI for Musculoskeletal Involvement in SLE

Not Applicable

• Conditions: Hand Rheumatism; Systemic Lupus Erythematosus Arthritis
• Interventions: Procedure: Blood test

• Registration Number: NCT04035265
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-29
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31
• Primary Completion: 2020-01
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 +)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pain + / synovitis -	Blood test	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
healthy	Blood test	control patients (healthy participants: no pain, no SLE, no family affected by systemic inflammatory disease, a blood test with no elevation APR or autoimmunity +)
pain+ / synovitis +	Blood test	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 -	Blood test	SLE patients without inflammatory pain with normal physical examination currently or over the past year

Primary Outcome Measures

Name	Time	Method
MRI inflamatory changes	1 to 2 months after clinical assesment	synovitis, erosions, bone oedema, tenosynovitis
Fatigue	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)
SLE activity scale	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)
SLE damage scale	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)
Quality of life scale	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)
SLE treatments used	at clinical assesment	Number (n and %) of participants using any approved treatments for SLE used since diagnosis

Secondary Outcome Measures

Name	Time	Method
Serological markers of disease activity: Anti-double stranded DNA antibody (DNAds)	6 months prior to 6 months after assesment (the closest to MRI)	Titters DNAds (UI/ml)
Serological markers of disease activity: Anti-Smith antibodies (Sm)	6 months prior to 6 months after assesment (the closest to MRI)	Presence of Sm (Yes/No)
Serological markers of disease activity: complement 4 (C4)	6 months prior to 6 months after assesment (the closest to MRI)	titters C4 (mg/dl)
Serological markers of disease activity: antinuclear antibodies (ANA)	6 months prior to 6 months after assesment	ANA (dilution): given by titters (average titters comapred between groups)
Hand pain visual analogue scale (VAS)	at clinical assesment	VAS 0 (none) to 10 (maximum)
Serological markers of disease activity: complement 3 (C3)	6 months prior to 6 months after assesment (the closest to MRI)	titters C3 (mg/dL)
Serological markers of disease activity:white cell blood count (WCBC)	6 months prior to 6 months after assesment (the closest to MRI)	WCBC: cellsx10E9/L
Systemic SLE manifestations	at clinical assesment	presence of renal, lung, skin, neurological, haematological manifestations since diagnostic (Yes/No)
Serological markers of disease activity: erythrocyte sedimentation rate (ESR)	6 months prior to 6 months after assesment (the closest to MRI)	ESR (mm/h)
Serological markers of disease activity: C reactive protein (CRP)	6 months prior to 6 months after assesment (the closest to MRI)	CRP (mg/dl)

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain