Application of MRI for Musculoskeletal Involvement in SLE

Application of MRI for Inflammatory Musculoskeletal Involvement in Systemic Lupus Erithematosus (SLE)

Sponsors

Lead Sponsor: Hospital del Mar

Source 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.

Overall Status Recruiting
Start Date December 1, 2018
Completion Date May 2020
Primary Completion Date January 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
MRI inflamatory changes 1 to 2 months after clinical assesment
SLE activity scale at clinical assesment
SLE treatments used at clinical assesment
Fatigue 2 weeks before the performance of MRI
Quality of life scale 2 weeks before the performance of MRI
SLE damage scale at clinical assesment
Secondary Outcome
Measure Time Frame
Serological markers of disease activity: antinuclear antibodies (ANA) 6 months prior to 6 months after assesment
Systemic SLE manifestations at clinical assesment
Hand pain visual analogue scale (VAS) at clinical assesment
Serological markers of disease activity: Anti-double stranded DNA antibody (DNAds) 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: Anti-Smith antibodies (Sm) 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: complement 3 (C3) 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: complement 4 (C4) 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: erythrocyte sedimentation rate (ESR) 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity: C reactive protein (CRP) 6 months prior to 6 months after assesment (the closest to MRI)
Serological markers of disease activity:white cell blood count (WCBC) 6 months prior to 6 months after assesment (the closest to MRI)
Enrollment 120
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Blood test

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

Other Name: hand MRI

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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
PAtricia corzo, MD Principal Investigator Hospital del Mar
Overall Contact

Last Name: Patricia Corzo, MD

Phone: +34655057358

Email: [email protected]

Location
Facility: Status: Contact: Hospital del Mar PAtricia Corzo Salman, MD +34655057358 [email protected]
Location Countries

Spain

Verification Date

July 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hospital del Mar

Investigator Full Name: Patricia Corzo

Investigator Title: M.D. Rheumatologist consultant

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: pain+ / synovitis +

Type: Active Comparator

Description: 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

Label: pain + / synovitis -

Type: Active Comparator

Description: 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

Label: pain - / synovitis -

Type: Active Comparator

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

Label: healthy

Type: Placebo Comparator

Description: control patients (healthy participants: no pain, no SLE, no family affected by systemic inflammatory disease, a blood test with no elevation APR or autoimmunity +)

Acronym RMNLES
Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Lupus with synovitis Lupus with joint pain Lupus without synovitis/joint pain Healthy subjects

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov