Application of MRI for Inflammatory Musculoskeletal Involvement in Systemic Lupus Erithematosus (SLE)
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- MRI inflamatory changes
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 +)
排除标准
- •Jaccoud's arthropaty
- •RF + and/or ACPA +
- •Incomplete SLE, MCTD, overlap syndromes
- •Hand surgery
- •Current neoplasia
- •Non-rheumatoid systemic autoimmune diseases
- •Contraindication for MRI
研究组 & 干预措施
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
干预措施: Blood test (Procedure)
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
干预措施: Blood test (Procedure)
pain - / synovitis -
SLE patients without inflammatory pain with normal physical examination currently or over the past year
干预措施: Blood test (Procedure)
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 +)
干预措施: Blood test (Procedure)
结局指标
主要结局
MRI inflamatory changes
时间窗: 1 to 2 months after clinical assesment
synovitis, erosions, bone oedema, tenosynovitis
Fatigue
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: at clinical assesment
Number (n and %) of participants using any approved treatments for SLE used since diagnosis
次要结局
- 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 4 (C4)(6 months prior to 6 months after assesment (the closest to MRI))
- Serological markers of disease activity: antinuclear antibodies (ANA)(6 months prior to 6 months after assesment)
- Hand pain visual analogue scale (VAS)(at clinical assesment)
- 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:white cell blood count (WCBC)(6 months prior to 6 months after assesment (the closest to MRI))
- Systemic SLE manifestations(at clinical assesment)
- 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))
研究者
Patricia Corzo
M.D. Rheumatologist consultant
Hospital del Mar