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Application of MRI for Musculoskeletal Involvement in SLE (RMNLES)

Primary Purpose

Hand Rheumatism, Systemic Lupus Erythematosus Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Blood test
Sponsored by
Hospital del Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hand Rheumatism

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital del MarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

pain+ / synovitis +

pain + / synovitis -

pain - / synovitis -

healthy

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

MRI inflamatory changes
synovitis, erosions, bone oedema, tenosynovitis
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)
SLE treatments used
Number (n and %) of participants using any approved treatments for SLE used since diagnosis
Fatigue
Fatigue Severity Scale (FSS-9) Results from 9 (best) to 63 (worst): rating 9 items ranging from 1(best) to 7 (worst)
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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2019
Last Updated
July 29, 2019
Sponsor
Hospital del Mar
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1. Study Identification

Unique Protocol Identification Number
NCT04035265
Brief Title
Application of MRI for Musculoskeletal Involvement in SLE
Acronym
RMNLES
Official Title
Application of MRI for Inflammatory Musculoskeletal Involvement in Systemic Lupus Erithematosus (SLE)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Mar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Rheumatism, Systemic Lupus Erythematosus Arthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Lupus with synovitis Lupus with joint pain Lupus without synovitis/joint pain Healthy subjects
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pain+ / synovitis +
Arm Type
Active Comparator
Arm 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
Arm Title
pain + / synovitis -
Arm Type
Active Comparator
Arm 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
Arm Title
pain - / synovitis -
Arm Type
Active Comparator
Arm Description
SLE patients without inflammatory pain with normal physical examination currently or over the past year
Arm Title
healthy
Arm Type
Placebo Comparator
Arm 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 +)
Intervention Type
Procedure
Intervention Name(s)
Blood test
Other Intervention Name(s)
hand MRI
Intervention Description
Carpus and fingers of non-dominating hand MRI with gadolinium contrast
Primary Outcome Measure Information:
Title
MRI inflamatory changes
Description
synovitis, erosions, bone oedema, tenosynovitis
Time Frame
1 to 2 months after clinical assesment
Title
SLE activity scale
Description
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
Title
SLE treatments used
Description
Number (n and %) of participants using any approved treatments for SLE used since diagnosis
Time Frame
at clinical assesment
Title
Fatigue
Description
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
Title
Quality of life scale
Description
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
Title
SLE damage scale
Description
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 Outcome Measure Information:
Title
Serological markers of disease activity: antinuclear antibodies (ANA)
Description
ANA (dilution): given by titters (average titters comapred between groups)
Time Frame
6 months prior to 6 months after assesment
Title
Systemic SLE manifestations
Description
presence of renal, lung, skin, neurological, haematological manifestations since diagnostic (Yes/No)
Time Frame
at clinical assesment
Title
Hand pain visual analogue scale (VAS)
Description
VAS 0 (none) to 10 (maximum)
Time Frame
at clinical assesment
Title
Serological markers of disease activity: Anti-double stranded DNA antibody (DNAds)
Description
Titters DNAds (UI/ml)
Time Frame
6 months prior to 6 months after assesment (the closest to MRI)
Title
Serological markers of disease activity: Anti-Smith antibodies (Sm)
Description
Presence of Sm (Yes/No)
Time Frame
6 months prior to 6 months after assesment (the closest to MRI)
Title
Serological markers of disease activity: complement 3 (C3)
Description
titters C3 (mg/dL)
Time Frame
6 months prior to 6 months after assesment (the closest to MRI)
Title
Serological markers of disease activity: complement 4 (C4)
Description
titters C4 (mg/dl)
Time Frame
6 months prior to 6 months after assesment (the closest to MRI)
Title
Serological markers of disease activity: erythrocyte sedimentation rate (ESR)
Description
ESR (mm/h)
Time Frame
6 months prior to 6 months after assesment (the closest to MRI)
Title
Serological markers of disease activity: C reactive protein (CRP)
Description
CRP (mg/dl)
Time Frame
6 months prior to 6 months after assesment (the closest to MRI)
Title
Serological markers of disease activity:white cell blood count (WCBC)
Description
WCBC: cellsx10E9/L
Time Frame
6 months prior to 6 months after assesment (the closest to MRI)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Corzo, MD
Phone
+34655057358
Email
pcorzoreumatologia@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek Carlos Salman, PhD
Email
tareto4@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PAtricia corzo, MD
Organizational Affiliation
Hospital del Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PAtricia Corzo Salman, MD
Phone
+34655057358
Email
pcorzoreumatologia@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be used for PhD investigations. IPD will not be shared with other researchers
Citations:
PubMed Identifier
22179731
Citation
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.
Results Reference
background
PubMed Identifier
25183245
Citation
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.
Results Reference
background
PubMed Identifier
25341505
Citation
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. 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].
Results Reference
background
PubMed Identifier
15972342
Citation
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.
Results Reference
background
PubMed Identifier
12784422
Citation
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.
Results Reference
background
PubMed Identifier
17392347
Citation
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.
Results Reference
background

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Application of MRI for Musculoskeletal Involvement in SLE

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