Application of MRI for Musculoskeletal Involvement in SLE

NCT04035265 | Unknown

• 1 other identifier: RMNLES
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Rheumatism; Systemic Lupus Erythematosus Arthritis

Outcome Measures

Primary Outcomes (6)

• MRI inflamatory changes

  synovitis, erosions, bone oedema, tenosynovitis

  1 to 2 months after clinical assesment

• 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)

  at clinical assesment

• SLE treatments used

  Number (n and %) of participants using any approved treatments for SLE used since diagnosis

  at clinical assesment

• Fatigue

  Fatigue Severity Scale (FSS-9) Results from 9 (best) to 63 (worst): rating 9 items ranging from 1(best) to 7 (worst)

  2 weeks before the performance of MRI

• 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)

  2 weeks before the performance of MRI

• 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)

  at clinical assesment

Secondary Outcomes (10)

• 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)

Study Arms (4)

pain+ / synovitis +

ACTIVE COMPARATOR

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

pain + / synovitis -

ACTIVE COMPARATOR

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

pain - / synovitis -

ACTIVE COMPARATOR

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

Procedure: Blood test

healthy

PLACEBO COMPARATOR

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

Interventions

Blood test PROCEDURE

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

Also known as: hand MRI

healthy; pain + / synovitis -; pain - / synovitis -; pain+ / synovitis +

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 +)

You may not qualify if:

• Jaccoud's arthropaty
• RF + and/or ACPA +
• Incomplete SLE, MCTD, overlap syndromes
• Hand surgery
• Current neoplasia
• Non-rheumatoid systemic autoimmune diseases
• Contraindication for MRI

Sponsors & Collaborators

• Hospital del Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 22179731 BACKGROUND

• 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.

  PMID: 25183245 BACKGROUND

• 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.

  PMID: 25341505 BACKGROUND

• 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.

  PMID: 15972342 BACKGROUND

• 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.

  PMID: 12784422 BACKGROUND

• 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.

  PMID: 17392347 BACKGROUND

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• PAtricia corzo, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Corzo, MD

CONTACT

+34655057358; pcorzoreumatologia@gmail.com

Tarek Carlos Salman, PhD

CONTACT

tareto4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Rheumatologist consultant

Model Details: 1. Lupus with synovitis 2. Lupus with joint pain 3. Lupus without synovitis/joint pain 4. Healthy subjects

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 29, 2019
• Study Start: December 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)