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Ultrasound-Based Detection Of Subclinical Arthritis Among Patients With Systemic Lupus

Primary Purpose

Ultrasound

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cases diagnosed as SLE according to the 2019 ACR/EULAR classification criteria. Agreeing to be included in the study Age >18 years Exclusion Criteria: Patients with clinical SLE arthritis Patients of Rhupus and patients with any collagen disease that causes arthritis other than systemic lupus erythematosus.

Sites / Locations

  • Sohag university hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

50 character

Arm Description

Outcomes

Primary Outcome Measures

subclinical arthritis
detection of subclinical arthritis by ultrasound in SLE patients

Secondary Outcome Measures

Full Information

First Posted
April 16, 2023
Last Updated
May 3, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05844917
Brief Title
Ultrasound-Based Detection Of Subclinical Arthritis Among Patients With Systemic Lupus
Official Title
Ultrasound-Based Detection Of Subclinical Arthritis Among Patients With Systemic Lupus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to assess the prevalence and precise grading of US abnormalities of the hand and wrist in asymptomatic patients with SLE, while comparing these findings with a group of patients with SLE with musculoskeletal signs or symptoms and with healthy controls.
Detailed Description
Systemic Lupus Erythematosus (SLE) is a chronic inflammatory autoimmune disorder associated with a wide range of symptoms and physical findings. It is characterized by loss of tolerance to self-antigens, formation of immune complexes, and an activated type I interferon system . Joint involvement is one of the most common features of systemic lupus erythematosus (SLE), with up to 95% of patients experiencing arthralgia or arthritis during the course of their disease . While multiple joints can be affected, nearly 50% of patients report difficulties in daily life performance due to hand symptoms . Traditionally, SLE arthritis is considered to be mild, reversible and non-erosive, with only 5-15% of cases progressing to deforming arthropathy, either erosive-as in rhupus syndrome (an overlap of SLE with rheumatoid arthritis (RA))-or non-erosive-as in Jaccoud's arthropathy . In routine clinical practice, joint involvement is usually assessed with physical examination and radiographical studies. However, this approach has been shown to have a low sensitivity for joint abnormalities when compared with ultrasound (US) evaluation or MRI, suggesting that the burden of joint inflammation may be underestimated in the current clinical practice . The value of US with power Doppler (PD) in inflammatory arthritis has been extensively demonstrated in the literature, with similar sensitivity and specificity in the detection of synovitis in comparison with MRI, with the advantage of being more accessible and less expensive . While US shows the morphology of the synovial membrane, PD identifies increased vascularisation within it, allowing for the detection of active joint inflammation. It is known that in RA synovial abnormalities are present before clinically evident arthritis develops, and that early treatment can limit erosive changes and avoid disease progression. In this context, US PD has nowadays an established role in the detection of subclinical joint inflammation in RA, namely to predict progression in patients with clinical remission . Although there is evidence that US PD is a valuable technique in the evaluation of musculoskeletal symptoms in SLE, the prevalence of subclinical joint abnormalities in SLE remains to be defined. Furthermore, while it is known that minimal synovial proliferation may be seen in up to 50% of healthy subjects, the distinction between 'normal' synovial hypertrophy (SH) and pathological subclinical synovitis in SLE still requires clarification .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
50 character
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ultrasound
Intervention Description
Ultrasound detection of subclinical arthritis among Patients With SLE
Primary Outcome Measure Information:
Title
subclinical arthritis
Description
detection of subclinical arthritis by ultrasound in SLE patients
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cases diagnosed as SLE according to the 2019 ACR/EULAR classification criteria. Agreeing to be included in the study Age >18 years Exclusion Criteria: Patients with clinical SLE arthritis Patients of Rhupus and patients with any collagen disease that causes arthritis other than systemic lupus erythematosus.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aya A Abdelbaset, Resident
Phone
01000527960
Email
ayaelkady305@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed R Alagamy, Ass.Professor
Facility Information:
Facility Name
Sohag university hospital
City
Sohag
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
31385462
Citation
Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930. Epub 2019 Aug 6.
Results Reference
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PubMed Identifier
31383717
Citation
Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. Ann Rheum Dis. 2019 Sep;78(9):1151-1159. doi: 10.1136/annrheumdis-2018-214819. Epub 2019 Aug 5.
Results Reference
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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
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PubMed Identifier
15020323
Citation
Bresnihan B, Kane D. Sonography and subclinical synovitis. Ann Rheum Dis. 2004 Apr;63(4):333-4. doi: 10.1136/ard.2003.015982. No abstract available.
Results Reference
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Ultrasound-Based Detection Of Subclinical Arthritis Among Patients With Systemic Lupus

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