NCT05545098

Brief Summary

Aim of the work The aim of this study is to compare the role of musculoskeletal ultrasound to serum Survivin and Lubricin in detection of disease activity in patients with oligoarticular and polyarticular juvenile idiopathic arthritis. Objectives

  • To assess disease activity using Juvenile arthritis disease activity score in 27 joints (JADAS 27) in the studied JIA patients.
  • To identify the prevalence of functional disability in JIA children and adolescents using the childhood health assessment questionnaire (CHAQ).
  • To perform MSUS on the involved joints.
  • To assess Survivin in the serum and in the synovial fluid if available in JIA patients.
  • To assess Lubricin in the serum and in the synovial fluid if available in JIA patients.
  • To compare the disease activity across individual patients using JADAS 27, MSUS and their relation to serum level of Survivin and lubricin.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

September 3, 2022

Last Update Submit

September 14, 2022

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (3)

  • To assess Lubricin in the serum and in the synovial fluid if available in JIA patients.

    Lubricin will be assessed in a serum sample that will be collected from JIA patients and controls and if possible from a synovial fluid sample that will be obtained from swollen joints from patients with active disease state. The serum and synovial fluid

    2 months

  • To assess Survivin in the serum and in the synovial fluid if available in JIA patients.

    Survivin will be assessed in a serum sample that will be collected from JIA patients and controls and if possible from a synovial fluid sample that will be obtained from swollen joints from patients with active disease state. The serum and synovial fluid samples will be centrifuged and stored at - 80 °C. and the concentration of survivin and lubricin will be determined by a enzyme-linked immunoassay (ELISA test) in the serum and matched synovial fluid samples of patients with JIA and in the serum of children from the control group, by commercially available kits(rabbit anti-human survivin; R\&D, no DSV00, Lille,France).

    2 months

  • To perform MSUS on the involved joints.

    MSUS will be done to JIA patients to detect: A. Synovitis: presence of joint effusion and/or synovial hypertrophy Synovitis will be graded using score from 0 to 3. 0 no synovitis 1. minimal synovitis in joint recess up to the joint capsule. 2. synovitis in the entire joint recess causing bulging of the joint capsule. 3. synovitis in joint recess with bulging of the joint capsule and extension to at least one bone diaphysis. B. Blood flow: defined by defined by the presence of PD signal performed only in areas where synovitis will be detected PDUS will be graded using score from 0 to 3. 0 no signs of vascularization. 1. mild (single/vessel dots). 2. moderate (confluent vessel dots in \< of the synovial area). 3. marked (confluent vessel dots in ≥ of the synovial area). The sum of grey scale (GS) and power Doppler (PD) as GSPD will be calculated. The joint with the highest GSPD will be selected as the indicator joint.

    4 months

Secondary Outcomes (2)

  • To assess disease activity using Juvenile arthritis disease activity score in 27 joints (JADAS 27) in the studied JIA patients.

    3 months

  • To identify the prevalence of functional disability in JIA children and adolescents using the childhood health assessment questionnaire (CHAQ).

    3 months

Study Arms (2)

JIA patients

* Assessment of Survivin and Lubricin in the serum and in the Synovial fluid if available in JIA patients * Assessment of activity using Juvenile arthritis disease activity score in 27 joints (JADAS 27) in the studied JIA patients. * Identifying the prevalence of functional disability in JIA children and adolescents using the childhood health assessment questionnaire (CHAQ). * performing MSUS on the involved joints.

control group

Assessment of Survivin and Lubricin in the serum

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

This study will be conducted on JIA patients recruited from the Rheumatology inpatient and outpatient clinic at Assiut University Children Hospital

You may qualify if:

  • Patients of both sexes less than 16 years at onset of disease and diagnosed with oligoarticular and polyarticular JIA, fulfilling the ILAR classification criteria of JIA, The patients will be divided according to the subtypes of JIA disease.
  • Control group will include age-and-sex-matched apparently healthy children.

You may not qualify if:

  • Patients having associated neurological or disabling diseases.
  • Patients with diabetes mellitus, acute or chronic infections.
  • Patients with another types of JIA other than oligoarticular and polyarticular JIA (due to different patterns and diagnostic criteria of these types of JIA)
  • Patients with another causes of arthritis other than JIA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Lipinska J, Kaszkowiak M, Malachowska B, Swidrowska-Jaros J, Smolewska E. Concentration of survivin in children with oligo- and polyarticular juvenile idiopathic arthritis (JIA): diagnostic and prognostic value-a single-center study. Arthritis Res Ther. 2021 Jan 26;23(1):40. doi: 10.1186/s13075-021-02424-y.

    PMID: 33494811BACKGROUND

  • Mosa DM, Abdelrahman AM, El-Bahnasawy AS. Ultrasound Features across Subtypes of Juvenile Idiopathic Arthritis. Rheumato. 2022;2(1):2-14.

    BACKGROUND

  • Ekinci RMK, Balci S, Coban F, Bisgin A. Serum lubricin levels in patients with juvenile idiopathic arthritis. Reumatologia. 2021;59(6):373-377. doi: 10.5114/reum.2021.111696. Epub 2021 Dec 9.

    PMID: 35079181BACKGROUND

  • Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, He X, Maldonado-Cocco J, Orozco-Alcala J, Prieur AM, Suarez-Almazor ME, Woo P; International League of Associations for Rheumatology. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004 Feb;31(2):390-2. No abstract available.

    PMID: 14760812BACKGROUND

  • Consolaro A, Giancane G, Schiappapietra B, Davi S, Calandra S, Lanni S, Ravelli A. Clinical outcome measures in juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2016 Apr 18;14(1):23. doi: 10.1186/s12969-016-0085-5.

    PMID: 27089922BACKGROUND

  • Consolaro A, Ruperto N, Bazso A, Pistorio A, Magni-Manzoni S, Filocamo G, Malattia C, Viola S, Martini A, Ravelli A; Paediatric Rheumatology International Trials Organisation. Development and validation of a composite disease activity score for juvenile idiopathic arthritis. Arthritis Rheum. 2009 May 15;61(5):658-66. doi: 10.1002/art.24516.

    PMID: 19405003BACKGROUND

  • Elsayed Mostafa W, Bakry Abdul-sattar A, Abo Elsaud Dawa G. Prevalence and factors of functional disability in patients with juvenile idiopathic arthritis. Zagazig University Medical Journal. 2019;25(3):456-63.

    BACKGROUND

  • Miotto E Silva VB, Mitraud SAV, Furtado RNV, Natour J, Len CA, Terreri MTSELRA. Patients with juvenile idiopathic arthritis in clinical remission with positive power Doppler signal in joint ultrasonography have an increased rate of clinical flare: a prospective study. Pediatr Rheumatol Online J. 2017 Nov 13;15(1):80. doi: 10.1186/s12969-017-0208-7.

    PMID: 29132381BACKGROUND

  • Huang YH, Hu YC, Liao CH, Chiang BL, Lu CH, Li KJ, Yang YH. Utilizing ultrasound findings of a single indicator joint to assess non-systemic juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2021 Apr 29;19(1):60. doi: 10.1186/s12969-021-00550-0.

    PMID: 33926518BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mohamed G Mohamed, Ass prof

    Assiut University

    STUDY DIRECTOR

  • Manal M Ahmed, Ass prof

    Assiut University

    STUDY DIRECTOR

  • Nagwa A Mohamed, Prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Yostina R Gadallah

CONTACT

01275655980yostinaramzy5@yahoo.com

Naglaa S Mohamed, Lecturer

CONTACT

01002673103Naglaaosman84@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 19, 2022

Study Start

September 1, 2022

Primary Completion

May 1, 2024

Study Completion

August 1, 2024

Last Updated

September 19, 2022

Record last verified: 2022-09