Juvenile Idiopathic ArthritisNCT05545098
MSUS Versus Serum Survivin and Lubricin Levels in Evaluation of Disease Activity in JIA
An observational study of Juvenile Idiopathic Arthritis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Child, Adult
Study population: This study will be conducted on JIA patients recruited from the Rheumatology inpatient and outpatient clinic at Assiut University Children Hospital
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Musculoskeletal Ultrasound Versus Serum Survivin and Lubricin Levels in Evaluation of Disease Activity in Juvenile Idiopathic Arthritis
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.
Read the detailed description
Background:
Juvenile idiopathic arthritis (JIA) is a heterogeneous group of diseases which encompasses all forms of arthritis of unknown etiology lasting for at least 6 weeks and with onset before the age of 16. The International League of Associations for Rheumatology (ILAR) has defined seven subtypes of JIA.
Understanding of the JIA pathogenesis over the last two decades have revolutionized therapy, reduced morbidity, and improved quality of life for those affected . Various autoantibodies have been associated with JIA, including anti-nuclear antibodies (ANA), rheumatoid factor (RF), anti-citrullinated protein autoantibodies (ACPA), and others. Although the ANA test is not used to diagnose JIA, it is of high prognostic value with respect to the risk of uveitis. ANA positivity among the JIA subtypes is the highest in patients with oligoarticular JIA (up to 70%) and is particularly more prevalent in young, female patients. The prevalence of RF in patients with JIA is very low (< 5%), and it confers a worse prognosis. In particular, RF-positive polyarticular patients are at higher risk of a more aggressive disease course and bone erosion. ACPA positive children with JIA are recommended for earlier and more aggressive therapy. Nevertheless, the diagnosis of JIA still depends mainly on clinical characteristics, imaging examination, and exclusion of other, more common causes of persistent arthritis with low serological support. Therefore, it is necessary to establish alternate methods or discover new biomarkers to further improve precise JIA diagnosis at the early stage of the disease.
Lubricin, encoded by the proteoglycan 4 (PRG4) gene, is a mucin-like molecule and includes proline, serine and threonine that provides a scaffold for glycosylation, high viscosity and low friction . It is suggested to have protective effects against synovial hyperplasia and cartilage deterioration in the joint spaces. Experimental models of osteoarthritis showed that lubricin retards cartilage degeneration, enhances cartilage repair and reduces chondrocyte apoptosis.Lubricin levels were also diminished in synovial fluid of inflammatory arthritis. Furthermore, lubricin was recently suggested to act as an antagonist for Toll like receptor (TLR 2)and (TLR 4), preventing its activation in inflammatory arthritis.Moreover, a recent study proposed a new mechanism of lubricin, including inhibition of interleukin 1β (IL-1β) and tumor necrosis factor-α (TNF-α) via CD44 binding.
Survivin is an anti-apoptotic oncoprotein, known as a tissue marker of cancer. During recent years, the role of survivin in non-malignant cells was intensively explored. Survivin has been shown essential for the differentiation, growth, and regeneration of healthy tissues. Due to its role in apoptosis and proliferation, it plays important roles in the pathogenesis of autoimmune diseases. At the preclinical phase of JIA, high levels of survivin correlate with cytokines and anticipate the formation of aggressive T helper cells (Th1) and (Th17) cells. In patients after JIA diagnosis, survivin predicts joint destructive course of the disease and resistance to anti-rheumatic treatment. Survivin has been suggested as a predictive marker of a severe course of adult RA and could be used for preclinical recognition of the disease. Survivin positive patients have poor outcomes if treated with methotrexate (MTX) monotherapy. A decrease in serum survivin concentration is associated with a better clinical response to treatment.
Compared to clinical examination and conventional radiology, musculoskeletal ultrasound (MSUS) is a more sensitive method for detecting synovitis, tenosynovitis, and erosive bone disease. In JIA, MSUS is helpful in the detection of subclinical synovitis, early diagnosis, patient classification, disease activity monitoring, determining disease remission, and guiding intra-articular injections. MSUS is a suitable imaging modality for children as it requires neither sedation nor general anesthesia and no ionizing radiation, is easily repeated, compares between joints, and allows dynamic study and multisite assessment in the same session Despite therapy advances in JIA, patients can achieve only symptoms alleviation but cannot be completely cured. Therefore, exploring the pathogenesis of the rheumatoid process is of high importance for developing precise, personalized treatments and new drug targets.
- Conditions
- Juvenile Idiopathic Arthritis
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 2 months
To perform MSUS on the involved joints.
MSUS will be done to JIA patients to detect:
- Synovitis: presence of joint effusion and/or synovial hypertrophy Synovitis will be graded using score from 0 to 3. 0 no synovitis
- minimal synovitis in joint recess up to the joint capsule.
- synovitis in the entire joint recess causing bulging of the joint capsule.
- 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.
- mild (single/vessel dots).
- moderate (confluent vessel dots in < of the synovial area).
- 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.
Measured: 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.
The JADAS includes the following four measures:
- Physician's global assessment of disease activity, measured on a 0-10 visual analog scale (VAS) where 0 = no activity and 10 = maximum activity;
- Parent global assessment of well-being, measured on a 0-10 VAS where 0 = very well and 10 = very poor
- The erythrocyte sedimentation rate (ESR), normalized to a 0 to 10 scale according to the following formula (ESR(mm/hr)-20/10) ESR values 20 mm/hr are given 0 points ESR values 120 mm/hr are given 10 points
- Count of joints with active disease. JADAS27 includes a selected count of the following joints: cervical spine, elbows, wrists, metacarpophalangeal joints (from first to third), proximal interphalangeal joints, hips, knees and ankles.
Measured: 3 months
To identify the prevalence of functional disability in JIA children and adolescents using the childhood health assessment questionnaire (CHAQ).
Childhood Health Assessment Questionnaire (CHAQ) :
Describes the child's usual activities in eight domains over the past week. It include dressing, getting up, eating, walking, hygiene, reaching overhead objects, grip and activities. Each question is scored from 0 to 3 (0 = no difficulty, 1 = some difficulty, 2 = much difficulty and 3 = unable to do). The score for each of the eight functional areas will be averaged to calculate the disability index. Patients will be classified as mildly disabeled (score >1) , moderately disabeled ) score 1-2) or severely disabeled (score <2) .
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yostina Ramzy Gadallah Ghattas, Assiut University
- Investigators
- Mohamed G Mohamed, Ass prof, Study director, Assiut UniversityManal M Ahmed, Ass prof, Study director, Assiut UniversityNagwa A Mohamed, Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545098
- Sponsor's protocol ID
- Juvenile idiopathic arthritis
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33494811Mosa DM, Abdelrahman AM, El-Bahnasawy AS. Ultrasound Features across Subtypes of Juvenile Idiopathic Arthritis. Rheumato. 2022;2(1):2-14.
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.
PubMed 35079181Petty 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.
PubMed 14760812Consolaro 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.
PubMed 27089922Consolaro 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.
PubMed 19405003Elsayed 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.
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.
PubMed 29132381Huang 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.
PubMed 33926518
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Musculoskeletal Ultrasound Versus Serum Survivin and Lubricin Levels in Evaluation of Disease Activity in Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT05545098
- Acronym / sponsor ID
- Juvenile idiopathic arthritis
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Juvenile idiopathic arthritis (JIA) is a heterogeneous group of diseases which encompasses all forms of arthritis of unknown etiology lasting for at least 6 weeks and with onset before the age of 16. The International League of Associations for Rheumatology (ILAR) has defined seven subtypes of JIA.
Understanding of the JIA pathogenesis over the last two decades have revolutionized therapy, reduced morbidity, and improved quality of life for those affected . Various autoantibodies have been associated with JIA, including anti-nuclear antibodies (ANA), rheumatoid factor (RF), anti-citrullinated protein autoantibodies (ACPA), and others. Although the ANA test is not used to diagnose JIA, it is of high prognostic value with respect to the risk of uveitis. ANA positivity among the JIA subtypes is the highest in patients with oligoarticular JIA (up to 70%) and is particularly more prevalent in young, female patients. The prevalence of RF in patients with JIA is very low (< 5%), and it confers a worse prognosis. In particular, RF-positive polyarticular patients are at higher risk of a more aggressive disease course and bone erosion. ACPA positive children with JIA are recommended for earlier and more aggressive therapy. Nevertheless, the diagnosis of JIA still depends mainly on clinical characteristics, imaging examination, and exclusion of other, more common causes of persistent arthritis with low serological support. Therefore, it is necessary to establish alternate methods or discover new biomarkers to further improve precise JIA diagnosis at the early stage of the disease.
Lubricin, encoded by the proteoglycan 4 (PRG4) gene, is a mucin-like molecule and includes proline, serine and threonine that provides a scaffold for glycosylation, high viscosity and low friction . It is suggested to have protective effects against synovial hyperplasia and cartilage deterioration in the joint spaces. Experimental models of osteoarthritis showed that lubricin retards cartilage degeneration, enhances cartilage repair and reduces chondrocyte apoptosis.Lubricin levels were also diminished in synovial fluid of inflammatory arthritis. Furthermore, lubricin was recently suggested to act as an antagonist for Toll like receptor (TLR 2)and (TLR 4), preventing its activation in inflammatory arthritis.Moreover, a recent study proposed a new mechanism of lubricin, including inhibition of interleukin 1β (IL-1β) and tumor necrosis factor-α (TNF-α) via CD44 binding.
Survivin is an anti-apoptotic oncoprotein, known as a tissue marker of cancer. During recent years, the role of survivin in non-malignant cells was intensively explored. Survivin has been shown essential for the differentiation, growth, and regeneration of healthy tissues. Due to its role in apoptosis and proliferation, it plays important roles in the pathogenesis of autoimmune diseases. At the preclinical phase of JIA, high levels of survivin correlate with cytokines and anticipate the formation of aggressive T helper cells (Th1) and (Th17) cells. In patients after JIA diagnosis, survivin predicts joint destructive course of the disease and resistance to anti-rheumatic treatment. Survivin has been suggested as a predictive marker of a severe course of adult RA and could be used for preclinical recognition of the disease. Survivin positive patients have poor outcomes if treated with methotrexate (MTX) monotherapy. A decrease in serum survivin concentration is associated with a better clinical response to treatment.
Compared to clinical examination and conventional radiology, musculoskeletal ultrasound (MSUS) is a more sensitive method for detecting synovitis, tenosynovitis, and erosive bone disease. In JIA, MSUS is helpful in the detection of subclinical synovitis, early diagnosis, patient classification, disease activity monitoring, determining disease remission, and guiding intra-articular injections. MSUS is a suitable imaging modality for children as it requires neither sedation nor general anesthesia and no ionizing radiation, is easily repeated, compares between joints, and allows dynamic study and multisite assessment in the same session Despite therapy advances in JIA, patients can achieve only symptoms alleviation but cannot be completely cured. Therefore, exploring the pathogenesis of the rheumatoid process is of high importance for developing precise, personalized treatments and new drug targets.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- This study will be conducted on JIA patients recruited from the Rheumatology inpatient and outpatient clinic at Assiut University Children Hospital
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess Lubricin in the serum and in the synovial fluid if available in JIA patients.
Time frame: 2 months
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
To assess Survivin in the serum and in the synovial fluid if available in JIA patients.
Time frame: 2 months
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).
To perform MSUS on the involved joints.
Time frame: 4 months
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.
2 secondary outcomes
To assess disease activity using Juvenile arthritis disease activity score in 27 joints (JADAS 27) in the studied JIA patients.
Time frame: 3 months
To identify the prevalence of functional disability in JIA children and adolescents using the childhood health assessment questionnaire (CHAQ).
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Background: PubMed 33494811Lipinska 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.
- BackgroundMosa DM, Abdelrahman AM, El-Bahnasawy AS. Ultrasound Features across Subtypes of Juvenile Idiopathic Arthritis. Rheumato. 2022;2(1):2-14.
- Background: PubMed 35079181Ekinci 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.
- Background: PubMed 14760812Petty 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.
- Background: PubMed 27089922Consolaro 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.
- Background: PubMed 19405003Consolaro 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.
- BackgroundElsayed 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: PubMed 29132381Miotto 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.
- Background: PubMed 33926518Huang 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.
Related trials for Juvenile Idiopathic Arthritis
RecruitingPhase 3
A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Recruiting
The Use of Infrared Cameras for Detecting Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis, Infrared Thermography
Not yet recruitingPhase 4
Withdrawal Versus Continued TNF Inhibitor Monotherapy Treatment in Children With Inactive Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingObservational study
Tofacitinib in Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis (JIA)
RecruitingPhase 3
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed G Mohamed, Ass prof study director
Assiut University
Manal M Ahmed, Ass prof study director
Assiut University
Nagwa A Mohamed, Prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yostina R Gadallah (01275655980, yostinaramzy5@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess Lubricin in the serum and in the synovial fluid if available in JIA patients. (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05545098, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.