Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413563
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-09
Brief Title:
Analysis of Peripheral Blood Lymphocytes in Patients With Juvenile Idiopathic Arthritis With Respect to Disease Subtypes and Therapy
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Analysis of Peripheral Blood Lymphocytes in Patients With Juvenile Idiopathic Arthritis With Respect to Disease Subtypes and Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Juvenile idiopathic arthritis JIA is the most common chronic rheumatic disease in children
JIA is an umbrella term defining several forms of chronic arthritis with an onset before the age of 16 years persisting for more than six weeks and with an unknown cause
Based on the current International League of Associations in Rheumatology classification criteria ILAR 2003 different subtypes of JIA can be distinguished essentially by a very limited set of clinical features number of affected joints in the first six months of disease extra-articular manifestations like fever or features of psoriasis and serology presence or absence of rheumatoid factor RF The most frequently diagnosed JIA subtypes are oligoarticular JIA oJIA polyarticular JIA pJIA and systemic JIA sJIA Less frequently occurring subtypes are enthesitis-related JIA psoriatic arthritis and undefined arthritis
The pathophysiology mechanisms associated to JIA development are related to an abnormal activation of immune system cells such as B cells T cells natural killer NK cells dendritic cells DCs monocytes neutrophils plasma cells and to the production and release of pro-inflammatory mediators that ultimately lead to cartilage and bone destruction and systemic manifestations
JIA has been classically considered a T-cell driven autoimmune disease except for sJIA subtype in which innate immune cells have a central role in disease pathogenesis However the detection of autoantibodies reacting with different target antigens in JIA patients suggests a central role of B cells in JIA pathophysiology
Therapeutic intervention of jia begins at diagnosis with non-steroidal anti-inflammatory drugs NSAIDs followed by disease-modifying anti-rheumatic drugs DMARDs most often methotrexate andor corticosteroid intra-articular injection
NSAIDs obtain both analgesic and anti-inflammatory effects Local corticosteroid joint injections are effective in synovitis and may be a first-line treatment for oligoarthritis alone or in addition to DMARDs Systemic administration of high dose corticosteroids provides good short-term effect especially in sJIA patients
The American College of Rheumatology ACR recommends early use of DMARDs specifically MTX leflunomide andor sulfasalazine
MTX is considered to be the first choice DMARD for oligo- and pJIA when NSAIDs and intraarticular steroids are insufficient
MTX is also considered to be effective in children with PsJIA though the axial manifestations limits prescription of MTX and so TNF inhibitors are typically required in these cases
Leflunomide may be used as an alternative DMARD for pJIA in cases of MTX intolerance
Sulfasalazine is recommended for patients with moderate activity of ERA with active peripheral arthritis but is inefficient in case of sacroiliitis
The emergence of biologic treatments has changed the prognosis for many JIA patients whose condition did not improve adequately on conventional synthetic disease modifying anti-rheumatic drugs csDMARDs mainly methotrexate or experienced side effects because of them TNF-α inhibitors such as etanercept adalimumab infliximab are widely used in JIA In fact etanercept is one of the most frequently prescribed biologics for JIA in many countries including the United Kingdom 19 Other biologics include tocilizumab anakinra and canakinumab abatacept and rituximab The efficacy of biologics varies depending on the disease subtype
Most healthy children have episodes of mild infections during the first years of life In most cases these episodes are respiratory or gastrointestinal viral infections Children with juvenile idiopathic arthritis JIA have an allegedly higher risk of infection compared with healthy children because of their underlying condition
Treatments used in JIA include corticosteroids disease-modifying antirheumatic drugs DMARDs and biologic agents all of which can increase the frequency of common mild infections and the risk of severe and opportunistic infections
Disease-modifying anti-rheumatic drugs DMARDs help manage JIA by reducing inflammation and preventing joint damage slowing the progression of the disease
These therapies work by suppressing the immune system which can lead to infection despite growing evidence regarding the efficacy and safety of these drugs for children with JIA it is unclear whether these agents increase the risk of infections - or whether the risk is increased to all or to only specific infections
Moreover there is a proportional relationship between the severity of the disease and the intensity of the treatment administered and this association might constitute a confounding factor when assessing susceptibility to infections
Besides novel findings there is still little data available regarding the alteration of immune cells which control infection
JIA is an umbrella term defining several forms of chronic arthritis with an onset before the age of 16 years persisting for more than six weeks and with an unknown cause
Based on the current International League of Associations in Rheumatology classification criteria ILAR 2003 different subtypes of JIA can be distinguished essentially by a very limited set of clinical features number of affected joints in the first six months of disease extra-articular manifestations like fever or features of psoriasis and serology presence or absence of rheumatoid factor RF The most frequently diagnosed JIA subtypes are oligoarticular JIA oJIA polyarticular JIA pJIA and systemic JIA sJIA Less frequently occurring subtypes are enthesitis-related JIA psoriatic arthritis and undefined arthritis
The pathophysiology mechanisms associated to JIA development are related to an abnormal activation of immune system cells such as B cells T cells natural killer NK cells dendritic cells DCs monocytes neutrophils plasma cells and to the production and release of pro-inflammatory mediators that ultimately lead to cartilage and bone destruction and systemic manifestations
JIA has been classically considered a T-cell driven autoimmune disease except for sJIA subtype in which innate immune cells have a central role in disease pathogenesis However the detection of autoantibodies reacting with different target antigens in JIA patients suggests a central role of B cells in JIA pathophysiology
Therapeutic intervention of jia begins at diagnosis with non-steroidal anti-inflammatory drugs NSAIDs followed by disease-modifying anti-rheumatic drugs DMARDs most often methotrexate andor corticosteroid intra-articular injection
NSAIDs obtain both analgesic and anti-inflammatory effects Local corticosteroid joint injections are effective in synovitis and may be a first-line treatment for oligoarthritis alone or in addition to DMARDs Systemic administration of high dose corticosteroids provides good short-term effect especially in sJIA patients
The American College of Rheumatology ACR recommends early use of DMARDs specifically MTX leflunomide andor sulfasalazine
MTX is considered to be the first choice DMARD for oligo- and pJIA when NSAIDs and intraarticular steroids are insufficient
MTX is also considered to be effective in children with PsJIA though the axial manifestations limits prescription of MTX and so TNF inhibitors are typically required in these cases
Leflunomide may be used as an alternative DMARD for pJIA in cases of MTX intolerance
Sulfasalazine is recommended for patients with moderate activity of ERA with active peripheral arthritis but is inefficient in case of sacroiliitis
The emergence of biologic treatments has changed the prognosis for many JIA patients whose condition did not improve adequately on conventional synthetic disease modifying anti-rheumatic drugs csDMARDs mainly methotrexate or experienced side effects because of them TNF-α inhibitors such as etanercept adalimumab infliximab are widely used in JIA In fact etanercept is one of the most frequently prescribed biologics for JIA in many countries including the United Kingdom 19 Other biologics include tocilizumab anakinra and canakinumab abatacept and rituximab The efficacy of biologics varies depending on the disease subtype
Most healthy children have episodes of mild infections during the first years of life In most cases these episodes are respiratory or gastrointestinal viral infections Children with juvenile idiopathic arthritis JIA have an allegedly higher risk of infection compared with healthy children because of their underlying condition
Treatments used in JIA include corticosteroids disease-modifying antirheumatic drugs DMARDs and biologic agents all of which can increase the frequency of common mild infections and the risk of severe and opportunistic infections
Disease-modifying anti-rheumatic drugs DMARDs help manage JIA by reducing inflammation and preventing joint damage slowing the progression of the disease
These therapies work by suppressing the immune system which can lead to infection despite growing evidence regarding the efficacy and safety of these drugs for children with JIA it is unclear whether these agents increase the risk of infections - or whether the risk is increased to all or to only specific infections
Moreover there is a proportional relationship between the severity of the disease and the intensity of the treatment administered and this association might constitute a confounding factor when assessing susceptibility to infections
Besides novel findings there is still little data available regarding the alteration of immune cells which control infection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None