Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06227559 |
| Other study ID # |
Juvenile systemic lupus |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2024 |
| Est. completion date |
June 1, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Juvenile systemic lupus erythematosus is an autoimmune disorder with multisystem involvement,
leading to inflammatory damage to the joints, kidney, central nervous system, and
hematopoietic system. Although the prevalence rate of juvenile systemic lupus erythematosus
in a developing country is not known, as per literature the female-to-male ratio rises from
4.5 : 1 in adolescence to 8--12 : 1 in adult-onset patients.
- The full mechanism of SLE is still unknown however, production of autoantibodies and immune
complex deposition with subsequent infiltration of neutrophils, hyper-activation of B and T
cells, reduced ability of immune complexes and apoptotic cell clearance, and defects in
multiple immune regulatory networks, are central to organ inflammation and subsequent damage
in SLE. Systemic lupus erythematosus goes on with organ involvements by remission and
relapses.
Description:
Juvenile systemic lupus erythematosus is an autoimmune disorder with multisystem involvement,
leading to inflammatory damage to the joints, kidney, central nervous system, and
hematopoietic system. Although the prevalence rate of juvenile systemic lupus erythematosus
in a developing country is not known, as per literature the female-to-male ratio rises from
4.5 : 1 in adolescence to 8--12 : 1 in adult-onset patients.
- The full mechanism of SLE is still unknown however, production of autoantibodies and immune
complex deposition with subsequent infiltration of neutrophils, hyper-activation of B and T
cells, reduced ability of immune complexes and apoptotic cell clearance, and defects in
multiple immune regulatory networks, are central to organ inflammation and subsequent damage
in SLE. Systemic lupus erythematosus goes on with organ involvements by remission and
relapses.
The patients with SLE may present with various systemic manifestations. The general symptoms
include: fever, malaise, arthralgias, myalgias, headache, and loss of appetite and weight.
Nonspecific fatigue, fever, arthralgia, and weight changes.
- JSLE prognosis is related to the affected organs/systems and is worse for children and
adolescents compared to adults, perhaps due to the higher rate of renal and neurological
involvement attributed to JSLE.
Over the last decades, the improvement of patient survival was mainly due to an early
diagnosis and better therapeutic approach, especially regarding the severe manifestations of
the disease. These included the introduction of hemodialysis, renal transplantation and use
of immunosuppressive drugs and their complications, i.e., use of potent antibiotic and
hypertensive drugs .
- it is noteworthy that the hematological involvment predominates during the first years
of the disease and tends to last over time, with the premise that it may be the initial
manifestation of the disease. Clear examples of this are the cases of hemolytic anemia
and immune thrombocytopenia that can be initially classified as idiopathic or primary to
be later classified as secondary when associated with infections, medications,
neoplasms, or autoimmune diseases. The spectrum of hematologic manifestations in SLE is
very broad, including lymphopenia, anemia, thrombocytopenia, or pancytopenia.
- Platelet system activation is a key event in the pathogenesis of SLE. Circulating immune
complexes, anti-phospholipid antibodies and infectious agents such as virus are the main
activators of platelets in SLE. Neutrophil to lymphocyte ratio (NLR) and platelet to
lymphocyte ratio (PLR) are two of the complete blood count parameters. A high NLR is
used as an inflammatory marker for different autoimmune diseases. High PLR has been used
as a marker for differential diagnosis or prognostic prediction of different diseases
such as inflammatory diseases .
Over the past decade, PLR has emerged as a universal laboratory marker for predicting various
neoplastic, prothrombotic, and metabolic diseases. PLR fluctuations can be interpreted in the
context of the underlying multifaceted immune-inflammatory reactions. Shifts in this
parameter correlate positively with other markers of systemic inflammation, particularly with
NLR. PLR better predicts clinical outcomes in patients with systemic inflammation than either
platelet or lymphocyte count .
- In previous studies, The major organ systems studied were: renal, hematological,
cardiac, pulmonary, hepatic and the central nervous system. The results showed that a
high percentage of children had hematological involvement (34%); thrombocytopenia (23%)
and hemolytic anemia (20%).
- JSLE is not rare in Egypt and Africa, representing an important subset that is commonly
over looked and requires special attention.
