The Effect of Some Drugs Used in Treatment of Vasculitis on the Complement System in Children
NCT ID: NCT03692416
Last Updated: 2021-02-15
Study Results
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Basic Information
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UNKNOWN
PHASE3
70 participants
INTERVENTIONAL
2018-11-11
2022-05-11
Brief Summary
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Complement activation at C3 and C4 was thought to be involved in renal damage ANCA associated vasculitis (AAV).
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Detailed Description
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ANCA associated vasculitis may be due complex interplay of genetic risks, environmental or infection trigger or adaptive immunity leading to insufficient regulation of B cells with pathogenic ANCA generation and neutrophil activation (AAV).
Complement activation at C3 and C4 was involved in organ damage, especially renal, in AAV at the alternative complement pathway, factor B and properdin component colocalized with C3 complement in the endothelium of the blood vessels.
Furthermore, the common complement pathway was activated as reflected by increased C5a levels. This suggests that both the alternative and common complement pathways are involved in some cases of vasculitis. Furthermore a decrease in these activation factors was observed during remission of vasculitis. This may denote clearance of the degradation of cell component that were blocking inactive vasculitis. In addition, many studies noticed strong increased plasma levels of the anaphlatoxin C5a that has a strong proinflammatory activity on the endothelium of vessels that may be related to disease severity. So much so, that inhibition of C5a levels by immunologic inhibitors may have a therapeutic role in some forms of ANCA positive vasculitis.
Various treatment forms have been used for vasculitis syndromes.
* Drugs used in treatment of Juvenile Idiopathic Arthritis (JIA) are:
1. Non-steroidal Anti-inflammatory Drugs (NSAIDs) such as Salicylates e.g. Aspirin, Selective COX-2 inhibitors e.g. Celecoxib \& Non-Selective COX-2 inhibitors e.g. Naproxen.
2. Non-biologic Disease-Modifying Anti-rheumatic drugs such as Methotrexate.
3. Biologic Disease-Modifying Anti-rheumatic Drugs such as Infliximab.
4. Oral or parenteral Glucocorticoids such as Methylprednisolone (According to American College of Rheumatology).
* In cases of SLE, the American College of Rheumatology (ACR) recommended corticosteroids in the 1st place and change to or add Biologic Disease-Modifying Anti-rheumatic Drugs Agents such as Rituximab.
* Regarding Henoch-Schonlein Purpura vasculitis, 70% of cases are self-limited. only cases with suspected renal involvement e.g. hematuria, hypertension, headache or proteinuria are to be treated with sreroids.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ibuprofen
Patients in this group will receive:
Ibuprofen
* Oral
* At a dosage of 30 to 40 mg/kg/day, divided into 3 or 4 doses/day, max 2400 mg/day, given with food, in the form of suspension or tablets.
* Duration of therapy: 4 - 6 weeks.
Ibuprofen
Infants and children with vasculitis attending AssiutU, aged \> 1 mo. - 17 yr. of both genders will be included during 2 years of study.
Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests \& Albumin / creatinine ratio.
All cases will have an initial estimation as well as follow up estimation after treatment by Ibuprofen for ANCA, C3, C4 \&C5a levels done, measured By ELISA technique.
Prednisone Oral or Methylprednisolone IV
Steroids:
1. Pednisone (for mild/moderate cases):
* Oral
* Single daily morning dosage of 0.05-2.0 mg/kg/day, or in 2 - 4 divided doses, max 80 mg/d.
* Duration: 4 - 6 weeks, with gradual tapering to the lowest effective dose.
2. Methylprednisolone (for severe/acute cases):
* IV
* 10-30 mg/kg/dose (max 1 g), over 1 hr daily for 1-5 days, followed by oral prednisone, with gradual tapering to the lowest effective dose.
* The duration is variable according to the condition of the patient.
Prednisone
Infants and children with vasculitis attending AssiutU, aged \> 1 mo. - 17 yr. of both genders will be included during 2 years of study.
Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests \& Albumin / creatinine ratio.
All cases will have an initial estimation as well as follow up estimation after treatment by Steroids for ANCA, C3, C4 \&C5a levels done, measured By ELISA technique.
Methotrexate
Patients in this group will receive:
Methotrexate
* Oral
* At a dosage of 10 to 20 mg/m2/wk (0.35 to 0.65 mg/kg/wk), max dose 25 mg/wk.
* Duration of therapy: 6 - 12 weeks.
Methotrexate
Infants and children with vasculitis attending AssiutU, aged \> 1 mo. - 17 yr. of both genders will be included during 2 years of study.
Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests \& Albumin / creatinine ratio.
All cases will have an initial estimation as well as follow up estimation after treatment by Methotrexate for ANCA, C3, C4 \&C5a levels done, measured By ELISA technique.
Interventions
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Ibuprofen
Infants and children with vasculitis attending AssiutU, aged \> 1 mo. - 17 yr. of both genders will be included during 2 years of study.
Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests \& Albumin / creatinine ratio.
All cases will have an initial estimation as well as follow up estimation after treatment by Ibuprofen for ANCA, C3, C4 \&C5a levels done, measured By ELISA technique.
Prednisone
Infants and children with vasculitis attending AssiutU, aged \> 1 mo. - 17 yr. of both genders will be included during 2 years of study.
Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests \& Albumin / creatinine ratio.
All cases will have an initial estimation as well as follow up estimation after treatment by Steroids for ANCA, C3, C4 \&C5a levels done, measured By ELISA technique.
Methotrexate
Infants and children with vasculitis attending AssiutU, aged \> 1 mo. - 17 yr. of both genders will be included during 2 years of study.
Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests \& Albumin / creatinine ratio.
All cases will have an initial estimation as well as follow up estimation after treatment by Methotrexate for ANCA, C3, C4 \&C5a levels done, measured By ELISA technique.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Month
17 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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RIHassan
Principal investigator
Principal Investigators
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Safiea AF El-Deeb, PROF
Role: STUDY_DIRECTOR
Assiut University Child Hospital
Locations
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Assiut University Pediatric Hospital
Asyut, Upper Egypt, Egypt
Countries
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References
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Chen SF, Wang FM, Li ZY, Yu F, Chen M, Zhao MH. The functional activities of complement factor H are impaired in patients with ANCA-positive vasculitis. Clin Immunol. 2017 Feb;175:41-50. doi: 10.1016/j.clim.2016.11.013. Epub 2016 Dec 6.
Gou SJ, Yuan J, Chen M, Yu F, Zhao MH. Circulating complement activation in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis. Kidney Int. 2013 Jan;83(1):129-37. doi: 10.1038/ki.2012.313. Epub 2012 Aug 22.
Heineke MH, Ballering AV, Jamin A, Ben Mkaddem S, Monteiro RC, Van Egmond M. New insights in the pathogenesis of immunoglobulin A vasculitis (Henoch-Schonlein purpura). Autoimmun Rev. 2017 Dec;16(12):1246-1253. doi: 10.1016/j.autrev.2017.10.009. Epub 2017 Oct 14.
Jarrot PA, Kaplanski G. Pathogenesis of ANCA-associated vasculitis: An update. Autoimmun Rev. 2016 Jul;15(7):704-13. doi: 10.1016/j.autrev.2016.03.007. Epub 2016 Mar 9.
Kallenberg CG, Heeringa P. Complement is crucial in the pathogenesis of ANCA-associated vasculitis. Kidney Int. 2013 Jan;83(1):16-8. doi: 10.1038/ki.2012.371.
Noone D, Hebert D, Licht C. Pathogenesis and treatment of ANCA-associated vasculitis-a role for complement. Pediatr Nephrol. 2018 Jan;33(1):1-11. doi: 10.1007/s00467-016-3475-5. Epub 2016 Sep 5.
Pipitone N, Salvarani C. The role of infectious agents in the pathogenesis of vasculitis. Best Pract Res Clin Rheumatol. 2008 Oct;22(5):897-911. doi: 10.1016/j.berh.2008.09.009.
von Borstel A, Sanders JS, Rutgers A, Stegeman CA, Heeringa P, Abdulahad WH. Cellular immune regulation in the pathogenesis of ANCA-associated vasculitides. Autoimmun Rev. 2018 Apr;17(4):413-421. doi: 10.1016/j.autrev.2017.12.002. Epub 2018 Feb 9.
Related Links
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Nelson Textbook of Pediatrics Expert Consult, Chapter 161, 1-8.
American College of Rheumatology (ACR) Juvenile Idiopathic Arthritis Guideline Project Plan - June 2017
Other Identifiers
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ANCA
Identifier Type: -
Identifier Source: org_study_id
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