Treatment Outcome of Uveitis in Autoimmune Diseases

NCT ID: NCT03886233

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-31
• Study Completion Date: 2021-02-28

Brief Summary

reviewing the outcomes of patients with uveitis caused by autoimmune diseases treated at Assiut University Hospital at the Ophthalmology and Rheumatology and Rehabilitation Departments.

Detailed Description

Autoimmune uveitis (AU) is an inflammation of the uvea caused by either an autoimmune reaction to self-antigens or an innate inflammatory reaction secondary to an external stimulus. Corticosteroids are considered the gold standard in management of acute AU, but it is necessary to combine them with other immunosuppressive drugs. Finally, biological anti-inflammatory agents (for exapmle antagonists of tumor necrosis factor alpha like Infliximab and adalimumab) are also showing very promising results. Follow-up visits of subjects with uveitis must be frequent and focused on monitoring the recurrence of acute outbreaks, , if any. They should be aimed to determine the evolution of inflammatory signs until their complete resolution, thus ensuring the least possible consequences. After the initial phase of the treatment, the duration of use of the maintenance medication is directly related to the diagnosis, treatment and control of the underlying disease. This will help to determine if a patient is badly controlled and requires a more aggressive therapeutic plan. Also, a complete physical exam must be done each time the patient sees to the physician in order to monitor ophthalmological complications or development of adverse effects secondary to the treatment.

Conditions

Autoimmune Uveitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Traditional Treatment for Autoimmune uveitis

Corticosteroids are considered the gold standard in management of acute AU. They can only be administered after excluding infectious origin. Their use for prolonged time and/ or in high doses may be associated with serious adverse events . Therefore, it is necessary to combine them with other immunosuppressive drugs.Based on their mechanism of action, immunosuppressives are divided into alkylating agents (cyclophosphamide and chlorambucil), antimetabolites (methotrexate, azathioprine, and Mycophenolate Mofetil), and calcineurin inhibitors (cyclosporine, tacrolimus and sirolimus).Dosage form, dosage, frequency and duration differ according to age and case severity.

Corticosteroid Series

Intervention Type: DRUG

immunosuppressives are divided into alkylating agents (cyclophosphamide and chlorambucil), antimetabolites (methotrexate, azathioprine, and Mycophenolate Mofetil), and calcineurin inhibitors (cyclosporine, tacrolimus and sirolimus) Biological anti-inflammatory agents (for exapmle antagonists of tumor necrosis factor alpha like Infliximab and adalimumab).

Biological Treatment for Autoimmune uveitis

Biological anti-inflammatory agents (for exapmle antagonists of tumor necrosis factor alpha like Infliximab and adalimumab) are also showing very promising results. In many cases, these agents will be seen listed as first choice in some autoimmune diseases, depending on the patient's history, age, sex, type and severity of the inflammatory disease.

No interventions assigned to this group

Interventions

Corticosteroid Series

immunosuppressives are divided into alkylating agents (cyclophosphamide and chlorambucil), antimetabolites (methotrexate, azathioprine, and Mycophenolate Mofetil), and calcineurin inhibitors (cyclosporine, tacrolimus and sirolimus) Biological anti-inflammatory agents (for exapmle antagonists of tumor necrosis factor alpha like Infliximab and adalimumab).

Intervention Type: DRUG

Other Intervention Names

Immunosuppressive drugs; Biological therapy

Eligibility Criteria

Inclusion Criteria

• Uveitis with clinical features of autoimmune disease;

Exclusion Criteria

• Other infectious and non-infectious uveitic etiologies that may mimic the given clinical presentation of autoimmune uveitis;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Elham youssif Ahmed Ali

Assiut

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hasan L Fahmy, Prof.

Role: STUDY_CHAIR

Assiut University

Mohamed G Saleh, lecturer

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Elham Y Ahmed, Bachelor

Role: CONTACT

elhamyoussef06@gmail.com

01144710803

Other Identifiers

IRB000188

Identifier Type: -

Identifier Source: org_study_id