Autoimmune UveitisNCT03886233
Treatment Outcome of Uveitis in Autoimmune Diseases
An observational study of Autoimmune Uveitis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Uveitis
- What is being tested?
- Corticosteroid Series
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Mar 2019to Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include uveitis caused by autoimmune diseases. Uveitis can be anterior (including iritis or iridocyclitis). Intermediate uveitis or vitritis involves the vitreous cavity and may involve the pars plana. Finally, posterior uveitis is divided in three types: choroiditis, retinochoroiditis, and chorioretinitis. In diffuse involvement or when uveitis affects many areas, it is described as panuveitis.
Who may be able to join
- Uveitis with clinical features of autoimmune disease;
Who cannot join
- Other infectious and non-infectious uveitic etiologies that may mimic the given clinical presentation of autoimmune uveitis;
Trial locations and contacts
No sites are listed yet.
About this study
reviewing the outcomes of patients with uveitis caused by autoimmune diseases treated at Assiut University Hospital at the Ophthalmology and Rheumatology and Rehabilitation Departments.
Read the 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
- Being tested
- Corticosteroid Series
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid SeriesDrug
Also called Immunosuppressive drugs, Biological therapy
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Corticosteroid Series | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination the best method for treatment of autoimmune uveitis
compare the rates of treatment failure in the management of autoimmune uveitis between patients who received steroids, immunosuppressive drugs or biological therapies.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study startMar 2019 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune UveitisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham youssif Ahmed Ali, Assiut University
- Investigators
- Hasan L Fahmy, Prof., Study chair, Assiut UniversityMohamed G Saleh, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886233
- Sponsor's protocol ID
- IRB000188
- Status last verified
- Mar 2019
- First submitted
- 20 Mar 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome of Uveitis in Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT03886233
- Acronym / sponsor ID
- IRB000188
- Conditions
- Autoimmune Uveitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 22 Mar 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Treatment for Autoimmune uveitis | – | Drug: Corticosteroid SeriesCorticosteroids 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include uveitis caused by autoimmune diseases. Uveitis can be anterior (including iritis or iridocyclitis). Intermediate uveitis or vitritis involves the vitreous cavity and may involve the pars plana. Finally, posterior uveitis is divided in three types: choroiditis, retinochoroiditis, and chorioretinitis. In diffuse involvement or when uveitis affects many areas, it is described as panuveitis.
Key inclusion criteria (1 listed)
- Uveitis with clinical features of autoimmune disease;
Key exclusion criteria (1 listed)
- Other infectious and non-infectious uveitic etiologies that may mimic the given clinical presentation of autoimmune uveitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid SeriesAlso: Immunosuppressive drugs, Biological therapyimmunosuppressives 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). | Drug | Traditional Treatment for Autoimmune uveitis |
Primary outcome
determination the best method for treatment of autoimmune uveitis
Time frame: 2 years
compare the rates of treatment failure in the management of autoimmune uveitis between patients who received steroids, immunosuppressive drugs or biological therapies.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
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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.
Hasan L Fahmy, Prof. study chair
Assiut University
Mohamed G Saleh, lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Uveitis, 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 1 inclusion and 1 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 22 Mar 2019. 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 Elham Y Ahmed, Bachelor (01144710803, elhamyoussef06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination the best method for treatment of autoimmune uveitis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2019.