UveitisNCT05683626
Safety and Efficacy of Adalimumab Therapy for Treatment of Behcet's Disease-related Uveitis in Sohag University Hospital
An observational study of Uveitis, run by Sohag University at 1 site in Egypt.
Trial summary
the goal of this prospective cohort study is to asses the Safety and efficacy of Adalimumab therapy for treatment of Behcet's disease-related uveitis in adult patients at sohag university hospital. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Uveitis
- What is being tested?
- Humira
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 30 Dec 2023
- How long will I take part?
- 1 Year
- 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 18 to 40 years
- All sexes
- Adult
Study population: 40 eyes of adult patients with complete Behçet's disease associated uveitis either male or female will be included in the study. Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug. Patients will start adose of systemic corticosteroids (methylprednisolone 1mg/kg/day) ,it will be tapered based on clinical improvement of uveitis and systemic symptoms of behcet disease. Also In case of anterior uveitis, topical prednisolone acetate 1% every hour and topical cyclopentolate hydrochloride 1% two or five times per day were prescribed. If it was necessary, pulse corticosteroid therapy was used (1 g/day, for 3-5 days) for severe uveitic attacks.
Who may be able to join
- Adult patients with complete Behçet's disease associated uveitis .
Who cannot join
- Any patient with HIV, HBV, HCV, syphilis, toxoplasma, tuberculosis or other infections; liver, renal, cardiac or demyelinating diseases as well as substance abuse and malignancies will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university
Sohag, 82511
Magdy M Amin, professor, 0934602963, portal@med.sohag.evu.eg
About this study
the goal of this prospective cohort study is to asses the Safety and efficacy of Adalimumab therapy for treatment of Behcet's disease-related uveitis in adult patients at sohag university hospital.
Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug.
Read the detailed description
Study design: Prospective cohort study. Sample size: 40 eyes of adult patients with complete Behçet's disease associated uveitis either male or female will be included in the study.
- Inclusion Criteria: Adult patients with complete Behçet's disease associated uveitis . BD was diagnosed according to the classification criteria for BD proposed by the International Study Group for Behçet Disease .
- Exclusion Criteria: Any patient with HIV, HBV, HCV, syphilis, toxoplasma, tuberculosis or other infections; liver, renal, cardiac or demyelinating diseases as well as substance abuse and malignancies will be excluded from the study
- Treatment plan:
Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug.
Patients will start adose of systemic corticosteroids (methylprednisolone 1mg/kg/day) ,it will be tapered based on clinical improvement of uveitis and systemic symptoms of behcet disease.
Also In case of anterior uveitis, topical prednisolone acetate 1% every hour and topical cyclopentolate hydrochloride 1% two or five times per day were prescribed. If it was necessary, pulse corticosteroid therapy was used (1 g/day, for 3-5 days) for severe uveitic attacks.
Evaluation:
All patients will be evaluated by a safety monitoring board including both ophthalmologist and a rheumatolgist who will be acknowledge in the acknowledgment section later on.
Follow up schedule ; 1st month, 3rd month and 6th month or in case of necessity (relapse or safety concerns).
Full ophthalmological examination will be done for all patients include;
- slit lamp biomicroscopy.
- VA testing (uncorrected and best corrected visual acuity)
- intraocular pressure measurement.
- fundus examination..
- ocular coherence tomography.
- flourescene angiography. Clinical data regarding BCVA, anterior chamber cells and vitreous cells will be collected at baseline ,3 month and at the end of follow-up; OCT will be performed at the start of therapy, at 3- and 6-month follow-up visit and whenever an ocular flare will be suspected.
FA will be performed at the start of therapy and at the end of follow up period.
The diagnosis of macular edema and vasculitis will be based on clinical, OCT, and angiographic findings.
- Conditions
- Uveitis
- Being tested
- Humira
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumiraDrug
subcutaneous injection
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
best corrected visual acuity
Measured: 1 year
Secondary outcomes (2)
AC cells
anterior chamber cells
Measured: 1 year
vitreous haze
vitreous haze
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start15 Dec 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervat Zidan Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683626
- Sponsor's protocol ID
- MZMahmoud
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Adalimumab Therapy for Treatment of Behcet's Disease-related Uveitis in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05683626
- Acronym / sponsor ID
- MZMahmoud
- Conditions
- Uveitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Jan 2023 (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.
the goal of this prospective cohort study is to asses the Safety and efficacy of Adalimumab therapy for treatment of Behcet's disease-related uveitis in adult patients at sohag university hospital.
Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug.
Detailed description
Study design: Prospective cohort study. Sample size: 40 eyes of adult patients with complete Behçet's disease associated uveitis either male or female will be included in the study.
- Inclusion Criteria: Adult patients with complete Behçet's disease associated uveitis . BD was diagnosed according to the classification criteria for BD proposed by the International Study Group for Behçet Disease .
- Exclusion Criteria: Any patient with HIV, HBV, HCV, syphilis, toxoplasma, tuberculosis or other infections; liver, renal, cardiac or demyelinating diseases as well as substance abuse and malignancies will be excluded from the study
- Treatment plan:
Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug.
Patients will start adose of systemic corticosteroids (methylprednisolone 1mg/kg/day) ,it will be tapered based on clinical improvement of uveitis and systemic symptoms of behcet disease.
Also In case of anterior uveitis, topical prednisolone acetate 1% every hour and topical cyclopentolate hydrochloride 1% two or five times per day were prescribed. If it was necessary, pulse corticosteroid therapy was used (1 g/day, for 3-5 days) for severe uveitic attacks.
Evaluation:
All patients will be evaluated by a safety monitoring board including both ophthalmologist and a rheumatolgist who will be acknowledge in the acknowledgment section later on.
Follow up schedule ; 1st month, 3rd month and 6th month or in case of necessity (relapse or safety concerns).
Full ophthalmological examination will be done for all patients include;
- slit lamp biomicroscopy.
- VA testing (uncorrected and best corrected visual acuity)
- intraocular pressure measurement.
- fundus examination..
- ocular coherence tomography.
- flourescene angiography. Clinical data regarding BCVA, anterior chamber cells and vitreous cells will be collected at baseline ,3 month and at the end of follow-up; OCT will be performed at the start of therapy, at 3- and 6-month follow-up visit and whenever an ocular flare will be suspected.
FA will be performed at the start of therapy and at the end of follow up period.
The diagnosis of macular edema and vasculitis will be based on clinical, OCT, and angiographic findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- 40 eyes of adult patients with complete Behçet's disease associated uveitis either male or female will be included in the study. Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug. Patients will start adose of systemic corticosteroids (methylprednisolone 1mg/kg/day) ,it will be tapered based on clinical improvement of uveitis and systemic symptoms of behcet disease. Also In case of anterior uveitis, topical prednisolone acetate 1% every hour and topical cyclopentolate hydrochloride 1% two or five times per day were prescribed. If it was necessary, pulse corticosteroid therapy was used (1 g/day, for 3-5 days) for severe uveitic attacks.
Key inclusion criteria (1 listed)
- Adult patients with complete Behçet's disease associated uveitis .
Key exclusion criteria (1 listed)
- Any patient with HIV, HBV, HCV, syphilis, toxoplasma, tuberculosis or other infections; liver, renal, cardiac or demyelinating diseases as well as substance abuse and malignancies will be excluded from the study
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 |
|---|---|---|
| Humirasubcutaneous injection | Drug | – |
Primary outcome
BCVA
Time frame: 1 year
best corrected visual acuity
2 secondary outcomes
AC cells
Time frame: 1 year
vitreous haze
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by Sohag University at 1 site in Egypt.
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 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: 1 year). 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 13 Jan 2023.