The Efficacy and Safety of Adalimumab in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage
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| ClinicalTrials.gov Identifier: NCT05015335 |
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Recruitment Status :
Recruiting
First Posted : August 20, 2021
Last Update Posted : November 10, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uveitis, Anterior Adalimumab | Drug: Adalimumab Drug: Methotrexate | Phase 4 |
This is a prospective, single-center, interventional, randomized, non-blinded, controlled clinical trial that will be performed at the Ophthalmology Department, Peking Union Medical College Hospital.
Children with active noninfectious anterior uveitis demonstrating peripheral vascular leakage on UWFFA and meet the selection criteria will be randomly assigned to treatment group or control group.
Both groups will be treated with a predesigned plan for the active inflammation. At one month or when patients' ocular inflammation gets controlled to 0.5+ cell in the anterior chamber, whichever comes later, patients in the treatment group will be given adalimumab subcutaneously at 40mg every 2 weeks, patients in the control group will be given methotrexate10mg orally once a week.
Follow-up visits will be scheduled every two weeks at the run-in period and the first month after randomization, and every month from the second to the sixth month.
The primary endpoint is treatment failure defined as any inflammatory fare with anterior chamber cell count grading increased from 0 to 1.
Secondary endpoints are best corrected visual acuity (BCVA), inflammation parameters (keratic precipitates, vitreous haze grades), extent of vascular leakage, frequency of topical steroid eyedrops, systemic immunosuppressive drug load, and adverse events.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This is a prospective, single-center,open-lablel, interventional, randomizedcontrolled clinical trial that will be performed at the Ophthalmology Department, Peking Union Medical College Hospital. |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Efficacy and Safety of Adalimumab for Inflammatory Flare Prevention in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage Compared With Methotrexate, a RCT Study |
| Actual Study Start Date : | August 19, 2021 |
| Estimated Primary Completion Date : | July 2022 |
| Estimated Study Completion Date : | July 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Adalimumab
Adalimumab administered subcutaneously at 40mg every 2 weeks
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Drug: Adalimumab
ADA 40mg q2w
Other Name: ADA |
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Active Comparator: Methotrexate
Methotrexate given 10mg orally once a week.
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Drug: Methotrexate
MTX 10mg qw
Other Name: MTX |
- Uveitis flare [ Time Frame: At 6 months' follow-up visit ]
Uveitis flare is defined as anterior chamber cell count grading increased from 0 to 1.
The grading method is in accordance with SUN criteria. Anterior chamber cell count was scored according to Standardization of Uveitis Nomenclature (SUN) criteria
- Extent of peripheral vascular leakage [ Time Frame: At 6 months' follow-up visit ]Vascular leakage was quantified based on the method developed by the Angiography Scoring for Uveitis Working Group (ASUWOG), in which vascular leakage in the posterior pole and in each peripheral quadrant was scored 1 if limited and scored 2 if diffuse. Total maximum score will 8 since leakage in the posterior pole will be excluded in this study.
- Keratic precipitates [ Time Frame: At 6 months' follow-up visit ]Keratic precipitates was recorded in a dichotomous method.
- Vitreous haze [ Time Frame: At 6 months' follow-up visit ]Vitreous haze will graded as the same method of anterior chamber cell, the slit lamp will be pushed forward to the vitreous to observe vitreous haze.
- Best corrected visual acuity (BCVA) [ Time Frame: At 6 months' follow-up visit ]BCVA was transformed into logMar form
- Adverse events [ Time Frame: through study completion, an average of 6 months ]Adverse events included the infectious events and laboratory parameter abnormalities.
- frequency of topical steroid eyedrops if any inflammatory flare happens. [ Time Frame: At 6 months' follow-up visit ]Different GCs eye drops are transformed into equivalent 1% prednisolone for analysis.
- Systemic immunomodulatory therapy (sIMT, including GCs and immunosuppressive drugs)load at the 6-month follow-up visit if any inflammatory flare ever happens. [ Time Frame: At 6 months' follow-up visit ]sIMT load is transformed into a quantizable score based on prior studies in uveitis.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 4 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children with noninfectious uveitis aged between 4-16, weight ≥ 30kg.
- Uveitis resistant to well conducted topical steroid therapy for three months, or uveitis resistant to well conducted 0.1% prednisolone twice a day for one month
- Retina peripheral vascular leakage demonstrated by UWFFA at the time of inclusion.
Exclusion Criteria:
- Any contraindication to administration of immunosuppressive therapy (active tuberculosis, immune deficit, opportunistic infection, other severe chronic disease).
- Previous diagnosis or signs of demyelinating disease of the central nervous system.
- Children unable to cooperate with examinations and follow-up.
- Positive allergy skin test when conducting fluorescence fundus angiography.
- Diffuse vascular leakage, macula edema or any retina lesions demonstrated by UWFFA.
- History of oral immunosuppressive drug treatment within 2 months
- History of biological treatment within 2 months
- History of triamcinolone acetonide subconjunctival/intraocular injection within 3 months
- Current topical steroid use more than six times per day
- History of eye surgery within 3 months.
- Eye complications that interfere with fundus observation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05015335
| Contact: Hang Song, MD | +86 15600612346 | songhang_pumch@163.com | |
| Contact: Meifen Zhang, MD | +86 13681566748 | meifen_zhang@hotmail.com |
| China | |
| Peking University Medical College Hospital | Recruiting |
| Beijing, China, 100000 | |
| Contact: Hang Hang, MD +15600612346 songhang_pumch@163.com | |
| Principal Investigator: | Meifen Zhang, MD | Peking Union Medical College Hospital |
Other Publications:
| Responsible Party: | Peking Union Medical College Hospital |
| ClinicalTrials.gov Identifier: | NCT05015335 |
| Other Study ID Numbers: |
25-ZS-3062 |
| First Posted: | August 20, 2021 Key Record Dates |
| Last Update Posted: | November 10, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | If other researcher needs the IPD. Please contact songhang_pumch@163.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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pheripheral retinal vasuclar leakage adalimumab methotrexate |
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Uveitis Uveitis, Anterior Uveal Diseases Eye Diseases Panuveitis Adalimumab Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents |