| CTRI Number |
CTRI/2025/02/080590 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Adalimumab in Non-Infective Uveitis in Adults |
|
Scientific Title of Study
|
Prospective Analysis of Patients on Adalimumab for Non-Infective Uveitis in Adults: A 3-Year Follow-Up Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohan Chawla |
| Designation |
Additional Professor |
| Affiliation |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 |
| Address |
Dr RP Centre for Ophthalmic Sciences
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar, New Delhi 110029
South DELHI 110029 India |
| Phone |
9891052939 |
| Fax |
|
| Email |
dr.rohanrpc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rohan Chawla |
| Designation |
Additional Professor |
| Affiliation |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 |
| Address |
Dr RP Centre for Ophthalmic Sciences
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar, New Delhi 110029
South DELHI 110029 India |
| Phone |
9891052939 |
| Fax |
|
| Email |
dr.rohanrpc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rohan Chawla |
| Designation |
Additional Professor |
| Affiliation |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 |
| Address |
Dr RP Centre for Ophthalmic Sciences
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar, New Delhi 110029
South DELHI 110029 India |
| Phone |
9891052939 |
| Fax |
|
| Email |
dr.rohanrpc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr RP Centre for Ophthalmic Sciences
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
Dr RP Centre for Ophthalmic Sciences
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohan Chawla |
AIIMS, New Delhi |
Dr RP Centre for Ophthalmic Sciences
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar, New Delhi 110029 South DELHI |
9891052939
dr.rohanrpc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institue Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H308||Other chorioretinal inflammations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with NIU requiring systemic treatment
Sight threatening uveitis cases which are started on Adalimumab therapy such as cases of chronic intermediate uveitis, choroiditis, vasculitis, or VKH will be predominantly included.
Both chronic and recurrent cases of above subtypes of uveitis on Adalimumab will be included. Definitions of chronic and recurrent is as per standardized uveitis nomenclature (International).
Unable to maintain remission on 5mg or less prednisolone with or without other immunomodulators
Willingness to receive adalimumab therapy and participate in the study |
|
| ExclusionCriteria |
| Details |
Possible to maintain remission on prednisolone 5 mg or less
Possible to maintain remission on immunomodulators with or without prednisolone in a dose of 5mg or less
Active or uncontrolled systemic infection
Active tuberculosis
Uncontrolled or significant medical conditions (e.g., severe cardiovascular disease, uncontrolled diabetes, active malignancy)
Pregnancy or breastfeeding
History of hypersensitivity to adalimumab or its components
Multiple sclerosis or other demyelinating diseases
Inability or unwillingness to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improved treatment recommendations for patients with inadequate response to conventional therapies.
2. Development of personalized treatment strategies based on individual characteristics and response to adalimumab.
3. Enhanced understanding of the long-term safety profile of adalimumab. |
Baseline: Ophthalmic evaluation (e.g., visual acuity, IOP, anterior chamber cells, vitreous haze, OCT), lab tests, and disease history assessment.
Follow-Up:
1 Month: Initial response and side effects.
3 Months: Short-term efficacy and therapy adjustments.
6 Months: Monitor response and adverse events.
12 Months: Evaluate effectiveness and tolerability.
Years 2-3: Assess long-term outcomes and adherence.
Additional Visits: For flare-ups or complications. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background:Non-infective uveitis is a major cause of vision loss in adults, characterized by inflammation in the eye’s uveal tract, which includes the iris, ciliary body, and choroid. If untreated, it can lead to severe complications like cataracts, glaucoma, macular edema, and permanent vision loss. Traditional treatments, including corticosteroids and immunosuppressive agents, are effective but often come with significant side effects and are not always well-tolerated by patients. Adalimumab, a biologic agent that targets tumor necrosis factor (TNF)-alpha, has shown promise in the treatment of inflammatory conditions, including non-infective uveitis. While previous studies have demonstrated the efficacy of adalimumab in managing non-infective uveitis, there is limited data on its long-term effects and sustained benefits, especially in the Indian population. Purpose of the Trial:The primary objective of this study is to evaluate the effectiveness of adalimumab in the management of non-infective uveitis in adults, with a focus on its ability to control ocular inflammation and maintain remission over a period of 1 year. The trial aims to assess how well adalimumab controls uveitis inflammation, its impact on visual acuity, and its safety profile when used as a long-term treatment option. This study will contribute to better understanding the role of adalimumab in managing chronic uveitis and could potentially offer a more effective and well-tolerated alternative to existing treatments. Additionally, the results may help establish guidelines for its use in clinical practice, particularly in cases of uveitis that are resistant to conventional therapies. |