| CTRI Number |
CTRI/2025/03/082541 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Adalimumab in Non Infective Uveitic 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 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANJAY KUMAR MISHRA |
| Designation |
Scientist |
| Affiliation |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 |
| Address |
Room No. 145,
Dr. R. P. Centre for Ophthalmic Sciences,
AIIMS,
New Delhi
# 145,
Retina Clinic,
Dr. R. P. Centre for Ophthalmic Sciences,
AIIMS,
New Delhi 110029
South
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SANJAY KUMAR MISHRA |
| Designation |
Scientist |
| Affiliation |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 |
| Address |
Room No. 145,
Dr. R. P. Centre for Ophthalmic Sciences,
AIIMS, New Delhi
# 145, Retina Clinic,
Dr. R. P. Centre for Ophthalmic Sciences,
AIIMS,
New Delhi 110029
South
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SANJAY KUMAR MISHRA |
| Designation |
Scientist |
| Affiliation |
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029 |
| Address |
Room No. 145,
Dr. R. P. Centre for Ophthalmic Sciences,
AIIMS,
New Delhi
# 145, Retina Clinic,
Dr. R. P. Centre for Ophthalmic Sciences,
AIIMS,
New Delhi 110029
South
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Room No. 145, Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS),
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 |
All India Institute of Medical Sciences (AIIMS), New Delhi |
# 145, Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), New Delhi 110029
South
DELHI |
8802105456
sanjaymishraknp@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, 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 |
| Intervention |
Adalimumab 40 mg subcutaneous injection every 2 weeks outcomes in adult non-infective uveitis management 1-year follow-up study |
Adalimumab 40 mg subcutaneous injection every 2 weeks efficacy and safety in adult non-infective uveitis management 1-year follow-up study, including changes in BCVA, anterior chamber inflammation, vitreous haze, macular edema, and adverse events |
| Comparator Agent |
Adalimumab 40 mg subcutaneous injection every 2 weeks vs conventional therapy (systemic corticosteroids, immunosuppressants) in adult non-infective uveitis management 1-year follow-up study outcomes (BCVA, anterior chamber inflammation, vitreous haze, macular edema, adverse events) |
Adalimumab 40 mg subcutaneous injection every 2 weeks vs conventional therapy (systemic corticosteroids, immunosuppressants) in adult non-infective uveitis management 1-year follow-up study; outcomes include change in BCVA (logMAR), anterior chamber inflammation (SUN criteria), vitreous haze (NEI grading), macular edema (OCT), treatment discontinuation rate, adverse events (injection site reactions, infections), and quality of life (NEI-VFQ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age ≥ 18 years
2. Diagnosed with NIU requiring systemic treatment
3. 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.
4. 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).
5. Unable to maintain remission on 5mg or less prednisolone with or without other immunomodulators
6. Willingness to receive adalimumab therapy and participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Possible to maintain remission on prednisolone 5 mg or less
2. Possible to maintain remission on immunomodulators with or without prednisolone in a dose of 5mg or less
3. Active or uncontrolled systemic infection
4. Active tuberculosis
5. Uncontrolled or significant medical conditions (e.g., severe cardiovascular disease, uncontrolled diabetes, active malignancy)
6. Pregnancy or breastfeeding
7. History of hypersensitivity to adalimumab or its components
8. Multiple sclerosis or other demyelinating diseases
9. 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. Efficacy & Safety of Adalimumab in NIU.
2. Sub-group analysis of various parameters.
3. Long-term outcomes of Adalimumab treatment |
1. Participant recruitment: 6 months
2. Intervention and follow-up: 3 years
3. Data analysis and reporting: 6 months
3. Long-term outcomes of Adalimumab treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Visual Acuity Improvement
2.Reduction in Retinal Thickness
3.Incidence of Relapses or Flare-Ups
4.Quality of Life Improvements
5.Steroid-Sparing Effect
6.Adverse Events & Safety Profile
7.Inflammatory Marker Changes: |
Visual Acuity at baseline & follow-ups at 1, 3, 6 months, then every 6 months. Retinal Thickness at baseline & follow-ups at 3, 6, 12, 24, 36 months. Relapses recorded as they occur. Quality of Life at baseline & follow-ups at 6, 12, 24, 36 months. Steroid Sparing at baseline & all visits. Adverse Events continuously monitored. Inflammatory Markers at baseline & follow-ups at 6, 12, 24, 36 months. |
|
|
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)
|
31/03/2025 |
| 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
|
Primary Objectives:
- Efficacy and Safety: Evaluate the effectiveness and
safety of adalimumab. This will be assessed through:
a) Improvement in visual acuity (BCVA)
b) Reduction in disease activity using
standardized criteria
c) Changes in clinical parameters
(anterior chamber flare and cells, vitreous opacity, fundus findings)
Secondary Objectives:
- Subgroup Analysis: Analyze treatment outcomes
based on demographic factors (age, gender) and specific disease
characteristics (e.g., uveitis subtype, rheumatological disease subtypes).
Long-term Outcomes: Assess the durability of treatment effects and
optimize follow-up visit frequency based on disease activity and treatment
response.
Statement of Study Hypothesis: Data
collection and analysis of Indian patients receiving Adalimumab for uveitis.
This therapy is being used in the developed world for a long time now. However,
due to cost constraints it was not used much in India and at AIIMS, New Delhi.
Now, with availability of biosimilars and some funding from an NGO we have
started using this for patients at AIIMS. This study is an attempt to
systematically keep data of such patients for assessing the effectivity and
side effect profile in our patient population.
|