| CTRI Number |
CTRI/2025/11/097093 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Relapse Rate and Disease Severity among patients with Type 2 Lepra Reaction receiving Tofacitinib and Thalidomide separately as an adjuvant to systemic steroids: A Longitudinal Analytical Study |
|
Scientific Title of Study
|
Comparison of Relapse Rate and Disease Severity among patients with Type 2 Lepra Reaction receiving Tofacitinib and Thalidomide separately as an adjuvant to systemic steroids: A Longitudinal Analytical 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 |
Rishav Sanghai |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Dermatology
AIIMS Patna
AIIMS Road
Phulwari Sarif
Patna
Patna
BIHAR
801507
India |
| Phone |
9002013551 |
| Fax |
|
| Email |
rishav.sanghai21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swetalina Pradhan |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
AIIMS Patna |
| Address |
Department of Dermatology
AIIMS Patna
Room No - 409
AIIMS Road
Phulwari Sarif
Patna
Patna
BIHAR
801507
India |
| Phone |
7978843633 |
| Fax |
|
| Email |
dr.swetalinapradhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rishav Sanghai |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Department of Dermatology
AIIMS Patna
AIIMS Road
Phulwari Sarif
Patna
Patna
BIHAR
801507
India |
| Phone |
9002013551 |
| Fax |
|
| Email |
rishav.sanghai21@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
AIIMS Road, Phulwari Sarif |
| 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 |
| Rishav Sanghai |
AIIMS Patna |
Department of Dermatology
AIIMS Road
Phulwari Sarif
Pin-801507
Patna
BIHAR |
9002013551
rishav.sanghai21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A305||Lepromatous leprosy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
: All patients with Type II lepra reaction age more than 18 years who are attending the Department of Dermatology and receiving Tofacitinib as adjuvant to Prednisolone during the study period.
- Patients with Type II lepra reaction age more than 18 years who have received Thalidomide as adjuvant to Prednisolone previously in 2022-23 as available in our department register will also be included in comparison group.
|
|
| ExclusionCriteria |
| Details |
Patients having any active infection or URTI or Diarrhea
Immunocompromised status like HIV/Chemotherapy/Radiotherapy
Breastfeeding women
Severe liver disease or Renal Disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relapse Rate
ENL severity score comparison |
At Baseline, 1 month, 3 month and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse events
DLQI |
At Baseline, 1 month, 3 month and 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/11/2025 |
| 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="0"
Months="6"
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
|
This observational longitudinal analytical study aims to compare the relapse rate and disease severity among patients with Type 2 Lepra Reaction (Erythema Nodosum Leprosum) receiving Tofacitinib versus Thalidomide as adjuvants to systemic corticosteroids (Prednisolone). Patients receiving Tofacitinib during the study period will be prospectively followed for six months and compared with historical data of patients who received Thalidomide during 2022–23 from departmental records. Outcomes will include relapse rate, ENLIST ENL Severity Score (EESS), Dermatology Life Quality Index (DLQI), and adverse events at 1, 3, and 6 months. The study seeks to evaluate whether Tofacitinib, a JAK inhibitor, provides better disease control, lower steroid dependency, and improved quality of life with fewer adverse effects compared to Thalidomide in managing Type 2 Lepra Reaction. |