| CTRI Number |
CTRI/2025/05/087582 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare rituximab standard dose versus low dose for lung disease in systemic sclerosis patients |
|
Scientific Title of Study
|
A randomized controlled trial To compare the efficacy of low dose versus standard dose rituximab in patients with systemic sclerosis interstitial lung disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Basant Kumar Pathak |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Internal Medicine 4th floor, F block Nehru Hospital,
Post Graduate Institute Of Medical Education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7796082098 |
| Fax |
|
| Email |
bkpathak27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shefali Khanna Sharma |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical education and Research, Chandigarh |
| Address |
Department of Internal Medicine 4th floor, F block Nehru Hospital,
Post graduate Institute of Medical education and Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417372439 |
| Fax |
|
| Email |
sharmashefali@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shefali Khanna Sharma |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical education and Research, Chandigarh |
| Address |
Department of Internal Medicine 4th floor, F block Nehru Hospital,
Post graduate Institute of Medical education and Research
CHANDIGARH
160012
India |
| Phone |
9417372439 |
| Fax |
|
| Email |
sharmashefali@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Rheumatology Association, Plot no- 4, Jharkhand Mor, Khatipura Road Jaipur (Rajasthan), PIN - 302012 (India) |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of Internal Medicine 4th floor, F block Nehru Hospital
PGIMER |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Basant kumar Pathak |
Post Graduate Institute of Medical Education and Research Chandigarh |
Department of Internal
Medicine 4th floor, F
block, Nehru Hospital,
Sector 12
Chandigarh
CHANDIGARH |
7796082098
bkpathak27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Commitee, Post Graduate Institute Of Medical Research Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M340||Progressive systemic sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Rituximab low dose |
Rituximab 500 mg will be given twice two weeks apart |
| Intervention |
Rituximab Standard Dose |
Rituximab 1 G IV will be given twice two weeks apart |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with SSc as diagnosed by ACR 2013. Duration of SSc for less than 10 years with onset defined as the appearance of the first non Raynauds symptom. Consenting to participate in the study. FVC of 40 percent or above the standard population, age matched. HRCT chest suggestive of ILD (more than 10 percent of lung parenchyma). |
|
| ExclusionCriteria |
| Details |
Clinically significant abnormality on chest X-ray or HRCT other than ILD changes (for example lung mass, effusion). Pregnant or lactating females. Severe pulmonary arterial hypertension (mPAP more than 55mmHg) requiring drug therapy. Active infection. Active myositis. Prior use of rituximab in the last six months. Positive for Hepatitis B surface antigen or Anti Hepatitis C virus antibody before the baseline visit. Serum creatinine more than 2 mg/dl. Serum ALT or AST more than 2 times ULN. Active malignancy or history of malignancy in the last 5 years
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the change in forced vital capacity
(FVC) (%) in subjects with
systemic sclerosis- Interstitial lung
disease(SSc-ILD) when treated with Rituximab Standard Dose versus Low dose Rituximab |
0 and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Change in modified Rodnan score (mRSS) at 24 weeks 2. Absolute change from baseline in FVC in litres at 24 weeks 3. Change in 6-minute walking distance at 24 weeks 4. To compare the change in Quality of Life (QoL) scores by Medical Outcomes Short Form (SF-36) and dyspnea scores by Mahler Dyspnea index at 24 weeks 5. All-cause mortality at 24 weeks 6. Incidence of adverse effects between the two groups 7. Peripheral B Cell depletion in standard dose versus low dose rituximab assessed by flowcytometry 8. Immunoglobulin profile pre and post treatment in standard dose versus low dose rituximab 9. Change in disease activity as assessed by 18F-FDG PET CT in standard dose versus low dose rituximab. 10. Difference in the cost incurred in the two arms based on Markov model |
0 and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/06/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
is an open label prospective randomised controlled trial. The study will be
carried out on 30 consecutive consenting patients of SSc- ILD, with 15 in Rituximab
low dose arm and 15 in the rituximab standard dose arm. Patients will be recruited
from outpatient department of internal medicine and rheumatology clinic of our
hospital. Patients will be followed up till 24 weeks on an open label basis
subsequently. All patients fulfilling the classification criteria of
scleroderma (ACR/EULAR 2013) during the study period will be screened for the presence
of ILD. The study consists of two treatment arms. One arm will receive rituximab
1g two dosage two weeks apart and the other arm will receive 500 mg two dosage
2 weeks apart. We will be measuring the FVC predicted as the primary objective
at 24 weeks . The secondary objectives will include functional outcomes like
SF-36 questionnaire, Mahlers Dyspnea Index, 6 minute Walk Distance, adverse
effects profile between the groups receiving low dose versus standard dose
rituximab, B cell depletion and serum immunoglobulins. |