| CTRI Number |
CTRI/2024/03/063624 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is a study to compare the effectiveness and safety of oral and injectable steroids in systemic lupus erythematosus |
|
Scientific Title of Study
|
A randomized open label trial comparing the efficacy and safety of oral Prednisolone versus intravenous
Methylprednisolone pulse therapy in Systemic Lupus Erythematosus. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asritha C V V |
| Designation |
Post Graduate |
| Affiliation |
IMS and SUM Hospital |
| Address |
Post Graduate,Department of DVL, Department of DVL, IMS and SUM Hospital, Bhubaneshwar
Khordha
ORISSA
751003
India |
| Phone |
7904072348 |
| Fax |
|
| Email |
asrithachintha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maitreyee Panda |
| Designation |
Professor , Dept of DVL |
| Affiliation |
IMS and SUM Hospital |
| Address |
Professor, Department of DVL, Ground Floor, IMS and SUM Hospital, K8 Kalinga Nagar, Bhubaneshwar
Khordha
ORISSA
751003
India |
| Phone |
7904072348 |
| Fax |
|
| Email |
pandamaitreyee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asritha C V V |
| Designation |
Post Graduate |
| Affiliation |
IMS and SUM Hospital |
| Address |
Post Graduate, Department of DVL, Department of DVL, IMS and SUM Hospital, Bhubaneshwar
Khordha
ORISSA
751003
India |
| Phone |
7904072348 |
| Fax |
|
| Email |
asrithachintha@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM hospital, Kalinga Nagar, Bhubaneshwar, 751003 |
|
|
Primary Sponsor
|
| Name |
IMS and SUM Hospital |
| Address |
IMS and SUM Hospital, Kalinga Nagar, Bhubaneshwar, 751003 |
| 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 Asritha C V V |
IMS and SUM Hospital |
Department of DVL, IMS and SUM Hospital, K8 Kalinga Nagar, Bhubaneshwar
Khordha
ORISSA |
7904072348
asrithachintha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, IMS and SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M329||Systemic lupus erythematosus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Methylpredsinolone pulse |
Systemic corticosteroids are considered as mainstay of therapy in SLE
patients owing to their anti-inflammatory and immunosuppressive
properties. Intravenous Methylprednisolone is given 3 days continuously at a dose of 500mg/day in 500 ml NS every month till there is improvement. (minimum of 4 months) |
| Intervention |
Oral Prednisolone |
Systemic corticosteroids are considered as mainstay of therapy in SLE
patients owing to their anti-inflammatory and immunosuppressive
properties. Therapy will be started with 1 mg/kg bwt orally once daily after breakfast till lesions subside maximum of 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years and above with SLEDAI score more than 10 fulfilling the EULAR criteria |
|
| ExclusionCriteria |
| Details |
1. Patients on any treatment within last 3 months
2. Patients having features of other connective tissue diseases
3. Patients with other autoimmune conditions
4. Patients with pre-existing chronic renal failure, previous
malignancy, and liver dysfunction, within six months prior
to randomization.
5. Patients with previously documented severe toxicity to
immunosuppressive drugs.
6. Patients with active acute or chronic infections.
7. Pregnancy and lactation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical assessment
SLAM-R score
Routine investigations (Complete Blood count, Liver function tests, Renal function tests, Urine routine microscopy) |
At Week 4, 8, 12, 16, 20, and 24. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects due to the drugs if any |
At the end of 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Baseline screening: Informed consent will be taken All demographic details like age, gender, and date of birth will be collected as per the data collection form. General Medical History Confirmation of the disease using ACR/EULAR criteria and measuring disease activity using SLEDAI-2K. Monitoring the disease activity at every visit using SLAM-R and CLASI score. Prior/Concomitant treatments Complete physical examination and vital Signs: Blood pressure, pulse rate, and temperature Laboratory testing: Complete Blood Count, Renal Function Tests, Liver Function Tests, Serum Electrolytes, Urine Analysis, 24-hour urine protein, Serology for HIV HBsAg HCV, ESR, CRP, ANA titre and ANA profile. Follow up visits: · After the screening, randomization, and treatment initiation (Week 0), Patients will return for assessments at Weeks 4, 8, 12, 16, 20, and 24. · Collection of data as per data collection form. · Complete physical examination and monitoring of adverse events at every visit. · Calculation of SLAM R score and CLASI score at every visit. · Lab investigations: Complete Blood Count, Renal Function Tests, Liver Function Tests, Urine Analysis at every visit. |