| CTRI Number |
CTRI/2024/05/067140 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to compare the effectiveness and safety of iguratimod with methotrexate in rheumatoid arthritis patients |
|
Scientific Title of Study
|
Determining the effectiveness and safety of iguratimod with the background therapy of methotrexate in the rheumatoid arthritis Patients: a randomized double blinded placebo-controlled 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 |
Midhun Sakravarthy J |
| Designation |
Junior Resident |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Pharmacology, 4th floor, Academic Block, ESIC
Medical college and Hospital, Sanathnagar
Hyderabad TELANGANA 500038 India |
| Phone |
8220473742 |
| Fax |
|
| Email |
dr.midhunsakravarthy916@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Seethalakshmi S |
| Designation |
Director-Professor and Head of Department Pharmacology |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Pharmacology, 4th floor, Academic Block, ESIC
Medical college and Hospital, Sanathnagar
Hyderabad TELANGANA 500038 India |
| Phone |
6369702539 |
| Fax |
|
| Email |
seethapharmacology@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mehdi Ali Mirza |
| Designation |
Assistant Professor Pharmacology |
| Affiliation |
ESIC Medical College and Hospital |
| Address |
Department of Pharmacology, 4th floor, Academic Block, ESIC
Medical college and Hospital, Sanathnagar
Hyderabad TELANGANA 500038 India |
| Phone |
9160368850 |
| Fax |
|
| Email |
mehdialimirza@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Midhun Sakravarthy J |
| Address |
Department of Pharmacology, 4th floor, Academic Block, ESIC Medical college and Hospital, Sanathnagar, Hyderabad |
| Type of Sponsor |
Other [Self] |
|
|
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 Midhun Sakravarthy J |
ESIC Medical College and Hospital |
Department of
Rheumatology, 4th floor,
OPD building,
ESIC Medical College and
Hospital, Sanath Nagar Hyderabad TELANGANA |
8220473742
dr.midhunsakravarthy916@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, ESIC Medical College & Hospital and ESIC Super Specialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
METHOTREAXTE plus PLACEBO |
METHOTREXATE standard dose, once a week for 6 months plus identical looking placebo twice daily for 6 months |
| Intervention |
METHOTREXATE plus IGURATIMOD |
METHOTREXATE standard dose once a week for 6 months plus IGURATIMOD 25mg, twice daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged 18 years to 65 years
2. Patients of either gender
3. Patients who are newly diagnosed with Seropositive Rheumatoid arthritis according to ACR-EULAR 2010 Criteria (≥6 – Definite RA) with duration of less than one year and Disease Activity Score ≥3.2 |
|
| ExclusionCriteria |
| Details |
1. Impaired hepatic Function with elevated AST or ALT levels ≥ 3 times the upper limit of normal
2. Patient with history of renal disease or impaired kidney function with elevated Serum creatinine
3. Pregnant and lactating women.
4. Known malignancies
5. Known Hepatitis B, C and HIV patients
6. Other Auto-immune diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in DAS-28 ESR score |
0, 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Hgb, Total WBC, Platelets count, Serum Creatinine, ALT, AST
2. Adverse reactions
3. Change in ESR, CRP levels
4. ACR 20/50/70 |
1.0 and every 4 weeks upto 24 weeks
2. 0 and every 4 weeks upto 24 weeks
3. 0, 12th week, 24th week
4. 12th week and 24th week |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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 4 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="6" 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
|
Rheumatoid arthritis (RA) is an autoimmune inflammatory disease primarily characterized by synovitis. It causes pain, swelling, and stiffness of multiple joints and leads to joint destruction. It can be progressed rapidly after onset, resulting in irreversible physical dysfunction and deformation of the affected joints. Worldwide 18 million people (prevalence 0.46% of global population) are living with RA and around 70% are women and 55% of them are from postmenopausal age group. In India, the prevalence of RA is estimated to be 0.7%. Most commonly the diagnosis is made through American College of Rheumatology – European alliance of Associations for Rhuematology (ACR-EULAR) 2010 Criteria. That is based on Joints involvement, serology, acute phase reactants and duration of symptoms. A score of 6 or more out of a possible maximum of 10 constitutes a classification of ‘definite’ RA. The first line treatment starts with Methotrexate (MTX), a Conventional Synthetic Disease Modifying Anti-Rheumatic Drug (csDMARDs) used as monotherapy or in combinations with other drugs. Iguratimod (IGU) is a new small molecule, an immunomodulator, inhibiting T and B-cell differentiation, reducing inflammation. It was approved in China (2011), Japan (2012) and more recently in India in 2019. The present study is planned to determine the effectiveness and safety of IGU in comparison with placebo as add on to MTX in RA patients.
|