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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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