| CTRI Number |
CTRI/2022/03/041073 [Registered on: 14/03/2022] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Open label, prospective, non-comparative, multicentric, phase IV clinical study of Iguratimod tablets 25 mg |
|
Scientific Title of Study
|
An open label, prospective, non-comparative, multicentric, phase IV clinical study to evaluate the safety, tolerability and efficacy of Iguratimod tablets 25 mg in patients with active Rheumatoid Arthritis |
| Trial Acronym |
Phase III |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dnyaneshwar Halnor |
| Designation |
Principal Investigator |
| Affiliation |
Family Care Hospital |
| Address |
PK Road, Seven Square Academy, Mira Road (E), Thane-401303
Thane
MAHARASHTRA
401303
India |
| Phone |
7507779219 |
| Fax |
|
| Email |
drdnyaneshwarhalnorvvh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mote |
| Designation |
Director |
| Affiliation |
Mediclin Clinical Research |
| Address |
Mediclin Clinical Research, Fourth Floor, Ambika Industries, Penkar Pada, Opposite Thakur Mall, Mira Road (E), Thane-401 107, India
Mumbai (Suburban)
MAHARASHTRA
401107
India |
| Phone |
|
| Fax |
|
| Email |
ravindra.mote@mediclincr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Mote |
| Designation |
Director |
| Affiliation |
Mediclin Clinical Research |
| Address |
Mediclin Clinical Research, Fourth Floor, Ambika Industries, Penkar Pada, Opposite Thakur Mall, Mira Road (E), Thane-401 107, India
Mumbai (Suburban)
MAHARASHTRA
401107
India |
| Phone |
|
| Fax |
|
| Email |
ravindra.mote@mediclincr.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Limited |
| Address |
Plot No. 43 AB & 44 BCD,
Govt. Industrial Estate,
Charkop, Kandivali (W),
Mumbai – 400 067
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nilesh Kumar |
Banaras Hindu University (BHU), |
Banaras Hindu University, Ajagara, Varanasi, Uttar Pradesh-221005.
Varanasi
UTTAR PRADESH |
9889655100
nilesh19arreno@gmail.com |
| Dr Nilesh Nolkha |
Care and Cure Hospital |
Care and Cure Hospital,Kaamdhenu Apartment, Achole Road,Nallasopara East
Mumbai
MAHARASHTRA |
9920355665
drnileshnolkha@yahoo.com |
| Dr Diptak Bhowmik |
College of Medicine & Sagore Dutta Hospital |
College of Medicine & Sagore Dutta Hospital, 578 B. T. Road, Kamarhati, Kolkata - 700058, West Bengal
Kolkata
WEST BENGAL |
8777047635
diptak86@gmail.com |
| Dr Sunil Naik |
Govt Medical College and Govt General Hospital (Old RIMSGGH) |
Dept of Medicine, Govt Medical College and Govt General Hospital (Old RIMSGGH),Srikakulam,532001,Andrapradesh India
Srikakulam
ANDHRA PRADESH |
8942279033
drsunilnaikggh@gmail.com |
| Dr Rajendra Kumar Verma |
GSVM |
GSVM, Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH |
7839261937
Drrkverma.research@gmail.com |
| Dr Anil Samaria |
JLN Kalabaug Ajmer |
JLN Kalabaug Ajmer Rajasthan.
Ajmer
RAJASTHAN |
8118877284
Dr.anilsamaria@outlook.com |
| Dr Angan Karmakar |
Nil Ratan Sircar Medical College and Hospital |
Nil Ratan Sircar Medical College and Hospital, 138, Acharya Jagdish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal-700014.
Kolkata
WEST BENGAL |
9836745965
docangan88@gmail.com |
| Dr Giri Raja KV |
Rajalakshmi Hospital & Research Center |
Rajalakshmi Hospital & Research Center, 21/1, Lakshmipura Main Road, Vidyaranyapura Post, Lakshmipura, Bengaluru, Karnataka 560097
Bangalore
KARNATAKA |
9448039952
drgirirajakv@gmail.com |
| Dr Urvi Patel |
Shivam Orthopedic and Medical Hospital |
Shivam Orthopedic and Medical Hospital Site,2nd Floor, Aishwarya Complex, 202, Jawahar Chowk, Opp. Shell Petrol Pump, Uttamnagar, Daxini Society, Maninagar, Ahmedabad, Gujarat 380008
Ahmadabad
GUJARAT |
7820874653
drurvipatel3@gmail.com |
| Dr Prashant Walke |
Swara Hospital |
Swara Hospital, 1st Floor, Apollo Shopping Centre, Agashi Road, Virar West, Palghar-401303.
Mumbai (Suburban)
MAHARASHTRA |
9860844434
prashantwalke18@gmail.com |
| Dr Sameer Agarwal |
Tulsi Hospital |
Tulsi Hospital Pvt Ltd Civil Line Kanpur
Kanpur Nagar
UTTAR PRADESH |
8175910410
agarwalsameer66@gmail.com |
| DrUmarji Pramod Bhimrao |
Umarji Mother and Child Care |
Umarji Mother and Child Care,Pune
Pune
MAHARASHTRA |
9822307068
pramod.umarji@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee-CIEC |
Approved |
| Ethicare Ethics Committee |
Approved |
| Ethics Committee GSVM Medical College |
Approved |
| Ethics Committee, N.R.S. Medical College, |
Approved |
| Institutional Ethics Committee College of Medicine and Sagore Dutta Hospital |
Approved |
| Institutional Ethics Committee government medical college and hospital Srikakulum |
Approved |
| Institutional Ethics Committee Institute of Medical Sciences Banaras Hindu University |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
| Riddhi Medical Nursing Home IEC |
Approved |
| Shah Lifeline Hospital and Heart Institute Ethics Committee |
Approved |
| Tulsi Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged between 18 and 75 years (both inclusive).
2. Patients who are on stable maximum tolerable dose of MTX and /OR other conventional DMARD’s since last 4 weeks.
3. Patients having a DAS28 score ≥ 3.2 at baseline.
4. Patients with ability to understand and provide written informed consent, which must have been obtained prior to screening.
5. Patients willing to comply with the protocol requirements.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are hypersensitive to Iguratimod or any of its components.
2. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
3. Females who are not ready to use acceptable contraceptive methods during the course of the study.
4. Patients who are on Biologicals for the treatment of RA.
5. Patients with elevated liver enzymes (SGPT, SGOT) and clinically significant impaired hepatic function.
6. Patients with bone marrow hypoplasia. (WBC<3,500/mm3 or absolute PMNs < 1500/mm3 or platelet count <150,000/mm3)
7. Patients with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2.
8. Patients with known case of clinically significant psychiatric disease, cerebrovascular disease, cardiovascular disease, gastrointestinal disease, infective or any acute or chronic uncontrolled systemic diseases that may affect patient safety.
9. Patients with history of drug or substance (alcohol/drug) abuse within previous 1 year.
10. Patients with medical history of oncological conditions since last 5 years.
11. Patients with concurrent participation in another clinical trial within 90 days prior to signing informed consent form.
12. Patients with suspected inability or unwillingness to comply with the study procedures.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of patients reporting incidences of AE during the study and their assessment with respect to intensity, duration, pattern and causal relationship to the study medication.
• Proportion of patients reporting incidences of SAE during the study and their assessment with respect to intensity, duration, pattern and causal relationship to the study medication.
• Changes in laboratory safety parameters from baseline to end of the study.
|
Adverse events, SAE or abnormal lab values |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of patients meeting the American College of Rheumatology 20% and 50% (ACR20 and ACR50) response criteria at the end of the study.
• Mean reduction in DAS 28 at the end of the study.
Change in mean VAS score for pain assessment from baseline to end of the study visit. |
Week 24 |
|
|
Target Sample Size
|
Total Sample Size="334"
Sample Size from India="334"
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)
|
15/03/2022 |
| 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="2"
Months="6"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
An open label, prospective, non-comparative, multicentric, phase IV clinical study to evaluate the safety, tolerability and efficacy of Iguratimod tablets 25 mg in patients with active Rheumatoid Arthritis |