| CTRI Number |
CTRI/2017/07/009079 [Registered on: 19/07/2017] Trial Registered Prospectively |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate Efficacy, Safety and Tolerability of Iguratimod Tablets Vs. Methotrexate Tablets for the treatment of Active Rheumatoid Arthritis. |
|
Scientific Title of Study
|
A Comparative, Two Arm, Randomized, Double Blind, Parallel Group, Multicentric, Non-Inferior Clinical Study to Evaluate Efficacy, Safety and Tolerability of Iguratimod Tablets 25 mg as an add on Therapy over Methotrexate Tablets 15 mg Vs. Methotrexate Tablets 25 mg for the treatment of Patients with Active Rheumatoid Arthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/12/001 |
Protocol Number |
| Version : 03, Date : 28 Jun 2016 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramakrishnam Naidu |
| Designation |
Principal Investigator |
| Affiliation |
King George Hospital |
| Address |
Department of Medicine, Rajendra Prasad Ward, King George Hospital, Maharanipeta, Visakhapatnam-530002.
Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH
530002
India |
| Phone |
9885093386 |
| Fax |
|
| Email |
rammky@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Sr. Vice President R&D and Reg. Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.
Mumbai
MAHARASHTRA
400067
India |
| Phone |
2266062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA. |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.
Mumbai
MAHARASHTRA
400067
India |
| Phone |
2266062111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
|
Source of Monetary or Material Support
|
| Ajanta Pharma Ltd
Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA.
Mumbai
MAHARASHTRA
400067. |
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Ltd |
| Address |
Advent 43AB/44CD Charkop Industrial Estate Kandivli West, Mumbai MAHARASHTRA. Mumbai MAHARASHTRA 400067. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jesalpura Bhavesh Harshdray |
AMCMET Medical College & L. G. General Hospital |
Department of Orthopaedics, Maninagar, Ahmedabad–380006.
Gujarat.
Ahmadabad
GUJARAT |
9033023000
Bjesalpura@yahoo.com |
| Dr Manohar R Joshi |
Dr. D. Y. Patil Hospital and Research Centre |
Sec 5, Nerul, Navi Mumbai-400706
Thane
MAHARASHTRA |
9022777731
drjoshimanohar@gmail.com |
| Dr Sandeep Kharkar |
Ganga Care Hospital |
Department of Rheumatology, 3 Farmland,Panchsheel Square, Wardha Road,Nagpur 440 012, Maharashtra.
Nagpur
MAHARASHTRA |
9370808866
drksandeep@gmail.com |
| Dr Taral Parikh |
GCS Medical College Hospital & Research Centre |
Department of Rheumatology
Opp-DRM office, Near chamunda bridge, Naroda Road, Ahmdabad-380025, Gujarat,
Ahmadabad
GUJARAT |
9428419903
parikhtaralp@gmail.com |
| Dr Rohit Deshpande |
Grant Govt. Medical College & Sir J J Group of Hospitals |
Department of Medical & Clinical Pharmacology, Grant Govt. Medical College & Sir JJ Group of Hospitals (Government of Maharashtra)
Mumbai
MAHARASHTRA |
9096050150
coolrohit258@gmail.com |
| Dr Santosh Kumar |
Indira Gandhi Institute of Medical Sciences |
Orthopaedics Department,
Sheikhpura, Patna-800014,
Bihar, India.
Patna
BIHAR |
9473191824
drsantoshigimsortho@gmail.com |
| Dr Ramakrishnam Naidu |
King George Hospital |
Department of Medicine, Rajendra Prasad Ward, Maharanipeta, Visakhapatnam-530002.
Andhra Pradesh.
Visakhapatnam
ANDHRA PRADESH |
9885093386
rammky@yahoo.com |
| Dr Archana M Uppin |
KLE’s Dr. Prabhakar Kore Hospital and MRC |
Department of Rheumatology
Nehru Nagar, Belagavi- 590010
Belgaum
KARNATAKA |
9844175418
drarchanak85@gmail.com |
| Dr Nilesh Jayawant Patil |
Lifepoint Multispecialty hospital |
145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad,
Pune-411057.
Maharashtra.
Pune
MAHARASHTRA |
9673100066
njp@yahoo.com |
| Dr Alok Kalyani |
Maharaja Agrasen Hospital |
Department of Rheumatology
Punjabi Bagh, New Delhi-110026.
New Delhi
DELHI |
9540946955
alokkalyani@gmail.com |
| Dr Kaushik Basu |
Medical College |
Department of Rheumatology
88, College Street, Kolkata - 700073.
West Bengal
Kolkata
WEST BENGAL |
9038831211
phoenix.0013@gmail.com |
| Dr Shefali K Sharma |
Post graduate Institute of Medical Eduaction & Research |
Deaprtment of Internal Medicine, Sector-12, Chandigrah-160 012
Chandigarh
CHANDIGARH |
9417372439
sharmashefali@hotmail.com |
| Dr Rajendra Kumar Verma |
Postgraduate Department of Medicine G.S.V.M. Medical College |
Postgraduate Department of Medicine G.S.V.M. Medical College, kanpur, 208002
Kanpur Nagar
UTTAR PRADESH |
07499339329
drrkverma.research@gmail.com |
| DrT Sudheer |
Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
Orthopaedics Department,
Srikakulam-532 001,
Andhra Pradesh.
Srikakulam
ANDHRA PRADESH |
9949900369
drtsudheer@gmail.com |
| Dr Atul Kakar |
Sir Ganga Ram Hospital |
Department of Rheumatology
SGRH Marg, Rajinder Nagar,
New Delhi-110060
New Delhi
DELHI |
9811110802
akakar@hotmail.com |
| Dr Piyush N Joshi |
Sterling Hospital |
2nd Floor, Sterling Hospital Road, Memnagar,
Ahmedabad -380052.
Gujarat.
Ahmadabad
GUJARAT |
8879102056
pnjoshi2005@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| AMCMET Ethics Committee |
Submittted/Under Review |
| Care Hospital Nagpur Ethics Committee, |
Submittted/Under Review |
| Ethics Committee GSVM Medical College |
Approved |
| Ethics Committee, Indira Gandhi Institute of Medical Sciences |
Approved |
| Ethics Committee, Rajiv Gandhi Institute of Medical Sciences & RIMS Government Hospital |
Approved |
| Institutional Ethics Committee (IEC), KLE University, JN Medical College |
Approved |
| Institutional Ethics Committee for Human Research, Medical College, Kolkata |
Submittted/Under Review |
| Institutional Ethics Committee, King George Hospital |
Approved |
| Institutional Ethics Committee, GCS Medical College, Hospital & Research Centre |
Approved |
| Institutional Ethics Committee, Grant Govt. Medical College, Sir JJ Group of Hospitals, Mumbai |
Approved |
| Institutional Ethics Committee, Maharaja Agarsen Hospital |
Approved |
| Institutional Ethics Committee, Padmashree Dr D Y Patil Medical College |
Approved |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research |
Submittted/Under Review |
| Institutional Ethics Committee, Sterling Hospital |
Submittted/Under Review |
| LPR Ethics Committee |
Submittted/Under Review |
| Sir Ganga Ram Hospital Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Active Rheumatoid Arthritis, (1) ICD-10 Condition: E888||Other specified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Iguratimod Tablets 25 mg |
Once daily for first 4 weeks and escalate to twice daily for remaining 28 weeks |
| Comparator Agent |
Methotrexate Tablets 25 mg |
Once in a week for 28 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who had been diagnosed with active RA, according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for Rheumatoid Arthritis (ACR) criteria, and Disease Activity Score 28 (DAS28) greater than or equal to 3.2.
2. Tender joint count/swollen joint count ≥6.
3. Patients who have failed at least one cycle of DMRD therapy, defined as subject who has failed to achieve remission after Methotrexate 15mg/week regime for 3 months. |
|
| ExclusionCriteria |
| Details |
1. Subjects who have participated in other clinical studies within 3 months.
2. Any condition which are likely to hinder the compliance with the protocol.
3. Subjects suffering under treatment of any chronic infection.
4. Subject with history of intra-articular infection within last four weeks.
5. Subjects with dosage of steroids more than 7.5mg/day.
6. Patients not on a stable dose of steroids for last 1 month.
7. Patients with significant systemic manifestations of rheumatoid arthritis.
8. Rheumatic auto-immune disease other than rheumatoid arthritis/overlap syndromes.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of subjects meeting the American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response criteria. |
At the end of week 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Change from baseline in Health Assessment Questionnaire (HAQ). |
At the end of week 28 |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
Final Enrollment numbers achieved (Total)= "244"
Final Enrollment numbers achieved (India)="244" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2017 |
| Date of Study Completion (India) |
07/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is A Comparative, Two Arm, Randomized, Double
Blind, Parallel Group, Multicentric, Non-Inferior Clinical Study to Evaluate
Efficacy, Safety and Tolerability of Iguratimod Tablets 25 mg as an add on Therapy
over Methotrexate Tablets 15 mg Vs.
Methotrexate Tablets 25 mg for the treatment of Patients with Active Rheumatoid
Arthritis. Primary objective of this trial is to study the Percentage of
subjects meeting the American College of Rheumatology 20% (ACR20), 50% (ACR50)
and 70% (ACR70) response criteria. |