| CTRI Number |
CTRI/2025/02/080435 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Iguratimod 25mg BD or Leflunomide 20mg OD either of any one drug is given to RA patients, who has shown no response or inadequate response to Methotrexate and HCQS. Hence study is done to evaluate the effectiveness of Iguratimod or Leflunomide in Rheumatoid Arthritis patients |
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Scientific Title of Study
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Open label, randomized, investigator initiated clinical study to evaluate efficacy and safety of Iguratimod tablets 25mg twice daily and Leflunomide tablets 20mg as DMARD in patients with inadequate response to methotrexate and hydroxychloroquine in patients with active rheumatoid arthritis.
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandrashekara S |
| Designation |
Principle Investigator |
| Affiliation |
Chanre Rheumatology and Immunology Center and Research |
| Address |
ChanRe Rheumatology and Immunology Center and Research
No 414/65 20th Main West of Chord Road
1st Block Rajajinagara Bangalore
Department of Rheumatology, 3rd floor, MD room, No 414/65 20th Main West of Chord Road 1st Block Rajajinagara Bangalore 560010
Bangalore
KARNATAKA
560010
India |
| Phone |
9845071151 |
| Fax |
08042516600 |
| Email |
drchandrashekara@chanrericr.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekara S |
| Designation |
Principle Investigator |
| Affiliation |
Chanre Rheumatology and Immunology Center and Research |
| Address |
ChanRe Rheumatology and Immunology Center and Research
No 414/65 20th Main West of Chord Road
1st Block Rajajinagara Bangalore
Department of Rheumatology, 3rd floor, MD room, No 414/65 20th Main West of Chord Road 1st Block Rajajinagara Bangalore 560010
Bangalore
KARNATAKA
560010
India |
| Phone |
9845071151 |
| Fax |
08042516600 |
| Email |
drchandrashekara@chanrericr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devaraj Kori |
| Designation |
Medical administrator |
| Affiliation |
Chanre Rheumatology and Immunology Center and Research |
| Address |
No 414/65 20th Main West of Chord Road 1st Block Rajajinagar Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
9731111386 |
| Fax |
|
| Email |
drdevaraj.kori@gmail.com |
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Source of Monetary or Material Support
|
| ChanRe Rheumatology and Immunology center and research
No 414/65 20th Main West of Chord Road 1st Block Rajajinagara Bangalore 560010 unconditional grants from IPCA laboratories limited
Kandivli Industrial Estate Kandivli west Mumbai Maharashtra 400067 |
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Primary Sponsor
|
| Name |
ChanRe Rheumatology and Immunology Center and Research |
| Address |
No 414/65 20th Main West of Chord Road 1st Block Rajajinagara Bangalore 560010 |
| Type of Sponsor |
Private hospital/clinic |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandrashekara S |
Chanre Rheumatology and Immunology Center and Research |
No 414/65 20th Main West of Chord Road 1st Block Rajajinagara Bangalore 560010
Bangalore
KARNATAKA |
9845071151
08042516600
drchandrashekara@chanrericr.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Iguratimod 25mg |
twice daily oral route for 26 weeks |
| Comparator Agent |
Leflunomide 20mg |
once daily oral route for 26 weeks |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects of age of 18 to 65 years, both inclusive.
2. 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.
3. Tender joint count/swollen joint count ≥6.
4. Subjects meeting at least one of the following three conditions: erythrocyte sedimentation rate of at least 28 mm/hour, C-reactive protein (CRP) of at least 15 mg/liter
5. Patients who have failed the combination therapy, defined as subject who has failed to achieve remission after MTX+HCQ regime for 3 months.
6. Subject willing to sign informed consent form (ICF).
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| ExclusionCriteria |
| Details |
1. Subjects treated with any biological injection within last 3 months.
2. Subjects with inadequate bone marrow function (defined as an absolute neutrophil count
of not more than 2.5x10 to the power 9 per liter).
3.AST is greater than 1.5xULN (AST is equal to 10 to 34 IU per liter), AST greater than 1.5xULN (ALT is equal to 10 to 40 IU per liter). Cr is equal to 1.534
4. WBC is less than 4x10 to the power 9 per liter, HGB less than 85 grams per liter, PLT less than 100x10 to the power 9 per liter.
5. Subjects on current therapy of Iguratimod, Leflunomide, and Sulfasalazine, either separately or in combinations thereof.
6. Subjects receiving live vaccines within 3 months prior to study entry.
7. A history of hypersensitivity to any of the study drugs.
8. Pregnant women, nursing mothers and during treatment requirements of women of childbearing age.
9. Subjects with active gastrointestinal ulceration / bleeding, or history of peptic ulcers.
10. Subjects with known or suspected positive serology for human immunodeficiency,
hepatitis B or C virus.
11. Subjects with history of any malignancies.
12. Subjects suffering from severe serious hepatic, cardiovascular, renal, hematologic
or endocrine diseases.
13. Subjects who have participated in other clinical studies within 3 months.
14. Any condition which are likely to hinder the compliance with the protocol.
15. Subjects suffering under treatment of any chronic infection.
16. Subject with history of intra-articular infection within last four weeks.
17. Subjects with dosage of steroids more than 7.5mg/day.
18. Patients not on a stable dose of steroids for last 1 month.
19. Patients with significant systemic manifestations of rheumatoid arthritis.
20. Rheumatic auto-immune disease other than rheumatoid arthritis/overlap syndromes.
21. Any surgery of bone fractures within 8 weeks.
22. Malignancies i.e., solid or hematological.
23. Alcohol or drug abuse within 6 months
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
Number of subject achieved the DAS 28 ESR score less than 2.6
Mean Reduction in Disease Activity Score 28 (DAS28) from baseline
|
3 time points |
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Secondary Outcome
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| Outcome |
TimePoints |
| Safety of the drug |
6 months |
|
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Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
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Date of First Enrollment (India)
|
24/02/2025 |
| 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 |
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Estimated Duration of Trial
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Years="0"
Months="8"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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The study will be carried out to evaluate efficacy and safety of Iguratimod and/or Leflunomide as an addon therapy to methotrexate and HCQs in patients with active RA who have not responded to Methotrexate and Hydroxyquinone combination treatment. In the current practice by rheumatologist either leflunomide or Iguratimod is used in this situation. There are no studies which compare the efficacy of these two drugs in this situation. Usual choice is based on random choice of the clinician. The study aim to create some data to understand the choice between these two drugs in this situation. In addition the study also help to understand the safety of this drug in this circumstances Mean change in clinical Activity DAS 28 from baseline to end of therapy [26th week plus or minus 3days] is the primary objective. Secondary objective is the achievement of remission. And the safety of the drugs
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