Open label, prospective, non-comparative, multicentric, phase IV clinical study of Iguratimod tablets 25 mg

Phase 4

Recruiting

• Conditions: Other specific joint derangements,not elsewhere classified,

• Registration Number: CTRI/2022/03/041073
• Lead Sponsor: Ajanta Pharma Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Adverse events, SAE or abnormal lab values
•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.	Adverse events, SAE or abnormal lab values
•Changes in laboratory safety parameters from baseline to end of the study.	Adverse events, SAE or abnormal lab values

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (12)

Banaras Hindu University (BHU),; 🇮🇳 Varanasi, UTTAR PRADESH, India

Care and Cure Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

College of Medicine & Sagore Dutta Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Govt Medical College and Govt General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

GSVM; 🇮🇳 Nagar, UTTAR PRADESH, India

JLN Kalabaug Ajmer; 🇮🇳 Ajmer, RAJASTHAN, India

Nil Ratan Sircar Medical College and Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Rajalakshmi Hospital & Research Center; 🇮🇳 Bangalore, KARNATAKA, India

Shivam Orthopedic and Medical Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Swara Hospital; 🇮🇳 (Suburban), MAHARASHTRA, India

Scroll for more (2 remaining)

Banaras Hindu University (BHU),

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Nilesh Kumar

Principal investigator

9889655100

nilesh19arreno@gmail.com