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

Phase 4

• Conditions: Health Condition 1: M248- Other specific joint derangements,not elsewhere classified

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 DMARDââ?¬•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