A Clinical Study to Evaluate Efficacy, Safety and Tolerability of Iguratimod Tablets Vs. Methotrexate Tablets for the treatment of Active Rheumatoid Arthritis.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/07/009079

Enrollment

260

Registered

2017-07-19

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Active Rheumatoid Arthritis Health Condition 2: E888- Other specified metabolic disorders

Interventions

Intervention1: Iguratimod Tablets 25 mg: Once daily for first 4 weeks and escalate to twice daily for remaining 28 weeks Control Intervention1: Methotrexate Tablets 25 mg: Once in a week for 28 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Percentage of subjects meeting the American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response criteria.Timepoint: At the end of week 28	—

Secondary

Measure	Time frame
Mean Change from baseline in Health Assessment Questionnaire (HAQ).Timepoint: At the end of week 28	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd

shailesh.singh@ajantapharma.com2266062111

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026