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

Phase 3

Completed

• Conditions: Other specified metabolic disorders,

• Registration Number: CTRI/2017/07/009079
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is A Comparative, Two Arm, Randomized, DoubleBlind, Parallel Group, Multicentric, Non-Inferior Clinical Study to EvaluateEfficacy, Safety and Tolerability of Iguratimod Tablets 25 mg as an add on Therapyover Methotrexate Tablets 15 mg  Vs.Methotrexate Tablets 25 mg for the treatment of Patients with Active RheumatoidArthritis. Primary objective of this trial is to study the Percentage ofsubjects meeting the American College of Rheumatology 20% (ACR20), 50% (ACR50)and 70%  (ACR70) response criteria.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-25
• Study Completion: 2018-07-09
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 260

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

• 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.
• 8.Rheumatic auto-immune disease other than rheumatoid arthritis/overlap syndromes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Mean Change from baseline in Health Assessment Questionnaire (HAQ).	At the end of week 28

Trial Locations

Locations (16)

AMCMET Medical College & L. G. General Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. D. Y. Patil Hospital and Research Centre; 🇮🇳 Thane, MAHARASHTRA, India

Ganga Care Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

GCS Medical College Hospital & Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Grant Govt. Medical College & Sir J J Group of Hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

Indira Gandhi Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

KLE’s Dr. Prabhakar Kore Hospital and MRC; 🇮🇳 Belgaum, KARNATAKA, India

Lifepoint Multispecialty hospital; 🇮🇳 Pune, MAHARASHTRA, India

Maharaja Agrasen Hospital; 🇮🇳 Delhi, DELHI, India

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AMCMET Medical College & L. G. General Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Jesalpura Bhavesh Harshdray

Principal investigator

9033023000

Bjesalpura@yahoo.com