Clinical Trials Logo
  1. Home
  2. Arthritis, Rheumatoid
  3. NCT03855007

The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment

Arthritis, Rheumatoid Clinical Trial

Official title:
Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China

Clinical Trial Summary

This study is designed to observed prospectively the efficacy and safety of 6 months treatment of iguratimod alone, or with methotrexate (MTX), hydroxychloroquine (HCQ) and prednisone step by step on Chinese rheumatoid arthritis (RA) and early rheumatoid arthritis (ERA) patients who were naïve or shown insufficiency response or intolerance to DMARDs. If volunteered, patients who completed the 6-month study can continue to follow our plans for 24 months.

Clinical Trial Description

This study will enroll 200 cases of rheumatoid arthritis (RA) and early rheumatoid arthritis (ERA) patients in China, who are naïve or shown insufficiency response or intolerance to DMARDs. The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX)/ hydroxychloroquine (HCQ) / prednisone (Pred) step by step for 6 months if participants are in medium or high disease activity (DAS28≥3.2). Participants can choose to continue the study up to 24 months.The efficacy and safety of 6 months and 24 months Iguratimod treatment in RA and ERA patients will be evaluated with DAS28-ESR and other disease activity indices. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03855007
Study type Interventional
Source Qilu Hospital of Shandong University
Contact
Status Completed
Phase Phase 4
Start date January 1, 2016
Completion date October 31, 2023
View Details
See also
  Status Clinical Trial Phase
Terminated NCT01682512 - Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis Phase 3
Completed NCT00539760 - A Phase I Rheumatoid Arthritis Study in Healthy Volunteers Phase 1
Active, not recruiting NCT03312465 - Anatomical Shoulder Domelock System Study
Completed NCT01208181 - A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107) Phase 3
Completed NCT03254810 - Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects Phase 1
Completed NCT01711814 - A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study Phase 2
Completed NCT03315494 - Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers Phase 1
Withdrawn NCT03241446 - Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA) Phase 1
Completed NCT02748785 - MTX Discontinuation and Vaccine Response Phase 4
Completed NCT02553018 - Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe Phase 3
Active, not recruiting NCT02260778 - Treat-to-target in RA: Collaboration To Improve adOption and adhereNce N/A
Completed NCT02569736 - Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation
Completed NCT01750931 - This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets. Phase 2
Not yet recruiting NCT01154647 - Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes N/A
Withdrawn NCT01204138 - Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA Phase 2
Completed NCT00913458 - Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis Phase 4
Completed NCT00973479 - An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy Phase 3
Completed NCT00975130 - Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) Phase 3
Completed NCT00660647 - Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA) Phase 3
Completed NCT00550446 - A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis Phase 2