NCT03855007View on ClinicalTrials.gov

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

PHASE4CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

January 1, 2016

Primary Completion Date

September 30, 2023

Study Completion Date

October 31, 2023

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

Iguratimod

Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

DRUG

MTX

MTX，7.5mg to 15mg, po, once per week (Qw) prescribed if needed and adjusted due to patient response or unacceptable toxicity develops.

DRUG

HCQ

HCQ，200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.

DRUG

Pred

Pred, 5-15mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response

Trial Locations (1)

250012

Qilu Hospital, Jinan

All Listed Sponsors
lead

Qilu Hospital of Shandong University

OTHER

NCT03855007 - The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment | Biotech Hunter | Biotech Hunter