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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT03855007
• Date of registration: 15/02/2019
• Prospective Registration: No
• Primary sponsor: Qilu Hospital of Shandong University
• Public title: The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment
• Scientific 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
• Date of first enrolment: January 1, 2016
• Target sample size: 400
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03855007
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

China

Contacts

• Name: Ming Lv, Dr.
• Affiliation: Qilu Hospital of Shandong University

Key inclusion & exclusion criteria

Inclusion Criteria: -

1. RA: Patients diagnosed based on 1987 ACR classification criteria for rheumatoid
arthritis(RA);

2. ERA: Subjects diagnosed by the 2010 American College of Rheumatology/European League
Against Rheumatism (ACR/EULAR); or by 2012 Chinese classification criteria of early
rheumatoid arthritis (ERA), and not match the 1987 ACR criteria for RA.

3. Age =16 years;

4. Extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia
and peripheral neuropathy ) of RA patients are stable or no significant progress;

5. Patients can be naïve to any DMARDs, or relapse due to DMARDs drug suspended;

6. Patients have a history of using csDMARDs including csDMARDs(methotrexate,leflunomide,
hydroxychloroquine, sulfasalazine, tacrolimus) , any biologic DMARDs(TNFi,tocilizumab
or Tofacitinib),glucocorticoid (prednisone,methylprednisolone) or Chinese traditional
Medicine(including tripterygium Glycosides, sinomenine)for 3 months, but couldn't
achieve clinical remission or intolerance;

Exclusion Criteria:

1. Patients with acute or chronic infections such as active bacterial, viral, fungal,
tuberculosis infection or active hepatitis B;

2. Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x 10^9 / L;

3. Propionate acid aminotransferase (ALT) or aspartate aminotransferase (AST) is two
times higher than the upper limit of normal;

4. Renal insufficiency: serum Cr = 176 umol / L;

5. Pregnant or nursing women (breastfeeding) ;

6. Patients has a history of malignancy (cure time in less than 5 years);

7. Patients with severe or poorly controlled hypertension, diabetes or cardiac
dysfunction;

8. Other comorbidities that cannot be treated with immune suppressants. In addition, once
patients experience severe adverse drug reactions?ineffective treatment or rapid
progression of rheumatoid arthritis, then quit this research.



Age minimum: 16 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Pred

Drug: HCQ

Drug: Iguratimod

Drug: MTX

Primary Outcome(s)

The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28 [Time Frame: week 24]

Secondary Outcome(s)

Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: Up to week 96]

Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every 3 months [Time Frame: Up to week 96]

Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 12 [Time Frame: week 12]

The percentage of patients who achieve clinical remission using DAS28-ESR at week 12 [Time Frame: week 12]

Change From Baseline in C-reactive Protein (CRP) [Time Frame: Up to week 96]

The percentage of patients who achieve clinical remission using DAS28-ESR at week 48 [Time Frame: week 48]

Change from baseline Clinical Disease Activity Index (CDAI) [Time Frame: Up to week 96]

Incidence of participant withdrawal [Time Frame: Up to week 96]

Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 96 [Time Frame: week 96]

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) [Time Frame: Up to week 96]

Change from baseline Simplified Disease Activity Index (SDAI) [Time Frame: Up to week 96]

The percentage of patients who achieve clinical remission using DAS28-ESR at week 96 [Time Frame: week 96]

Percentage of participants achieving ACR/EULAR remission at week 12 [Time Frame: week 12]

Number of participants with"adverse events (AEs)" [Time Frame: Up to week 96]

Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 24 [Time Frame: week 24]

Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 48 [Time Frame: week 48]

Percentage of participants achieving ACR/EULAR remission at week 24 [Time Frame: week 24]

Percentage of participants achieving ACR/EULAR remission at week 48 [Time Frame: week 48]

Percentage of participants achieving ACR/EULAR remission at week 96 [Time Frame: week 96]

Secondary ID(s)

Iguratimod-ERA QiluH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors