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

NCT ID: NCT03855007

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2023-10-31

Brief 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.

Detailed 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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iguratimod

The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX), hydroxychloroquine (HCQ) , prednisone (Pred) step by step

Group Type: EXPERIMENTAL

Iguratimod

Intervention Type: DRUG

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.

MTX

Intervention Type: DRUG

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

HCQ

Intervention Type: DRUG

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

Pred

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

HCQ

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

Intervention Type: DRUG

Pred

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

Intervention Type: DRUG

Other Intervention Names

T-614; methotrexate; Hydroxychloroquine; Prednisone

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Qiang Shu

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Lv, Dr.

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

Iguratimod-ERA QiluH

Identifier Type: -

Identifier Source: org_study_id