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

NCT03855007 | Completed Phase 4

• 1 other identifier: Iguratimod-ERA QiluH
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid

Keywords

Iguratimod

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28

  The percentage of patients whose Disease Activity Score in 28 Joints (DAS28) achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2). The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure erythrocyte sedimentation rate (ESR, mm/h) or C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity i.e. 'global assessment of health' (GH) using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst. DAS28 values were calculated as follows: DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x GH. High disease activity: DAS28-ESR \> 5.1; Moderate disease activity: 5.1≥ DAS28 \> 3.2 to 5.1; Low disease activity (LDA) and Remission mean Clinical remission.

  week 24

Secondary Outcomes (19)

• The percentage of patients who achieve clinical remission using DAS28-ESR at week 12

  week 12

• The percentage of patients who achieve clinical remission using DAS28-ESR at week 48

  week 48

• The percentage of patients who achieve clinical remission using DAS28-ESR at week 96

  week 96

• Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 12

  week 12

• Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 24

  week 24

Study Arms (1)

Iguratimod

EXPERIMENTAL

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

Drug: Iguratimod; Drug: MTX; Drug: HCQ; Drug: Pred

Interventions

Iguratimod 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.

Also known as: T-614

Iguratimod

MTX DRUG

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

Also known as: methotrexate

Iguratimod

HCQ DRUG

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

Also known as: Hydroxychloroquine

Iguratimod

Pred DRUG

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

Also known as: Prednisone

Iguratimod

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• RA: Patients diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis(RA);
• 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.
• Age ≥16 years;
• Extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia and peripheral neuropathy ) of RA patients are stable or no significant progress;
• Patients can be naïve to any DMARDs, or relapse due to DMARDs drug suspended;
• 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；

You may not qualify if:

• Patients with acute or chronic infections such as active bacterial, viral, fungal, tuberculosis infection or active hepatitis B;
• Platelet counts(PLT) \<80 x 10\^9 / L, or white blood cell (WBC) \<3 x 10\^9 / L;
• Propionate acid aminotransferase (ALT) or aspartate aminotransferase (AST) is two times higher than the upper limit of normal;
• Renal insufficiency: serum Cr ≥ 176 umol / L;
• Pregnant or nursing women (breastfeeding) ；
• Patients has a history of malignancy (cure time in less than 5 years);
• Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

iguratimod; T 614; Methotrexate; Hydroxychloroquine; prednylidene; Prednisone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chloroquine; Aminoquinolines; Quinolines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ming Lv, Dr.

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Drug: Iguratimod（T-614），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint. Drug: Methotrexate （MTX），7.5mg to 15mg, po, once per week (Qw) prescribed if needed and adjusted due to patient response or unacceptable toxicity develops. Drug: Hydroxychloroquine （HCQ），200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. Drug: Prednisone （Pred）： 5-15mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 26, 2019
• Study Start: January 1, 2016
• Primary Completion: September 30, 2023
• Study Completion: October 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)