The Clinical Efficacy of Immunomodulators in RA Patients

NCT05626348 | Recruiting Phase 4

• 1 other identifier: Response of DMARDs in RA QiluH
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study includes naive patients and csDMARDs-IR RA patients, treated with different regimens such as Iguratimod combination of different csDMARDs, or csDMARD with TNF inhibitors for 24 weeks. The disease activity and drug response will be observed. The immune disorder and synovial function will be evaluated at the same time.

Conditions

Arthritis, Rheumatoid

Keywords

csDMARDs; TNFi

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who achieve clinical remission 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 (11)

• The percentage of patients who achieve clinical remission using DAS28-ESR.

  week 12

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

  baseline,week 12,week 24

• Percentage of participants achieving ACR/EULAR remission

  week 12,week 24

• Change from baseline Simplified Disease Activity Index (SDAI)

  up to week 24

• Change from baseline Clinical Disease Activity Index (CDAI)

  up to week 24

Study Arms (3)

Methotrexate(MTX)+Iguratimod(IGU)

EXPERIMENTAL

Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Methotrexate(MTX)，10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. For RA patients with naive or csDMARDs-IR

Drug: Iguratimod; Drug: Methotrexate

Adalimumab+Methotrexate(MTX)

EXPERIMENTAL

Drug: Adalimumab，40mg, iH,q2w, once two weeks (q2w) prescribed at the beginning and adjusted due to patient response. Drug: Methotrexate(MTX)，7-10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. For RA patients with csDMARDs-IR

Drug: Methotrexate; Drug: Adalimumab Injection

Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)

EXPERIMENTAL

Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Leflunomide(LEF)，20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Drug: Hydroxychloroquine(HCQ)，200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. For RA patients with csDMARDs-IR

Drug: Iguratimod; Drug: Leflunomide; Drug: Hydroxychloroquine

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: IGU, T-614

Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ); Methotrexate(MTX)+Iguratimod(IGU)

Methotrexate DRUG

Methotrexate，10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Also known as: MTX

Adalimumab+Methotrexate(MTX); Methotrexate(MTX)+Iguratimod(IGU)

Adalimumab Injection DRUG

Adalimumab Injection，40mg，iH，every two weeks (q2w) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Also known as: adalimu

Adalimumab+Methotrexate(MTX)

Leflunomide DRUG

Leflunomide，20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Also known as: LEF

Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)

Hydroxychloroquine DRUG

Hydroxychloroquine，200mg, 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: HCQ

Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with RA who meet ACR 1987 rheumatoid arthritis classification criteria or ACR/EULAR 2010 rheumatoid arthritis Classification Criteria and have knee dysfunction.
• ACR 1987 rheumatoid arthritis classification criteria
• morning stiffness lasting at least 1 hour (≥6w)
• there are 3 or more joint areas swollen (≥6w)
• swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (≥6w)
• symmetrical arthrogryposis (≥6w)
• hand x-ray changes (at least osteoporosis and joint space narrowing)
• positive rheumatoid factor (titer \> 1:32) RA can be diagnosed by meeting 4 of the above 7 items
• ACR/EULAR 2010 rheumatoid arthritis Classification Criteria
• Involved joints
• \- 1 large joint (0 points)
• large joints (1 point)
• small joints (with or without large joints) (2 points)
• small joints (with or without large joints) (3 points)
• more than 10 small joints (at least one small joint) (5 points)

You may not qualify if:

• Patients with combined active hepatitis
• Patients with active tuberculosis
• Patients withinfection and malignancy

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

iguratimod; glucose utilization inhibitor; T 614; Methotrexate; Adalimumab; Leflunomide; Hydroxychloroquine

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; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Chloroquine; Aminoquinolines; Quinolines

Study Officials

• Xiaoyun Yang

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Qiang Shu, Dr.

CONTACT

0086-0531-82169654; shuqiang@sdu.edu.cn

Bingbing Ren

CONTACT

0086-18765361979; sdrenbingbing@163.com

Study Design

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

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: December 22, 2021
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CN (1)