The Clinical Efficacy of Immunomodulators in RA Patients

NCT ID: NCT05626348

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-22
• Study Completion Date: 2026-12-31

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.

Detailed Description

In this study cohorts, naïve or csDMARDs-IR patients are treated with different csDMARDs combination or TNF inhibitors for 24 weeks to get remission in clinical. The biomarkers in their plasma and synovial fluid and tissue specimens from RA patients are screened to predict the efficacy of specific treatment.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methotrexate(MTX)+Iguratimod(IGU)

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

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.

Methotrexate

Intervention Type: DRUG

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

Adalimumab+Methotrexate(MTX)

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

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

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

Adalimumab Injection

Intervention Type: 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.

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

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

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.

Leflunomide

Intervention Type: DRUG

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

Hydroxychloroquine

Intervention Type: 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.

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

Methotrexate

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

Intervention Type: DRUG

Adalimumab Injection

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.

Intervention Type: DRUG

Leflunomide

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

Intervention Type: DRUG

Hydroxychloroquine

Hydroxychloroquine，200mg, 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

Other Intervention Names

IGU; T-614; MTX; adalimu; LEF; HCQ

Eligibility Criteria

Inclusion Criteria

-

1.Patients with RA who meet ACR 1987 rheumatoid arthritis classification criteria or ACR/EULAR 2010 rheumatoid arthritis Classification Criteria and have knee dysfunction.

1. ACR 1987 rheumatoid arthritis classification criteria

1. morning stiffness lasting at least 1 hour (≥6w)

2. there are 3 or more joint areas swollen (≥6w)

3. swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (≥6w)

4. symmetrical arthrogryposis (≥6w)

5. hand x-ray changes (at least osteoporosis and joint space narrowing)

6. positive rheumatoid factor (titer > 1:32) RA can be diagnosed by meeting 4 of the above 7 items

2. ACR/EULAR 2010 rheumatoid arthritis Classification Criteria

1. Involved joints

• 1 large joint (0 points)
• 2-10 large joints (1 point)
• 1-3 small joints (with or without large joints) (2 points)
• 4-10 small joints (with or without large joints) (3 points)
• more than 10 small joints (at least one small joint) (5 points)

2. Serological indicators

• RF and ACPA negative (0 points)
• RF and ACPA, at least one of which is low titer positive. (2 points)
• RF and ACPA with at least one high titer positive (3 points)

3. Acute chronotropic reactants

• Both CRP and ESR normal (0 points)
• Abnormal CRP or ESR (1 point)

4. Duration of synovitis

• <6 weeks (0 points)
• ≥6 weeks (1 point)

2.Patients with OA who meet the 1995 Classification Criteria for OA and have knee dysfunction 1995 Classification Criteria for Osteoarthritis of the Knee Clinical criteria

a. Knee pain most of the time in the last 1 month b. Bone rubbing sound c, morning stiffness ≤ 30 minutes d, age ≥ 38 years e, with bony enlargement Knee OA can be diagnosed if a+b+c+d or a+b+e is met

3.Age-sex matched healthy volunteers who checked in our hospital.

4.Age > 18 years old;

5.Voluntarily participate in this study and sign an informed consent form

Exclusion Criteria

1. Patients with combined active hepatitis

2. Patients with active tuberculosis

3. Patients withinfection and malignancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 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

Xiaoyun Yang

Role: STUDY_DIRECTOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiang Shu, Dr.

Role: CONTACT

shuqiang@sdu.edu.cn

0086-0531-82169654

Bingbing Ren

Role: CONTACT

sdrenbingbing@163.com

0086-18765361979

Facility Contacts

Xiaoyun Yang, Dr.

Role: primary

qlyykyc@163.com

0086-0531-82169166

Other Identifiers

Response of DMARDs in RA QiluH

Identifier Type: -

Identifier Source: org_study_id