The Clinical Efficacy of Immunomodulators in RA Patients

Shandong University

Status and phase: Enrolling; Phase 4

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Methotrexate; Drug: Leflunomide; Drug: Adalimumab Injection; Drug: Iguratimod; Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT05626348

Response of DMARDs in RA QiluH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups

Methotrexate(MTX)+Iguratimod(IGU)

Experimental group

Description:

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

Treatment:

Drug: Iguratimod

Drug: Methotrexate

Adalimumab+Methotrexate(MTX)

Experimental group

Description:

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

Treatment:

Drug: Adalimumab Injection

Drug: Methotrexate

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

Experimental group

Description:

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

Treatment:

Drug: Hydroxychloroquine

Drug: Iguratimod

Drug: Leflunomide