Evaluating Immunomodulators for Rheumatoid Arthritis Treatment

The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China

This study is testing different combinations of medications for people with rheumatoid arthritis to see which ones help reduce symptoms and improve their condition.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT05626348 on ClinicalTrials.gov

What this trial studies

This study investigates the clinical efficacy of various immunomodulators in patients with rheumatoid arthritis (RA), including those who are naive to treatment and those who have inadequate responses to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Participants will receive different treatment regimens, such as combinations of Iguratimod with csDMARDs or csDMARDs with TNF inhibitors, over a 24-week period. The study aims to assess disease activity, drug response, and evaluate biomarkers in plasma and synovial fluid to predict treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with rheumatoid arthritis who meet specific classification criteria and experience knee dysfunction.

Not a fit: Patients with rheumatoid arthritis who do not meet the inclusion criteria or have contraindications to the treatments being tested may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with rheumatoid arthritis, improving their quality of life.

How similar studies have performed: Previous studies have shown promising results with similar immunomodulatory approaches in rheumatoid arthritis treatment, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

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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

Where this trial is running

Jinan, Shandong

• Qilu Hospital — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Qiang Shu, Dr.

Conditions Arthritis, Rheumatoid; csDMARDs; TNFi