Evaluating Immunomodulators for Rheumatoid Arthritis Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Qilu Hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Qiang Shu, Dr.
• Email: shuqiang@sdu.edu.cn
• Phone: 0086-0531-82169654

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.