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โ† Trials
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The Clinical Efficacy of Immunomodulators in RA Patients

RecruitingPhase 4Ages 18 Years - 80 YearsAllQilu Hospital of Shandong University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ6w) 2. there are 3 or more joint areas swollen (โ‰ฅ6w) 3. swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (โ‰ฅ6w) 4. symmetrical arthrogryposis (โ‰ฅ6w) 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) * โ‰ฅ6 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 โ‰ค 30 minutes d, age โ‰ฅ 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
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What it tests

  • Iguratimod
  • Methotrexate
  • Adalimumab Injection
  • Leflunomide
  • Hydroxychloroquine
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Where

1 site
Qilu Hospital
Jinan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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