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.
Methotrexate: 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: 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.
Leflunomide: Leflunomide，20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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
Primary outcome measure(s)
The percentage of patients who achieve clinical remission using European League Against Rheumatism (EULAR) response criteria DAS28. — week 24 The percentage of patients whose Disease Activity Score in 28 Joints (DAS28) achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2). The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure erythrocyte sedimentation rate (ESR, mm/h) or C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity i.e. 'global assessment of health' (GH) using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst. DAS28 values were calculated as follows: DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x GH. High disease activity: DAS28-ESR \> 5.1; Moderate disease activity: 5.1≥ DAS28 \> 3.2 to 5.1; Low disease activity (LDA) and Remission mean Clinical remission.
Trial sites (1)
Facility
City
Region
Status
Qilu Hospital
Jinan
Shandong
Recruiting
More Qilu Hospital of Shandong University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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