RECRUITINGPhase 4INTERVENTIONAL

The Clinical Efficacy of Immunomodulators in RA Patients

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: \- 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 willing to sign a consent form form ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

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.

DRUG

Methotrexate

Methotrexate，10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

DRUG

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.

DRUG

Leflunomide

Leflunomide，20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

DRUG

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.

Locations (1)

Qilu Hospital

Jinan, Shandong, China