Compares medicines for rheumatoid arthritis in adults over 6 months
Tests several medicine combinations, including iguratimod, in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: The Clinical Efficacy of Immunomodulators in RA Patients
Key facts
- Where
- Jinan, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with rheumatoid arthritis or knee osteoarthritis who have knee problems, and for age- and sex-paired healthy volunteers. Rheumatoid arthritis patients are treated for 24 weeks.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Rheumatoid arthritis meeting the ACR 1987 or ACR/EULAR 2010 criteria, or knee osteoarthritis meeting the 1995 criteria, with knee dysfunction.
- Earlier treatment
- The study includes patients who have not been treated before and patients whose earlier csDMARD treatment did not work well enough.
Main reasons for not taking part
- Active hepatitis
- Active tuberculosis
- Infection
- Cancer (malignancy)
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05626348, who can take part
Where in China
- Qilu HospitalJinan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Qilu Hospital of Shandong University
- Trial code
- NCT05626348
- Record updated
- 29 November 2022
- Original description
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.Read full original descriptionShow less
The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China
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.
Inclusion: -; 1.Patients with RA who meet ACR 1987 rheumatoid arthritis classification criteria or ACR/EULAR 2010 rheumatoid arthritis Classification Criteria and have knee dysfunction; ACR 1987 rheumatoid arthritis classification criteria; morning stiffness lasting at least 1 hour (≥6w); there are 3 or more joint areas swollen (≥6w); swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (≥6w); symmetrical arthrogryposis (≥6w); hand x-ray changes (at least osteoporosis and joint space narrowing); positive rheumatoid factor (titer > 1:32) RA can be diagnosed by meeting 4 of the above 7 items; ACR/EULAR 2010 rheumatoid arthritis Classification Criteria; 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); 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); Acute chronotropic reactants; Both CRP and ESR normal (0 points); Abnormal CRP or ESR (1 point); 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; 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: Patients with combined active hepatitis; Patients with active tuberculosis; Patients withinfection and malignancy.