NCT05626348RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 29 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 15 Nov 2022
- Start date
- 22 Dec 2021
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Qilu Hospital of Shandong University
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05626348
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- From 22 Dec 2021 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with combined active hepatitis
- Patients with active tuberculosis
- Patients withinfection and malignancy
Who the study is looking for
- \-
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qilu Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.