NCT05626348 The Clinical Efficacy of Immunomodulators in RA Patients
| NCT ID | NCT05626348 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Arthritis, Rheumatoid |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2021-12-22 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2021-12-22 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Xiaoyun Yang
STUDY DIRECTOR
Qilu Hospital of Shandong University
Frequently Asked Questions
Who can join the NCT05626348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Arthritis, Rheumatoid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05626348 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05626348 currently recruiting?
Yes, NCT05626348 is actively recruiting participants. Contact the research team at shuqiang@sdu.edu.cn for enrollment information.
Where is the NCT05626348 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT05626348 clinical trial?
NCT05626348 is sponsored by Qilu Hospital of Shandong University. The principal investigator is Xiaoyun Yang at Qilu Hospital of Shandong University. The trial plans to enroll 400 participants.