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Tests treatment safety and results for Arthritis, Rheumatoid
Official title The Clinical Efficacy of Immunomodulators in RA Patients
ClinicalTrials.gov ID: NCT05626348
What this study is testing
What is Iguratimod?
Iguratimod is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for arthritis, rheumatoid.
Also referred to as IGU, T-614.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- \- 1.Patients with RA who meet ACR 1987 rheumatoid arthritis classification criteria or ACR/EULAR 2010 rheumatoid arthritis Classification Criteria...
- 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)
You likely can't join if
- Patients with combined active hepatitis
- Patients with active tuberculosis
- Patients withinfection and malignancy
See the full eligibility 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.
- 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 a. Knee pain most of the...
- Patients with combined active hepatitis
- Patients with active tuberculosis
- Patients withinfection and malignancy
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.