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New treatment option for Rheumatoid Arthritis (RA)
Official title A Phase 1 Study of ADI-001 in Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT07100873
What this study is testing
What is ADI-001?
ADI-001 is an investigational medicine, being studied as a potential treatment for rheumatoid arthritis (ra).
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
- ADI-001-106 is a phase 1 study of ADI-001 with a randomized, single-blind, parallel group design to compare two different LD regimens in subjects with treatment-refractory RA. The study will consist of different periods including screening, LD, treatment, and follow-up
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- ≥ 18 years of age.
- Fulfills the 2010 ACR-EULAR RA classification criteria
- Agreement not to take traditional medicines and medications not prescribed by a doctor
- Adequate hematological, liver, cardiac and pulmonary function
You likely can't join if
- Presence of severe liver disease, Child-Pugh class B or C.
- Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent).
- people unwilling to participate in an extended safety monitoring period (LTFU protocol)
- History of a clinically significant infection (including sepsis, pneumonia, bacteremia, fungal, viral and opportunistic infections) within 4 weeks...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 Shanghai, Shanghai Municipality, 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.