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Tests treatment safety and results for Rheumatoid Arthritis
Official title A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT07276581
What this study is testing
What is AZD1163?
AZD1163 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for rheumatoid arthritis.
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
- Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Inclusion
- Diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior to screening.
- Moderately-to-severely active RA as defined by: a. \>= 6 swollen joints on 66SJC and \>= 6 tender joints on 68TJC; b. CRP \> upper limit of normal.
- Have a positive ACPA at screening.
- A history of inadequate response, or loss of response, or intolerance to: a. at least one csDMARD treatment, AND/OR b. At least one and at most 2...
See the full eligibility criteria
- Inclusion
- Diagnosed with adult-onset RA as defined by the 2010 ACR/EULAR classification criteria for at least 12 weeks prior to screening.
- Moderately-to-severely active RA as defined by: a. \>= 6 swollen joints on 66SJC and \>= 6 tender joints on 68TJC; b. CRP \> upper limit of normal.
- Have a positive ACPA at screening.
- A history of inadequate response, or loss of response, or intolerance to: a. at least one csDMARD treatment, AND/OR b. At least one and at most 2 TNFi.
- A history of at least 12 weeks treatment and \>= 4 weeks stable on a csDMARD and/or SC TNFi prior to the day of randomisation.
- Exclusion
- History or evidence of an alternate autoimmune or other condition that could confound the diagnosis of RA. Participants with RA and secondary Sjogren's disease are eligible.
- Have received or planning to receive any biologic DMARDs (except for TNFi) or targeted synthetic DMARDs.
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, Arizona, United States
- Prescott Valley, Arizona, United States
- Tucson, Arizona, United States
- La Jolla, California, United States
- San Dimas, California, United States
- San Leandro, California, United States
- Aurora, Colorado, United States
- Boynton Beach, Florida, United States
- Jacksonville, Florida, United States
- South Miami, Florida, United States
- Tampa, Florida, United States
- Winter Haven, Florida, United States
- Marietta, Georgia, United States
- Skokie, Illinois, United States
- Willowbrook, Illinois, United States
- Lake Charles, Louisiana, United States
- Baltimore, Maryland, United States
- New Bedford, Massachusetts, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
+ 102 more site(s).
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, Arizona, United States; Prescott Valley, Arizona, United States; Tucson, Arizona, United States; La Jolla, California, United States; San Dimas, California, United States; San Leandro, California, United States and 116 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.