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A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis

NCT07276581

RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Rheumatoid Arthritis

Interventions: AZD1163, Placebo

Countries: United States, Argentina, Brazil, Bulgaria, Canada, Chile, China, Germany

Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (144)
  • 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
  • Henderson, Nevada, United States
  • Myrtle Beach, South Carolina, United States
  • Austin, Texas, United States
  • Baytown, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • Mesquite, Texas, United States
  • Tomball, Texas, United States
  • Caba, Argentina
  • Ciudad de Buenos Aires, Argentina
  • + 114 more on CT.gov