A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
Recruiting · NCT07276581 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
AZD1163Placebo
What this trial is about
Phase II study in participants with moderately-to-severely active rheumatoid Arthritis (RA) to evaluate efficacy and safety of AZD1163.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
* 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.
Where it is running
60 locations listed across 13 US states.
- Research Site - Glendale, Arizona, United States
- Research Site - Prescott Valley, Arizona, United States
- Research Site - Tucson, Arizona, United States
- Research Site - La Jolla, California, United States
- Research Site - San Dimas, California, United States
- Research Site - San Leandro, California, United States
- Research Site - Aurora, Colorado, United States
- Research Site - Boynton Beach, Florida, United States
- Research Site - Jacksonville, Florida, United States
- Research Site - South Miami, Florida, United States
- Research Site - Tampa, Florida, United States
- Research Site - Winter Haven, Florida, United States
- Research Site - Marietta, Georgia, United States
- Research Site - Skokie, Illinois, United States
- Research Site - Willowbrook, Illinois, United States
- Research Site - Lake Charles, Louisiana, United States
- Research Site - Baltimore, Maryland, United States
- Research Site - New Bedford, Massachusetts, United States
- Research Site - Kansas City, Missouri, United States
- Research Site - St Louis, Missouri, United States
- Research Site - Henderson, Nevada, United States
- Research Site - Myrtle Beach, South Carolina, United States
- Research Site - Austin, Texas, United States
- Research Site - Baytown, Texas, United States
- Research Site - Houston, Texas, United States
- Research Site - Houston, Texas, United States
- Research Site - Mesquite, Texas, United States
- Research Site - Tomball, Texas, United States
- Research Site - Aomori, Japan
- Research Site - Bad Doberan, Germany
- Research Site - Barcelona, Spain
- Research Site - Barcelona, Spain
- Research Site - Barcelona, Spain
- Research Site - Beijing, China
- Research Site - Beijing, China
- Research Site - Berlin, Germany
- Research Site - Brackenfell, South Africa
- Research Site - Budapest, Hungary
- Research Site - Budapest, Hungary
- Research Site - Budapest, Hungary
- Research Site - Bunkyō City, Japan
- Research Site - Caba, Argentina
- Research Site - Caguas, Puerto Rico
- Research Site - Cape Town, South Africa
- Research Site - Changchun, China
- Research Site - Changsha, China
- Research Site - Chihuahua City, Mexico
- Research Site - Ciudad de Buenos Aires, Argentina
- Research Site - Ciudad de Buenos Aires, Argentina
- Research Site - Córdoba, Argentina
- Research Site - Debrecen, Hungary
- Research Site - Durban, South Africa
- Research Site - Estado de México, Mexico
- Research Site - Fukuoka, Japan
- Research Site - Glasgow, United Kingdom
- Research Site - Guadalajara, Mexico
- Research Site - Guadalajara, Mexico
- Research Site - Guadalajara, Mexico
- Research Site - Guangzhou, China
- Research Site - Gustavo A. Madero, Mexico
Showing 60 of 144 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →