Rheumatoid Arthritis
Conditions
Interventions
Experimental: AZD1163 Dose 1
Participants will receive subcutaneous (SC) injection of AZD1163 Dose 1 in combination with SoC (csDMARDs or TNFi +/- csDMARD) until Week 24.
Drug: AZD1163
- Participants
Sponsors
Ageishi Yuji
Eligibility
Inclusion criteria
Inclusion criteria: - 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 criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) at Week 12 [Time Frame: Week 12] Change from baseline in DAS28-CRP at Week 12. | — |
Countries
Argentina, Brazil, Bulgaria, Canada, Chile, China, Germany, Hungary, Japan, Mexico, Poland, South Africa, Spain, the United Kingdom, the United States, Ukraine
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed