A study to investigate how well and safe a trial drug called AZD1163, administered as an injection, works in improving symptoms and inflammation in adult participants with moderately to severely active rheumatoid arthritis.
Key facts
- Where
- Budapest, Budapest II, Debrecen, Gyula, Szeged, Székesfehérvár és Veszprem, MagyarországSee the 8 sites
- Phase
- 2. fázis
Where in Magyarország
- Qualiclinic Kft.Budapest, MagyarországTaking people
- Semmelweis UniversityBudapest, MagyarországTaking people
- Betegapolo Irgalmasrend Budai Irgalmasrendi KorhazBudapest II, MagyarországTaking people
- University of DebrecenDebrecen, MagyarországTaking people
- Bekes Varmegyei Koezponti KorhazGyula, MagyarországTaking people
- University of SzegedSzeged, MagyarországTaking people
- Complex Rendelo Med Zrt.Székesfehérvár, MagyarországTaking people
- Vital-Medicina Kft.Veszprem, MagyarországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2025-522076-85-00
- Record updated
- 2026. október 7.
- Original description
To evaluate the clinical efficacy of AZD1163 as compared to placebo.Read full original descriptionShow less
A Multicentre, Parallel-group, Phase II, Randomised, Double-blind, 4 Arm Study to Evaluate Efficacy and Safety of AZD1163 in Participants with Moderately-to-Severely Active Rheumatoid Arthritis (LaunchPAD-RA)
To evaluate the clinical efficacy of AZD1163 as compared to placebo.
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: Have received or planning to receive any biologic DMARDs (except for TNFi) or targeted synthetic DMARDs; 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.