Taking people in GermanyPhase 2
Tests AZD1163 injection in adults with active rheumatoid arthritis
Tests the injected drug AZD1163 against placebo in adults with active rheumatoid arthritis.
Key facts
- Who runs it
- AstraZeneca AB
- Where
- Berlin, Hamburg, and Sendenhorst, GermanySee the 3 sitesAlso in 4 other countries, 27 sites
- Trial code
- Registry title
- 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.
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 97 people, planned
- Started
- 17 Jul 2026
- Expected to end
- 18 Aug 2028
- Type of study
- Interventional
- Record updated
- 7 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with moderately to severely active rheumatoid arthritis who did not respond well to earlier treatment and have a positive ACPA test.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Adult-onset rheumatoid arthritis, diagnosed at least 12 weeks before screening. The disease must be moderately to severely active: at least 6 swollen joints, at least 6 tender joints, and CRP above the upper limit of normal.
- Earlier treatment
- Must have had an inadequate response, loss of response or intolerance to at least one csDMARD and/or at least one and at most 2 TNFi. Must have been treated for at least 12 weeks, stable for at least 4 weeks on a csDMARD and/or SC TNFi before randomisation.
- Biomarker or test result
- A positive ACPA at screening.
Main reasons for not taking part
- Another autoimmune or other condition that could confuse the rheumatoid arthritis diagnosis (secondary Sjogren's disease is allowed)
- Has received or plans to receive any biologic DMARD other than a TNFi
- Has received or plans to receive any targeted synthetic DMARD
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Germany
Also in 4 other countries, 27 sites
- Rheumatologische SchwerpunktpraxisBerlin, GermanyTaking people
- MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbHHamburg, GermanyTaking people
- St. Josef Stift GmbHSendenhorst, GermanyTaking people
About the trial
What the trial wants to find out
To evaluate the clinical efficacy of AZD1163 as compared to placebo.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Tests AZD1163 injection in adults with active rheumatoid arthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 7 October 2026