A study to evaluate the effectiveness and safety of AZD1163 in adults with moderate to severe rheumatoid arthritis

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What is this study about?

This study investigates the efficacy and safety of a drug named AZD1163 in individuals living with Rheumatoid Arthritis. Rheumatoid Arthritis is a type of autoimmune disease where the body’s immune system mistakenly attacks the joints, causing swelling, pain, and stiffness. The research aims to see how well this new medication works compared to a placebo.

During the study, participants will receive either AZD1163 or a placebo through a subcutaneous injection, which is a method of delivering medicine into the fatty tissue just below the skin. This is a double-blind study, meaning that neither the participants nor the researchers will know which specific treatment is being administered until the study is completed. Participants will be divided into different groups to compare the effects of the active drug against the inactive substance.

Who Can Join the Study?

  • You must have been diagnosed with adult-onset rheumatoid arthritis, which is a type of long-term swelling and pain in the joints that starts in adulthood, for at least 12 weeks before the study begins.
  • Your disease must be moderately-to-severely active, meaning you have at least 6 swollen joints and 6 painful joints, and your CRP (a blood test that shows if there is inflammation or swelling in your body) is higher than the normal range.
  • You must test positive for ACPA, which is a specific type of antibody (a protein in the blood that helps the immune system) often found in people with this condition.
  • You must have a history of not getting enough help from, or having a bad reaction to, csDMARDs (traditional medicines used to slow down the disease) or TNFi (a specific type of medicine that targets inflammation).
  • You must have been taking csDMARDs or SC TNFi (medicine given by injection under the skin) for at least 12 weeks, and your dose must have stayed the same for at least 4 weeks before being assigned to a study group.
  • The study is open to both males and females.
  • You must fall within the specific age range required for this study.

Who Cannot Join the Study?

  • You cannot participate if you have a history or evidence of a different autoimmune condition, which is a disease where your body’s immune system mistakenly attacks your own healthy cells, if it could make it difficult to correctly diagnose rheumatoid arthritis.
  • People who have rheumatoid arthritis along with secondary Sjogren’s disease, a condition that causes dry eyes and mouth, are still allowed to join the study.
  • You cannot participate if you have taken or are planning to take any biologic DMARDs, which are powerful medicines used to slow down the immune system to treat diseases, unless it is a specific type called TNFi.
  • You cannot participate if you are planning to take targeted synthetic DMARDs, which are a specific type of medication designed to interfere with certain parts of the immune system.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Hospital Del Mar Barcelona Spain
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Qualiclinic Kft. Budapest Hungary
Malopolskie Badania Kliniczne Sp. z o.o. Cracow Poland
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Hamburg Germany
Complex Rendelo Med Zrt. Szekesfehervar Hungary
Rheumatologische Schwerpunktpraxis Berlin Germany
Mbal Lyulin EAD Sofia Bulgaria
University Of Debrecen Debrecen Hungary
St.-Josef-Stift Sendenhorst Germany
Semmelweis University Budapest Hungary
Universidade De Santiago De Compostela Santiago De Compostela Spain
Pratia S.A. Skorzewo Poland
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
University Of Szeged Szeged Hungary
Medici Sofia Medical Centre Ltd. Sofia Bulgaria
Vital Medical Center Veszprem Hungary
Mmgbfxouy Ihkgxnjhpb Cximuxqf Sdkgohcb Swp z orju Warsaw Poland
Hmrcomsf Upewmyrpsvhce Ryahrqju Dc Mfvomr Malaga Spain
Pnae Ttvhs Hvlijoxi Uyvnffmjfeqj Sabadell Spain
Bffacghlzp Isuybknoweww Bmovh Ioavwpyutpfne Kxxcqt Budapest Hungary
Mmtzajyp Moboslt Aiulipl Pleven Bulgaria
Hoyrvmbk Dk Ln Sxinw Chhb I Stqq Pzd Barcelona Spain
Rpfbgkyfcrb Sbjt Blwuhd Keajbvwowal Mbmil Zbsjhgye Wroclaw Poland
Hqhkysnq Vozn dtaaxked Barcelona Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
22.05.2026
Germany Germany
Not yet recruiting
22.05.2026
Hungary Hungary
Not yet recruiting
22.05.2026
Poland Poland
Not yet recruiting
22.05.2026
Spain Spain
Not yet recruiting
22.05.2026

Trial locations

AZD1163 is an experimental medication administered as an injection under the skin. This study is testing how well this drug works to treat people with moderate to severe rheumatoid arthritis.

Investigated diseases:

Rheumatoid arthritis – This is a chronic condition where the body’s immune system mistakenly attacks the lining of the joints. This process causes inflammation that leads to swelling and pain. Over time, the inflammation can cause the joint lining to thicken. This thickening can eventually damage the cartilage and bone within the joint. The condition often affects multiple joints at the same time, frequently starting in the smaller joints of the hands and feet.

Trial ID:
2025-522076-85-00
Protocol code:
D9640C00003
Trial Phase:
Therapeutic exploratory (Phase II)

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