A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis
This research study is looking for people with moderate to severe rheumatoid arthritis (RA) to test a new medicine called AZD1163. RA is a long-lasting condition that causes pain, swelling, and stiffness in the joints. The new medicine is designed to work differently from current treatments by targeting specific proteins linked to RA. This study will compare AZD1163 to a dummy medicine (placebo) to see if it can improve symptoms and is safe to use. Participants will continue their usual RA treatment alongside the study medicine. It's a 'Phase 2' study, meaning it's an early stage of testing this new medicine in a larger group of people.
Överblick
Vad handlar denna studie om?
This study is about exploring a new potential treatment, called AZD1163, for people living with rheumatoid arthritis (RA). RA is an autoimmune condition where your body's immune system mistakenly attacks your joints, leading to pain, swelling, and stiffness. We're looking for individuals whose RA symptoms are still bothering them despite trying other common medications.
AZD1163 is a new type of medicine that works in a different way to tackle RA. It's designed to block certain enzymes in the body that are thought to play a part in causing RA symptoms. By doing this, researchers hope it might help to reduce the inflammation and damage in the joints.
This is a 'Phase 2' study, which means it's an important step in developing new medicines. We're trying to learn more about how well AZD1163 works, what the right dose might be, and if it's safe for people to use. Information from this study will help us understand if AZD1163 could become a new treatment option for RA in the future.
Viktiga punkter
- This study is testing a new medicine (AZD1163) for moderate to severe rheumatoid arthritis.
- It's for people whose current RA treatments haven't worked well enough.
- Participants will continue their usual RA medication alongside the new treatment or a placebo.
- The study assesses safety and how well the new medicine reduces RA symptoms.
- Participation involves regular clinic visits and treatment for about 24 weeks, followed by 28 weeks of safety monitoring.
Vem kan vara berättigad?
This study is looking for adults aged 18 or older who have been diagnosed with rheumatoid arthritis for at least 12 weeks. Your RA symptoms should be at a moderate to severe level, meaning you have a certain number of swollen and tender joints, and blood tests show signs of inflammation. Importantly, you should have a specific type of antibody in your blood related to RA, called ACPA.
To be considered, you must have tried other RA treatments in the past, but they either didn't work well enough, stopped working, or you couldn't tolerate them. This includes at least one common RA medicine (like methotrexate) and/or one or two types of biologic medicines called TNF inhibitors. You also need to have been on your current regular RA treatment for at least 12 weeks and have been taking a stable dose for at least 4 weeks before joining.
However, you cannot join if you have another serious autoimmune condition that might make your RA diagnosis unclear, or if you're planning to take or are currently taking certain other biologic or targeted synthetic RA medications (apart from TNF inhibitors).
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Är du 18 år eller äldre?
- Have you been diagnosed with rheumatoid arthritis for at least 12 weeks?
- Are your RA symptoms currently moderate to severe?
- Have you tried at least one 'conventional' RA medicine (e.g., methotrexate) and/or one or two TNF inhibitor medicines (e.g., adalimumab, etanercept) that didn't work well enough?
- Are you currently on a stable dose of your regular RA medication?
- Do you have a specific antibody (ACPA) linked to RA in your blood?
Vad innebär deltagande?
If you join the study, you'll first go through a screening period to check if you meet all the requirements. If you do, you'll be randomly assigned to one of four groups. Three groups will receive different doses of the new medicine, AZD1163, given as an injection under the skin. The fourth group will receive a 'placebo', which is a dummy injection with no active medicine. You will continue to take your usual RA medication alongside the study treatment.
The study medicine or placebo will be given until Week 24. After this, there will be a follow-up period of 28 weeks where researchers will continue to monitor your health and safety. The total duration of your participation, including screening, treatment, and follow-up, will be around 52 weeks (about a year). Throughout this time, you will have regular visits to the clinic for assessments, including physical exams, blood tests, and discussions about your symptoms and how you're feeling.
Potentiella risker och fördelar
Platser (147)
- ForskningsplatsVerifierat postnummerGlendale, USA· Rekrytering
- ForskningsplatsVerifierat postnummerPrescott Valley, United States· Återkallad
- ForskningsplatsVerifierat postnummerTucson, USA· Rekrytering
- ForskningsplatsVerifierat postnummerLa Jolla, USA· Rekrytering
- ForskningsplatsVerifierat postnummerSan Dimas, USA· Återkallad
- ForskningsplatsVerifierat postnummerSan Leandro, United States· Rekrytering
- ForskningsplatsVerifierat postnummerAurora, USA· Rekrytering
- ForskningsplatsVerifierat postnummerBoynton Beach, United States· Återkallad
- ForskningsplatsVerifierat postnummerJacksonville, USA· Återkallad
- ForskningsplatsVerifierat postnummerSouth Miami, United States· Avstängd
- ForskningsplatsVerifierat postnummerTampa, USA· Återkallad
- ForskningsplatsVerifierat postnummerWinter Haven, United States· Rekrytering
Vanliga frågor
What is rheumatoid arthritis?
Rheumatoid arthritis (RA) is a long-term condition that causes pain, swelling, and stiffness in the joints. It happens when your body's immune system mistakenly attacks its own tissues.
What does 'Phase 2' mean for a clinical trial?
Phase 2 means this is an early stage of testing where the new medicine is given to a larger group of people (usually a few hundred) to see if it works, find the right dose, and check for side effects.
Will I know if I'm getting the new medicine or a dummy medicine?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know if you're receiving AZD1163 or the placebo. This helps ensure unbiased results.
Do I stop my current RA medication if I join the study?
No, you will continue your current regular RA medication (standard of care) alongside the study medicine throughout the treatment period.
How is the new medicine given?
The new medicine, AZD1163, is given as an injection under the skin (subcutaneous injection).
Hur du får reda på mer
AstraZeneca Klinisk Studie Informationscenter
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