Expired Study
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Clinical Trial 10389

Daytona Beach, FL 32117


Study Summary:

Do you have rheumatoid arthritis?
Are you taking a rheumatoid arthritis medication but still have painful, swollen and stiff joints?


If so, you may be eligible to participate in a clinical research program evaluating a new investigational medication for rheumatoid arthritis. The symptoms of rheumatoid arthritis (joint pain, swelling, and stiffness) can be long lasting and can affect your ability to carry out daily activities. In the OSKIRA Program, clinical research studies look at whether a new investigational medication is effective and safe in the treatment of rheumatoid arthritis, when given in combination with your regular rheumatoid arthritis medication. The investigational medication is in tablet form and is taken orally (by mouth).

The OSKIRA program is sponsored by AstraZeneca.

What is the purpose of the OSKIRA Program?

Although there is currently no cure for rheumatoid arthritis, treatment can improve symptoms. Available treatments include those that help to reduce pain and inflammation (such as painkillers and anti-inflammatory agents) and those that help to slow down joint damage and ease symptoms (disease-modifying anti-rheumatic drugs [DMARDs] such as methotrexate, and anti-tumor necrosis factor-alpha [TNF-α] medications). Not all patients respond to the treatments that are currently available, so scientists and doctors have been looking for alternative treatment options.

What is the OSKIRA Program?

The OSKIRA Program is looking at whether a new investigational medication is effective and safe in the treatment of rheumatoid arthritis when given in combination with your regular rheumatoid arthritis medication. The program will involve patients who have rheumatoid arthritis symptoms despite taking another regular medication. The OSKIRA Program involves people with rheumatoid arthritis from around the world.

What will taking part in the OSKIRA Program involve?

There are three parts to each study within the OSKIRA Program:

Screening: The first step will be a visit to the study center so your study doctor can check if you are eligible to join. The study will be explained to you in full detail and you will be asked to sign an informed consent document acknowledging that you understand the study procedures and agree to take part. You can decide to leave the study at any time.

Treatment period: In addition to your regular rheumatoid arthritis medication, your study doctor will prescribe the investigational medication to take for either 24 or 52 weeks (depending which study you are taking part in). The type of investigational medication you receive (active treatment or placebo - a dummy tablet that contains no active medication) will be decided at random and neither you nor the study staff will know which you are receiving. If you are taking placebo and are enrolled into the 52 week study, you will be switched to active investigational medication at week 24 (however this information will not be revealed to you or your study doctor).

Follow-up: You will have a scheduled visit at the study center to see how you are once you have stopped taking the investigational medication.

The study will require 13 or 21 scheduled visits to the study center (depending on which study you are taking part in). During these visits you will have several assessments to monitor your rheumatoid arthritis symptoms and general health, including blood tests, urine tests, X-rays, a physical examination, and an electrocardiogram (ECG - a painless test that records the heart’s electrical activity). A full study schedule will be provided to you before you agree to participate in this study.

While the study is taking place you will be treated, supported, and monitored carefully by a team of experienced doctors and nurses.

Once you have completed the treatment period, or if your rheumatoid arthritis does not respond to treatment by week 12, you may be given the opportunity to receive active investigational medication in an extension study.

Are there any risks or benefits to taking part in this study?

As with all medicines, you may experience side effects. The study doctor will talk you through the possible side effects in detail. However, while the study is taking place you will be treated, supported, and monitored carefully by a team of experienced doctors and nurses.

It is possible that the investigational medication could help your rheumatoid arthritis, but this cannot be guaranteed. Taking part in the study will provide new information that will add to the current knowledge about rheumatoid arthritis treatment, which may help other patients in the future. joomla site stats


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.