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Study on the Effectiveness of Ixekizumab for Patients with Refractory Psoriatic Arthritis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Psoriatic Arthritis, a condition that causes joint pain and swelling in people who have psoriasis, a skin disease. The treatment being tested in this study is called Ixekizumab, which is given as a solution for injection using a pre-filled syringe. The study aims to find out if certain changes in the body can predict how well patients with difficult-to-treat psoriatic arthritis will respond to this treatment.

Participants in the study will receive Ixekizumab and will be monitored over a period of time to see how their condition changes. The study will look at how the treatment affects the joints and overall symptoms of the disease. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment. The main goal is to see if the treatment helps reduce the symptoms of psoriatic arthritis after 12 weeks.

Throughout the study, various tests and assessments will be conducted to measure the response to the treatment. These include checking the number of swollen and tender joints, as well as using imaging techniques to look at the joints. The study will also evaluate other aspects of the disease, such as pain levels and physical function, to get a comprehensive understanding of how Ixekizumab works in treating psoriatic arthritis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide written informed consent. This means you agree to participate in the study after understanding all the details and potential risks involved.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your diagnosis of psoriatic arthritis. This will involve a physical examination by a physician to ensure you meet the study criteria, such as having active disease with three or more swollen and tender joints.
Step 3
Synovial biopsy
A synovial biopsy will be performed on one of your affected joints. This procedure involves taking a small sample of tissue from the joint lining to study biomarkers, which are indicators of how your body is responding to the treatment.
Step 4
Medication administration
You will receive the medication ixekizumab, known by the brand name Taltz. This medication is administered as a subcutaneous injection, which means it is injected under the skin. The dosage is 80 mg, and the frequency and duration of administration will be determined by the study protocol.
Step 5
Ongoing assessments
Throughout the study, regular assessments will be conducted to monitor your response to the treatment. These assessments will include physical examinations and possibly additional imaging tests to evaluate changes in your joints.
Step 6
Primary endpoint evaluation
At 12 weeks, the primary endpoint of the study will be evaluated. This involves measuring your response to the treatment using the ACR20 criteria, which assesses improvements in joint symptoms.
Step 7
Secondary endpoint evaluation
Secondary endpoints will also be evaluated at 12 and 24 weeks. These include various measures of joint health and overall well-being, such as the PsASon22 score, which uses ultrasound to assess joint inflammation.

Who can join the trial?

9 criteria

Have a confirmed diagnosis of Psoriatic Arthritis (PsA), which is a type of arthritis that affects some people with the skin condition psoriasis.
Be 18 years of age or older.
Have active disease, which means having 3 or more swollen joints and 3 or more tender joints.
Have a potential need for a new type of medication called bDMARD therapy with a drug named IXE, as determined by your doctor.
Have tried at least one previous treatment called csDMARDs (conventional synthetic Disease-Modifying Anti-Rheumatic Drugs) without success, either due to incomplete response, loss of effectiveness, or side effects. You should not have used b/tsDMARDs (biologic/targeted synthetic DMARDs) before.
Have at least one joint that can be used for a procedure called a US-guided synovial biopsy, which is a way to take a small sample of tissue from the joint using ultrasound guidance.
Be willing to provide written informed consent, which means you agree to participate in the study after understanding all the details.
If taking oral prednisone, a type of steroid medication, the dose should be 10 mg per day or less and stable for at least 4 weeks.
Not be taking any other csDMARDs, or if you are, the dose should be stable for at least 4 weeks.

Who cannot join the trial?

10 criteria

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of allergic reactions to the study medication.
Patients with active infections that require treatment.
Patients with a history of cancer within the last 5 years, except for certain skin cancers.
Patients with liver disease or abnormal liver function tests.
Patients with kidney disease or abnormal kidney function tests.
Patients with a history of drug or alcohol abuse within the last year.
Patients who are unable to comply with the study procedures.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Sanitaria Universitaria Friuli Centrale
Verified
Udine, Italy
Fondazione IRCCS San Gerardo Dei Tintori
Verified
Monza, Italy
Universita' Degli Studi Di Ferrara
Verified
Ferrara, Italy

Trial locations

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Investigated drugs

Ixekizumab is a medication used in this clinical trial to help people with psoriatic arthritis, a condition that causes joint pain and swelling. This medication works by targeting a specific protein in the body that is involved in inflammation. By blocking this protein, ixekizumab can help reduce the symptoms of psoriatic arthritis, such as pain and swelling, and improve the overall quality of life for patients. In this study, researchers are looking at how changes in certain markers in the body, called synovial biomarkers, can predict how well patients will respond to treatment with ixekizumab over a period of 12 weeks.

Ixekizumab

What is already known about the treatment

Ixekizumab – Ixekizumab is administered as an injection under the skin, typically in the form of a pre-filled syringe or auto-injector. It is currently being studied for its effectiveness in treating psoriatic arthritis, particularly in patients who have not responded well to other treatments. The main therapeutic use of Ixekizumab is to reduce inflammation and improve symptoms in individuals with psoriatic arthritis. At the molecular level, Ixekizumab works by targeting and neutralizing a specific protein in the body called interleukin-17A, which plays a key role in the inflammatory process. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the immune system.

Investigated diseases

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects the joints and is associated with psoriasis, a skin disease. It typically causes joint pain, stiffness, and swelling, which can vary in severity. The disease often progresses with periods of flare-ups and remissions. Over time, it can lead to joint damage and reduced mobility if not managed properly. The inflammation can also affect other parts of the body, including the eyes and the spine. The progression of symptoms can differ greatly among individuals, with some experiencing mild symptoms and others facing more severe joint involvement.