Not recruiting

Study on Tofacitinib for Achieving Remission in Early Psoriatic Arthritis Patients Without Prior DMARD Treatment

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 the effects of a medication called tofacitinib, also known by its code name CP-609,550, in treating a condition called Psoriatic Arthritis (PsA). Psoriatic Arthritis is a type of arthritis that affects some people who have the skin condition psoriasis. The medication being tested, tofacitinib, is taken in the form of film-coated tablets and is designed to help reduce inflammation and improve symptoms in patients with this condition.

The purpose of the study is to evaluate how well tofacitinib can help patients achieve and maintain remission, which means a period where symptoms are reduced or disappear. The study will also look at how patients do after stopping the medication. Participants in the study will take tofacitinib and will be monitored over a period of time to see how their condition changes. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active ingredient.

Throughout the study, participants will have regular check-ups to assess their symptoms and overall health. The study will track the number of patients who reach remission at different points, such as 24 weeks, and will also look at how long patients can stay in remission without medication. The study aims to provide valuable information on the effectiveness of tofacitinib in managing Psoriatic Arthritis and improving the quality of life for those affected by this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The study begins with the administration of tofacitinib, which is the active ingredient in XELJANZ 5 mg film-coated tablets. This medication is taken orally.
The primary goal during this phase is to achieve clinical remission of psoriatic arthritis symptoms by week 24.
Step 2
Monitoring and assessment
Throughout the study, regular assessments are conducted to monitor the evolution of arthritis, dactylitis, enthesitis, and skin involvement. These assessments occur at weeks 4, 12, 24, 28, 52, 76, and 104.
Patient-reported outcomes are also evaluated at these intervals, focusing on physical functioning and health state profiles.
Step 3
Drug-free follow-up
After the initial treatment phase, the study observes the proportion of patients who maintain drug-free remission at weeks 52 and 104.
The time to relapse is documented for patients who experience a flare after stopping the medication.
Step 4
Long-term evaluation
The study continues to evaluate the percentage of patients achieving specific response criteria and minimal disease activity at various intervals up to week 104.
Radiographic progression is assessed at weeks 52 and 104 to determine any changes in joint structure.

Who can join the trial?

7 criteria

Must be **18 years or older**.
Must have a **clinical diagnosis of Psoriatic Arthritis (PsA)** made by a specialist called a rheumatologist. The diagnosis should meet specific criteria known as CASPAR.
PsA symptoms must have started **24 weeks or less** before the first screening visit.
Must have **active disease**, as determined by the rheumatologist.
Must have at least **one swollen joint** that can be used for a procedure called an ultrasound-guided synovial biopsy at the beginning of the study.
Women who can have children and men who can father children must use **adequate birth control** during the study and for **6 months** after the last dose of the study medication.
Must be **able and willing** to provide written consent and participate in the study.

Who cannot join the trial?

10 criteria

Patients who have previously been treated with DMARDs. DMARDs are medications used to slow down the progression of certain diseases.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to the study medication.
Patients who are currently participating in another clinical trial.
Patients who have a history of substance abuse or alcohol dependency.
Patients who have an active infection or a history of frequent infections.
Patients who have been vaccinated with a live vaccine within the last 4 weeks.
Patients who have a history of cancer, except for certain types of skin cancer.
Patients who have a history of blood disorders or problems with blood clotting.

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Verified sites

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Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

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Investigated drugs

Tofacitinib is a medication used in this clinical trial to investigate its effectiveness in achieving and maintaining remission in patients with psoriatic arthritis. It works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the inflammation process. By blocking these enzymes, tofacitinib helps reduce inflammation and other symptoms associated with psoriatic arthritis. The trial aims to evaluate how well tofacitinib can induce remission and maintain it, even after the treatment has stopped, in patients who have not previously been treated with disease-modifying antirheumatic drugs (DMARDs).

Tofacitinib

What is already known about the treatment

Tofacitinib – Tofacitinib is administered orally in tablet form. It is currently being studied for its effectiveness in treating psoriatic arthritis, particularly in achieving and maintaining disease remission. The medication works by inhibiting Janus kinases (JAKs), which are enzymes that play a role in the inflammatory process. By blocking these enzymes, tofacitinib helps reduce inflammation and alleviate symptoms associated with psoriatic arthritis. It is classified as a Janus kinase inhibitor, a type of medication used to manage autoimmune conditions.

Investigated diseases

Psoriatic Arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It typically occurs in individuals with psoriasis, a skin disease characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, often affecting fingers and toes, leading to a sausage-like appearance known as dactylitis. Enthesitis, or inflammation where tendons and ligaments attach to bone, is also common. Over time, psoriatic arthritis can lead to joint damage and reduced physical function. The severity and progression of symptoms can vary widely among individuals.