Study to Predict Tofacitinib Effectiveness in Psoriatic Arthritis Patients Using Tofacitinib, Methotrexate, and Folic Acid

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What is this study about?

This clinical trial is focused on studying the effectiveness of a medication called tofacitinib in treating psoriatic arthritis, a type of arthritis that affects some people with the skin condition psoriasis. The purpose of the study is to identify certain factors that might predict how well patients respond to treatment with tofacitinib. Tofacitinib is taken orally in the form of a tablet. Other medications involved in the study include methotrexate, which can be administered either as a tablet or as an injection, and etanercept, which is given as an injection.

Participants in the study will be divided into groups based on their previous treatment history. Some participants may have used medications like methotrexate, sulfasalazine, or leflunomide, while others may not have used these treatments before. The study will last for a period of 16 weeks, during which participants will receive either tofacitinib or a placebo. The researchers will collect various types of data, including clinical, molecular, and imaging information, to understand how these factors might influence the effectiveness of tofacitinib in treating psoriatic arthritis.

The main goal is to see if participants achieve what is known as Minimal Disease Activity by the end of the study. This means that the symptoms of psoriatic arthritis are significantly reduced. The study will also look at changes in certain clinical scores and molecular profiles before and after treatment. This research aims to improve understanding of how tofacitinib works and to help doctors predict which patients are most likely to benefit from this treatment.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current medication use.

Eligibility criteria include being between 18-75 years old, having a diagnosis of psoriatic arthritis, and meeting specific clinical criteria such as having at least two swollen and tender joints.

2 medication administration

Participants are assigned to receive specific medications based on their treatment group. The main medication used in the study is tofacitinib, administered orally in the form of 5 mg film-coated tablets.

Other medications may include methotrexate in tablet form or as an injection, and etanercept as a solution for injection. Dosages and administration routes vary depending on the specific treatment plan.

3 treatment duration

The treatment phase lasts for 16 weeks. During this period, participants continue their assigned medication regimen and attend regular follow-up visits to monitor progress and any side effects.

4 monitoring and evaluation

Throughout the trial, participants undergo various assessments to evaluate the effectiveness of the treatment. This includes clinical evaluations, blood tests, and imaging studies.

The primary goal is to achieve Minimal Disease Activity (MDA) by week 16. Secondary evaluations include changes in clinical disease activity scores and individual clinical parameters.

5 final assessment

At the end of the 16-week treatment period, a final assessment is conducted to determine the overall response to the treatment. This includes a comprehensive review of clinical outcomes and any changes in disease activity.

Who Can Join the Study?

Age between 18 and 75 years old.
For the group currently using certain medications (csDMARD-IR group):

Currently using methotrexate, sulfasalazine, or leflunomide at the highest dose they can handle, and have been on a stable dose for at least 4 weeks before joining the study. The maximum doses are 25 mg per week for methotrexate, 20 mg per day for sulfasalazine, and 3000 mg per day for leflunomide.
Can have used only one type of biological medication (bDMARD) before joining, except:

Cannot have used etanercept.
Cannot have had a complete non-response to other TNF inhibitors (adalimumab, golimumab, infliximab, certolizumab) at the start. However, if they initially responded but then stopped responding to their first TNF inhibitor, they can join.

Cannot have used targeted synthetic medications (tsDMARD) like JAK inhibitors or abatacept.

Must meet the CASPAR criteria for psoriatic arthritis. CASPAR is a set of guidelines used to diagnose psoriatic arthritis.
Must have had the disease for at least 8 weeks.
Must show signs of active arthritis, which means having at least 2 swollen joints and 2 tender joints.
Must stop any active treatment for psoriasis before joining the study.
For the group that has not used certain medications before (csDMARD-naïve group):

Must not have a history of using csDMARD or bDMARD therapies.

Who Cannot Join the Study?

Patients who have previously used DMARDs (Disease-Modifying Anti-Rheumatic Drugs) and did not respond to them.
Patients who are currently using DMARDs.
Patients with medical conditions other than psoriatic arthritis that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of severe allergic reactions to medications.
Patients with active infections that require treatment.
Patients with significant liver or kidney disease.
Patients with a history of cancer, except for certain types of skin cancer.
Patients with a history of heart disease or stroke.
Patients with uncontrolled high blood pressure.
Patients with a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Stichting Viecuri Medisch Centrum voor Noord-Limburg	Venlo	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Rhnou rbpnowqjkve &matw rldyjwwiboqi cuzcwsf tg Asfamxren	Amsterdam	The Netherlands
Sml Efsooatkg Hyzmvqnt Tybruev	Tilburg	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	30.05.2018

Trial locations

Investigated drugs:

Tofacitinib is a medication used in this clinical trial to treat patients with Psoriatic Arthritis (PsA). It works by targeting specific pathways in the immune system to reduce inflammation and improve symptoms in patients who have not responded to other treatments. The trial aims to identify which patients are most likely to benefit from this medication by analyzing various biological data before treatment.

Psoriatic arthritis – Psoriatic arthritis is a chronic inflammatory condition that affects both the skin and joints. It is associated with psoriasis, a skin disease characterized by red, scaly patches. The disease can cause joint pain, stiffness, and swelling, which may lead to joint damage over time. Symptoms often vary in severity and can affect any joint in the body, including the spine and fingers. The progression of psoriatic arthritis can be unpredictable, with periods of increased symptoms followed by times of remission. It is important to monitor the condition to manage symptoms effectively.

Trial ID:

2024-510903-12-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study to Predict Tofacitinib Effectiveness in Psoriatic Arthritis Patients Using Tofacitinib, Methotrexate, and Folic Acid

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?