Study on Reducing JAK Inhibitor Doses in Patients with Low Disease Activity in Rheumatoid Arthritis Using Tofacitinib and Drug Combination

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What is this study about?

This clinical trial is focused on studying rheumatoid arthritis, a condition that causes pain and swelling in the joints. The study will explore a treatment approach using medications known as JAK inhibitors. These medications include Tofacitinib, Filgotinib, Upadacitinib, and Baricitinib. The purpose of the study is to compare a strategy of gradually reducing the dose of these medications with continuing the current therapy in patients who have low disease activity, meaning their symptoms are well-controlled.

Participants in the study will be randomly assigned to either continue their current dose of JAK inhibitors or to gradually reduce their dose over a period of 12 months. The study will monitor whether patients maintain their low disease activity or experience a return of symptoms, known as a flare. If symptoms worsen, a rescue therapy will be provided. The study will also track other aspects such as pain levels, quality of life, and any side effects experienced by the participants.

The trial aims to understand if reducing the dose of JAK inhibitors can help maintain low disease activity without increasing the risk of flares. This could potentially lead to fewer side effects and lower medication costs for patients. The study will last for about a year, and the results will help doctors make informed decisions about the best treatment strategies for managing rheumatoid arthritis.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of rheumatoid arthritis, and current treatment with a JAK inhibitor for at least six months.

A negative pregnancy test is required for women of childbearing potential before starting the study.

2 initial assessment

An initial assessment is conducted to ensure the patient is in low disease activity, defined by a specific score (CDAI ≤ 10) for at least six months.

Blood tests are performed to confirm a CRP level below the laboratory standard.

3 treatment phase

Patients continue their current JAK inhibitor treatment, which may include medications such as tofacitinib, filgotinib, upadacitinib, or baricitinib, taken orally.

The study aims to compare a dose-tapering strategy versus continuing the current therapy over a 12-month period.

4 monitoring and assessments

Regular assessments are conducted to monitor disease activity using scores like CDAI, SDAI, and DAS28.

Patient-reported outcomes are collected, including pain, function, fatigue, and quality of life.

5 evaluation of flare-ups

The study evaluates the occurrence of flare-ups, defined by specific increases in disease activity scores.

The delay between the initial visit and the first flare-up is recorded.

6 final assessment

At the end of 12 months, the proportion of patients still in low disease activity is assessed.

The possibility of reducing the JAK inhibitor dosage in the dose-tapering group is evaluated.

7 conclusion of the study

The study concludes with a comprehensive analysis of the data collected over the 12-month period.

The impact of socioeconomic factors on care costs and efficiency is also examined.

Who Can Join the Study?

Must be 18 years or older.
Must have rheumatoid arthritis, which is a condition that causes joint pain and swelling, as defined by specific medical guidelines (ACR/EULAR criteria).
Must have been treated with a JAK inhibitor (a type of medication) at the full dose for at least 6 months.
The JAK inhibitor should be prescribed either alone or with another medication called a csDMARD (a type of drug used to treat rheumatoid arthritis) at a stable dose for at least 3 months before joining the study.
Must be in a state of low disease activity (LDA), which means the rheumatoid arthritis is not very active, for at least 6 months. This is measured by a score called CDAI that should be 10 or less.
Must have a CRP level (a blood test that measures inflammation) below the standard level set by the laboratory at the time of joining the study.
Women who can have children must have a negative pregnancy test before starting the study.

Who Cannot Join the Study?

Patients who do not have rheumatoid arthritis. This is a condition where the body’s defense system attacks its own joints, causing pain and swelling.
Patients who are not in the age range specified for the study. The study is open to certain age groups only.
Patients who are not currently experiencing low disease activity. This means their rheumatoid arthritis symptoms are not mild or under control.
Patients who are not being treated with JAK inhibitors. These are medications that help reduce inflammation and pain in rheumatoid arthritis.
Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Hopital Beaujon	Clichy	France
Groupement Des Hopitaux De L’Institut Catholique De Lille	lomme	France
Chjeei Hjhuaeogtfy Ualxpqjetvgqr Rahas	Reims	France
Cbakic Hycyxhcjqux El Unghynnbzqhuf Dh Lsbiuyb	Limoges	France
Anssbddzke Pzhpyogw Hdsvunas Do Mylwhnxmd	Marseille	France
Cdyhfw Hatvrfqhwjr Rgmdghek Uyzserainmhej Dc Txssk	Tours	France
Cpum Dr Namhi	Vandoeuvre Les Nancy	France
Gjlyhd Hrjwxfzzaie Uouvnswutyibz Porhg Ptflznthpbz Ei Nawvetugpxho	Paris	France
Irmditxb dj Cmvnhqyohref Hlzqjdfuobq Ugyzurkshpkke du Sjphw Edtiueu (torejpw	Saint Priest En Jarez	France
Htluipfw Uwtazasgokuopu Seuaqfthra &rwduru Hirerth du Hbjmelpndzi	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.05.2024

Trial locations

Investigated drugs:

JAK Inhibitors are medications used to treat rheumatoid arthritis by reducing inflammation and slowing down the progression of the disease. They work by blocking certain enzymes known as Janus kinases, which play a role in the inflammatory process. In this clinical trial, JAK inhibitors are being studied to see if patients with low disease activity can maintain their condition with a reduced dose, compared to continuing the full therapy.

Investigated diseases:

Rheumatoid arthritis

Rheumatoid arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the hands and feet. Over time, the inflammation can lead to joint damage and deformities. The disease can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. It progresses in a pattern of flares and remissions, where symptoms worsen and then improve. The exact cause is unknown, but it involves the immune system attacking the body’s own tissues.

Trial ID:

2023-509788-25-00

Protocol code:

RC31/23/0373

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reducing JAK Inhibitor Doses in Patients with Low Disease Activity in Rheumatoid Arthritis Using Tofacitinib and Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?