Study Comparing Step-up and Step-down Treatment Strategies with Methotrexate and Etanercept for Children with Juvenile Idiopathic Arthritis

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What is this study about?

This clinical trial is focused on studying juvenile idiopathic arthritis, a type of arthritis that affects children. The study will explore two different treatment strategies to manage this condition. One strategy involves gradually increasing the treatment intensity, known as the “Step-up” approach, while the other involves starting with a more aggressive treatment plan, called the “Step-down” approach. The treatments being tested include a combination of conventional and biological medications. The conventional medication used in this study is methotrexate, which is a chemical substance, and the biological medication is etanercept, a protein-based treatment.

The purpose of the study is to compare the effectiveness of these two treatment strategies in achieving clinical remission, which means the absence of active disease symptoms, over a period of 12 months. Participants in the study will receive either the Step-up or Step-down treatment plan, and their progress will be monitored to see which approach is more effective in managing the symptoms of juvenile idiopathic arthritis. The study will also look at how many patients achieve a state of inactive disease at any point during the study.

Participants will be children newly diagnosed with juvenile idiopathic arthritis who have not previously been treated with disease-modifying antirheumatic drugs (DMARDs), except for one non-steroidal anti-inflammatory drug (NSAID). The study will last for a maximum of six months for each participant, and the treatments will be administered through subcutaneous injections, which means the medication is injected under the skin. The trial aims to provide valuable insights into the best treatment strategies for managing juvenile idiopathic arthritis in children.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A pregnancy test is required for females of child-bearing potential. Consent forms must be signed by the patient or their guardians.

2 randomization

Participants are randomly assigned to one of two treatment strategies: Step-up or Step-down.

The Step-up strategy involves starting with a lower intensity treatment and increasing as needed. The Step-down strategy begins with a more aggressive treatment approach.

3 treatment administration

For the Step-up strategy, treatment begins with methotrexate administered subcutaneously using Reumaflex 50 mg/ml solution in a pre-filled syringe.

For the Step-down strategy, a combination of methotrexate and etanercept is used. Etanercept is administered subcutaneously using Enbrel 25 mg or 50 mg solution in a pre-filled syringe, depending on the dosage required.

4 monitoring and follow-up

Regular follow-up visits are scheduled to monitor the patient’s response to treatment and adjust dosages if necessary.

The primary goal is to achieve clinical remission, which means the absence of active arthritis symptoms, within 12 months.

5 evaluation of outcomes

The effectiveness of the treatment strategies is evaluated by comparing the rate of patients achieving remission or a state of inactive disease.

The study aims to determine which strategy is more effective in managing juvenile idiopathic arthritis.

Who Can Join the Study?

Children who have been newly diagnosed with juvenile idiopathic arthritis (JIA) and have not been treated with synthetic or biological DMARDs (disease-modifying antirheumatic drugs). Only treatment with one NSAID (non-steroidal anti-inflammatory drug) is allowed, and no corticosteroid joint injections before joining the study.
Children must have active arthritis, which means their joints are currently inflamed or swollen.
The symptoms of JIA must have started no more than 6 months before joining the study.
Children must be between the ages of 2 and 16 years old when they join the study.
Girls who can have children must have a negative pregnancy test at the start of the study. If they are sexually active, they must agree to use very effective birth control during the study and must not plan to become pregnant. Boys who have gone through puberty must not plan to father a child during the study and must agree to use very effective birth control if sexually active.
The child and their parents must be able to follow all the study procedures, communicate well with the study staff, and be able to give written permission to participate in the study.
Written permission to participate in the study must be obtained from the parents and/or the child.

Who Cannot Join the Study?

Patients who have a different condition than juvenile idiopathic arthritis cannot participate. This condition is a type of arthritis that occurs in children.
Patients who are not within the specified age range for the study cannot participate. The study is for children aged 2 years and older.
Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
Patients who have other serious health conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had a recent infection or illness that could affect the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of allergic reactions to the study medications cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
IRCCS Istituto Giannina Gaslini	Genoa	Italy
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto	Milan	Italy
ARNAS Civico Di Cristina Benfratelli	Palermo	Italy
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo	Trieste	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti	Chieti	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita’ Di Pisa	Pisa	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Avacjke Ovgksopfjwf Ufxzlokcjnncm Ceuktmsfilhm Dyxch Sjeuwz E Dhzyy Sukspau Dq Tukrqy	Turin	Italy
Acjvtqh Ump Ixzio Dr Rbdkfw Esamoo	Reggio Emilia	Italy
Aqyhmpa Usoio Seyqmqcmo Lxbbhm Dg Bpfnppq	Bologna	Italy
Ubqyiaobhl Mtzjc Gmfzmet Os Coaajuhxg	Catanzaro	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	29.05.2019

Trial locations

Investigated drugs:

Methotrexate is a medication commonly used to treat arthritis by reducing inflammation and slowing down the progression of the disease. It is often the first choice in managing symptoms and is part of the conventional treatment strategy.

Etanercept is a biological medication that helps to reduce inflammation by targeting specific proteins in the immune system. It is used in combination with other treatments for a more aggressive approach to managing arthritis symptoms.

Adalimumab is another biological medication that works by blocking a protein in the body that causes inflammation. It is used to help control severe arthritis symptoms and is part of the early aggressive intervention strategy.

Sulfasalazine is a medication that helps to reduce inflammation and pain in the joints. It is often used in combination with other treatments to manage arthritis symptoms effectively.

Hydroxychloroquine is a medication that can help reduce inflammation and pain in arthritis. It is sometimes used as part of a combination therapy to improve the overall effectiveness of treatment.

Investigated diseases:

Juvenile idiopathic arthritis

Juvenile Idiopathic Arthritis – This is a type of arthritis that occurs in children under the age of 16. It is characterized by persistent joint inflammation, which can lead to pain, swelling, and stiffness. The disease can affect one or multiple joints and may also cause symptoms such as fever and rash. Over time, it can lead to joint damage and growth problems if not managed properly. The progression of the disease varies, with some children experiencing symptoms for only a few months, while others may have symptoms for many years. The exact cause is unknown, but it is believed to involve a combination of genetic and environmental factors.

Trial ID:

2023-505051-43-00

Protocol code:

The STARS trial

NCT ID:

NCT03728478

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Step-up and Step-down Treatment Strategies with Methotrexate and Etanercept for Children with Juvenile Idiopathic Arthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?