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Toward personalized medicine to guide drug withdrawal in children with juvenile idiopathic arthritis in clinical remission: a randomized clinical trial comparing early versus late drug withdrawal combining imaging and multi-Omics.
EU CTIS ID: 2024-514732-24-00
What this study is testing
To demonstrate that early biomarker-guided withdrawal of antirheumatic agents in JIA patients achieving 6 months clinical inactive disease (CID) with medication and who do not have subclinical inflammation is safe and more effective when compared to the standard practice of maintenance of stable treatment intensity over 12 months.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Children with JIA according to the ILAR classification (Oligoarthritis, Rheumatoid factor negative polyarthritis, Rheumatoid factor positive polyarthritis, Psoriatic arthritis, Enthesitis-related arthritis)
- JIA patients who satisfy criteria for inactive disease for a minimum of 6 continuous months while still taking medication.
- JIA patients who are receiving cs/b/bs/tsDMARDs according to the label indication.
- Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and/or patients, as appropriate
- Duly executed, written, informed consent obtained from the patient’s parents/legal guardian.
- Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must have no intention of conceiving while on treatment with antirheumatic drugs
You likely can't join if
- Patients with systemic JIA according to ILAR criteria
- Patients with undifferentiated arthritis according to ILAR criteria
- Patients with severe disease-related ocular damage and who need systemic treatment for uveitis
- Patients who had received glucocorticoid treatment 3 months prior to baseline visit
- Patients who had previously unsuccessfully attempted tapering cs/b/bs/tsDMARDs
- Patients with severe damage as per caring physician measured
See the full eligibility criteria
- Children with JIA according to the ILAR classification (Oligoarthritis, Rheumatoid factor negative polyarthritis, Rheumatoid factor positive polyarthritis, Psoriatic arthritis, Enthesitis-related arthritis)
- JIA patients who satisfy criteria for inactive disease for a minimum of 6 continuous months while still taking medication.
- JIA patients who are receiving cs/b/bs/tsDMARDs according to the label indication.
- Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and/or patients, as appropriate
- Duly executed, written, informed consent obtained from the patient’s parents/legal guardian.
- Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must have no intention of conceiving while on treatment with antirheumatic drugs
- Patients with systemic JIA according to ILAR criteria
- Patients with undifferentiated arthritis according to ILAR criteria
- Patients with severe disease-related ocular damage and who need systemic treatment for uveitis
- Patients who had received glucocorticoid treatment 3 months prior to baseline visit
- Patients who had previously unsuccessfully attempted tapering cs/b/bs/tsDMARDs
- Patients with severe damage as per caring physician measured
- Prior or current history of other significant concomitant illness(es) that, according to the Investigator’s judgment, would adversely affect the patient’s participation in the study. These include, but are not limited to gastrointestinal, hepatobiliary, pulmonary, nonmalignant lymphoproliferative diseases, other lymphatic disease(s), psychiatric disorders, history of inflammatory bowel disease, or previous gastrointestinal perforation, etc.
- Pregnant and breastfeeding individuals
- Participation in other interventional clinical trials for the entire duration of the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.