A Phase 4 interventional study of Treatment medication withdrawal strategy in Juvenile Idiopathic Arthritis (JIA), sponsored by Istituto Giannina Gaslini. Not yet recruiting at 1 site in Italy. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Istituto Giannina Gaslini · Phase 4, Interventional, and Treatment
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Among 56 studies in Arthritis, Juvenile with a site in Italy — 20 open to participants now, 24 under way, 11 of them phase 3. Arthritis, Juvenile · Italy.
Among the 56 studies in Arthritis, Juvenile with a site in Italy, this one is the 14th largest by planned enrollment of the 43 interventional ones that give a count, is one of 5 that started in 2025, is one of 2 in phase 4, reaches primary completion later than 9 of the 23 other live ones, and was the 45th registered.
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
Browse Arthritis, Juvenile studies →20 of the 56 studies in Arthritis, Juvenile with a site in Italy are open now. Recruiting first, the newest first:
Alfasigma S.p.A. · Sites in Italy, Belgium, Czechia and 6 more countries
Ages 8–18
Duke University · Sites in Italy, United States, Germany and 1 more country
Ages 2–21
Novartis Pharmaceuticals · Sites in Italy, United States, Canada and 5 more countries
Ages 1+
Bristol-Myers Squibb · Sites in Italy, United States, Brazil and 8 more countries
Ages 5–17
Meyer Children's Hospital IRCCS · Sites in Italy
Ages 6–18
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 69 Arthritis, Juvenile studies recruiting now, 13 (19%) set no upper age limit and 50 (72%) stop at 75 or younger; 65 take children under 18; 11 take healthy volunteers.
This study: 2 Years to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
56 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 6 · Phase 3 28 · Phase 4 2
First in 2000; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 166 is above the median of 52 across 230 interventional studies indexed under Arthritis, Juvenile.
Median enrollment 90 across the 43 interventional studies, 130 across the 13 observational. Of the 30 that completed or were terminated, 20 (67%) have results posted.
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42 of 56 have an industry lead sponsor. The 10 most frequent:
Istituto Giannina Gaslini is the lead sponsor of 54 studies on the registry; 36 are open to participants now.
Istituto Giannina Gaslini has 4 studies filed under Arthritis, Juvenile — fewer than ten, so there is no comparison to draw.
3 of the studies in Arthritis, Juvenile with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07554495Phase 3Alfasigma S.p.A.Safety, Tolerability, Pharmacokinetics, and Efficacy of Filgotinib for the Treatment of Polyarticular-course Juvenile Idiopathic Arthritis in Children and Adolescents | 2027-06 |
| NCT06618937Istituto Giannina GasliniToward Personalized Medicine to Guide Drug Withdrawal in Children with Juvenile Idiopathic Arthritis in Clinical Remission | 2027-01-01 |
| NCT07203001Novartis PharmaceuticalsA Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease | 2027-04-22 |
Add all 3 to your calendar (.ics) → With an account.
Among the 56 studies in Arthritis, Juvenile with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Biologic therapies made clinical remission an achievable goal for most juvenile idiopathic arthritis (JIA) patients. Nevertheless, antirheumatic drugs have side effects and are costly. Currently, no guidelines exist for withdrawing drugs in JIA patients with clinical inactive disease (CID). Relapses following the withdrawal of antirheumatic drugs are common. To establish an optimal timeline for treatment discontinuation is a major unmet need in pediatric rheumatology.
It is hypothesized that biomarkers-guided early withdrawal of antirheumatic drugs in patients achieving clinical, imaging and biological remission is safe and more effective compared to the standard practice of maintenance of stable treatment over 12 months.
The study is designed as a multicenter, prospective, randomized, open label superiority trial of two different treatment medication withdrawal strategies (early biomarkers-guided versus conventional unguided drugs withdrawal strategy). Musculoskeletal ultrasound (MSUS) and serum biomarkers, such as the S-100 protein family, allow a more accurate assessment of remission status than clinical evaluation alone. Subclinical synovitis detected by MSUS at the joint level and increased level of S100 proteins have been associated with an increased risk of loss of clinically inactive disease after drug discontinuation. The results of this study will provide a more rational approach to treatment withdrawal in inactive JIA patients. It is expected that a risk-adapted strategy would reduce both number of disease flares and cumulative drug exposure compared with standard-of-care practice. If validated, these biomarkers will help to personalize immunosuppressant withdrawal: a therapy paradigm shift while ensuring patient and economic benefits.
Patients with inactive disease, absence of sublinical synovitis at the joint level and normal S100A8/9 and hs-CRP leves will be randomly assigned to either an early biomarker-guided drug withdrawal protocol (interventional arm) or continuation of ongoing therapy at unchanged dose for an additional 6 months and then gradual tapering (control arm).
Patients will be evaluated at baseline, then every 3 months if still on treatment and every 6 months after drug withdrawal. At each timepoint the following procedures will be performed: joint assessment, Physician's Global Assessment of Overall Disease Activity, JAMAR, Uveitis assessment (in ANA positive patients), Hematology, chemistry, CRP, ESR, urine analysis according to drug specific schedule and Good Clinical Practice (GCP). Drug Adverse Events will be collected (MedDRA).
MSUS and serum biomarkers quantification (S100A8/9, hs-CRP) will be repeated every 3 months until month 18 in patients with subclinical synovitis and pathologic values of serum biomarkers who are randomized in the intervention arm.
Blood samples for research laboratory analysis (multi Omics, characterization of immune cell populations and quantification of cytokines concentration and EV-miRNAs expression) will be collected at baseline, at drugs withdrawal and in case of disease flare.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with inactive disease, absence of sublinical synovitis at the joint level and normal S100A8/9 and hs-CRP leves will be randomly assigned to either an early biomarker-guided drug withdrawal protocol (interventional arm) or continuation of ongoing therapy at unchanged dose for an additional 6 months and then gradual tapering (control arm). Patients will be evaluated at baseline, then every 3 months if still on treatment and every 6 months after drug withdrawal. At each timepoint the following procedures will be performed: joint assessment, Physician's Global Assessment of Overall Disease Activity, JAMAR, Uveitis assessment (in ANA positive patients), Hematology, chemistry, CRP, ESR, urine analysis according to drug specific schedule and Good Clinical Practice (GCP). Drug Adverse Events will be collected (MedDRA). MSUS and serum biomarkers quantification (S100A8/9, hs-CRP) will be repeated every 3 months until month 18 in patients with subclinical synovitis and pathologic values
Other: Treatment medication withdrawal strategy
The control arm will continue ongoing therapy at unchanged dose for an additional 6 months and then will gradually taper the therapy.
The study aims to compare early biomarkers-guided versus conventional unguided drugs withdrawal strategy.
Effectiveness of early biomarker-guided withdrawal of antirheumatic agents
At each timepoint the following procedures will be performed: joint assessment, Physician's Global Assessment of Overall Disease Activity, JAMAR, Uveitis assessment (in ANA positive patients), Hematology, chemistry, CRP, ESR, urine analysis according to drug specific schedule and Good Clinical Practice (GCP). Drug Adverse Events will be collected (MedDRA), to measure safety and efficacy of early biomarker-guided withdrawal of antirheumatic agents in JIA patients achieving 6 months clinical inactive disease (CID) who do not have subclinical inflammation when compared to the standard practice of maintenance of stable treatment intensity over 12 months.
Time frame: 12 months
Rate of flare
To compare rate and time to flare in the randomized arms. Disease flare is defined as any patient who will loose the status of inactive disease or has a clinical Juvenile Arthritis Disease Activity Score (cJADAS)10 \>1.5 or 2.5 for oligoarticular or polyarticular disease, respectively and prompt the caring physician to make a major therapeutic intervention that could include an intrarticular glucocorticoid injection, the start of systemic glucocorticoid therapy, the restart of cs/b/ts-DMARDs at the conventional regimen. Frequencies of flares will be analyzed in both study arms and will be compared by means of the Chi-square test or the Fisher's exact test whenever appropriate. Bionomial exact 95% confidence interval will be also computed and reported.
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Jan 2027, 24 months later.
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Istituto Giannina Gaslini