Juvenile Idiopathic Arthritis (JIA)NCT07211932
Tofacitinib in Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis (JIA), run by Consorci Sanitari de l'Alt Penedès i Garraf at 3 sites in Spain.
Trial summary
This study aims to evaluate, using real-world clinical practice data, the efficacy of tofacitinib in improving the clinical control of juvenile idiopathic arthritis (JIA) after 12 months of treatment. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA)
- What is being tested?
- Tofacitinib
- How many people
- 58 participants
- Where
- 3 sitesSpain
- Study dates
- Dec 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with JIA
Who may be able to join
- Diagnosis of juvenile idiopathic arthritis (JIA) documented in the medical record by the treating rheumatologist.
- Documentation in the medical record of the medical indication for tofacitinib treatment, with a diagnostic justification related to JIA.
- Age under 18 years at the time of the treatment indication with tofacitinib.
Who cannot join
- Participants diagnosed with any of the following conditions:
- Reactive arthritis
- Arthritis associated with inflammatory bowel disease
- Arthritis associated with another autoimmune disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites
Hospital Sant Joan de Déu Barcelona
Barcelona, Barcelona
Andrea Zacarías Crovato, +34 93 253 21 00, recerca@csapg.cat
Andrea Zacarías Crovato
Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Barcelona
Judith Sánchez Manubens, +34937231010, recerca@csapg.cat
Judith Sánchez Manubens
Hospital de Vilafranca
Vilafranca del Penedès, Barceona, 08720
Noemí Casaponsa, +34938960025 ext. 43197, recerca@csapg.cat
Vicenç Torrente, Ph.D.
About this study
Official title: Efficacy of Tofacitinib in Patients With Juvenile Idiopathic Arthritis: A Study Based on Real-world Clinical Practice Data.
This study aims to evaluate, using real-world clinical practice data, the efficacy of tofacitinib in improving the clinical control of juvenile idiopathic arthritis (JIA) after 12 months of treatment.
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Being tested
- Tofacitinib
- Keywords
- Arthritis, Juvenile, tofacitinib [Supplementary Concept], Janus Kinase Inhibitors
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
Patients received tofacitinib for the treatment of juvenile idiopathic arthritis (JIA).
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib | Patients affected by JIA and treated with tofacitinib Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
JADAS-10
Change in the Juvenile Arthritis Disease Activity Score (JADAS-10) score at 12 months of treatment with tofacitinib. Range score: 0 to 10, the less score the better
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211932
- Sponsor's protocol ID
- CSAPG-78
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tofacitinib in Patients With Juvenile Idiopathic Arthritis: A Study Based on Real-world Clinical Practice Data.
- ClinicalTrials.gov ID
- NCT07211932
- Acronym / sponsor ID
- CSAPG-78
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Keywords
- Arthritis, Juvenile, tofacitinib [Supplementary Concept], Janus Kinase Inhibitors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate, using real-world clinical practice data, the efficacy of tofacitinib in improving the clinical control of juvenile idiopathic arthritis (JIA) after 12 months of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib | – | Drug: TofacitinibPatients affected by JIA and treated with tofacitinib |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with JIA
Key inclusion criteria (3 listed)
- Diagnosis of juvenile idiopathic arthritis (JIA) documented in the medical record by the treating rheumatologist.
- Documentation in the medical record of the medical indication for tofacitinib treatment, with a diagnostic justification related to JIA.
- Age under 18 years at the time of the treatment indication with tofacitinib.
Key exclusion criteria (4 listed)
- Reactive arthritis
- Arthritis associated with inflammatory bowel disease
- Arthritis associated with another autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TofacitinibPatients received tofacitinib for the treatment of juvenile idiopathic arthritis (JIA). | Drug | Tofacitinib |
Primary outcome
JADAS-10
Time frame: Baseline and 12 months
Change in the Juvenile Arthritis Disease Activity Score (JADAS-10) score at 12 months of treatment with tofacitinib. Range score: 0 to 10, the less score the better
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis (JIA), run by Consorci Sanitari de l'Alt Penedès i Garraf at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noemí Casaponsa (+34938960025 ext. 43197, recerca@csapg.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
JADAS-10 (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.