Tofacitinib in Juvenile Idiopathic Arthritis

NCT07211932 | Not Yet Recruiting

• 1 other identifier: CSAPG-78
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Juvenile Idiopathic Arthritis (JIA)

Keywords

Arthritis, Juvenile; tofacitinib [Supplementary Concept]; Janus Kinase Inhibitors

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and 12 months

Study Arms (1)

Tofacitinib

Patients affected by JIA and treated with tofacitinib

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

Patients received tofacitinib for the treatment of juvenile idiopathic arthritis (JIA).

Tofacitinib

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with JIA

You may qualify if:

• 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.

You may not qualify if:

• Participants diagnosed with any of the following conditions:
• Reactive arthritis
• Arthritis associated with inflammatory bowel disease
• Arthritis associated with another autoimmune disease

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (3)

Hospital Sant Joan de Déu Barcelona

Barcelona, Barcelona, Spain

Location

Corporació Sanitària Parc Taulí de Sabadell

Sabadell, Barcelona, Spain

Location

Hospital de Vilafranca

Vilafranca del Penedès, Barceona, 08720, Spain

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Noemí Casaponsa

CONTACT

+34938960025; recerca@csapg.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of main results of the study.
• Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.

Locations

ES (3)