Clinical trial · Interventional
Influence of Therapeutic Education in Patients With Joint Inflammation Treated With a Biological Treatment
Impact of a Therapeutic Education Program in Patients With Non-radiological Spondyloarthritis Treated With Anti-tumor Necrosis Factor (TNF)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To describe, with a patient reported score (BIOSECURE), the influence of an approved therapeutic education program (TEP) in patients with joint inflammation requiring a biological treatment initiation. The hypothesis is that patients attending the TEP will display better cognitive and adaptation competences than patients with no TEP. Patient's reported quality of life, disease related stress management, treatment adherence, socio-demographic factors, biological home administration modalities and if the biologic treatment is maintained at 12 months, will also be described.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-radiographic Spondyloarthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Education program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Therapeutic Education Program
- description
- Patient randomized in this arm will attend a 1 day long validated Therapeutic Education Program. This program will take place within 6 months after biologic treatment initiation.
- interventionNames
- Other: Education program
- type
- NO_INTERVENTION
- label
- No therapeutic Education Program
- description
- Patient randomized in this arm will not attend a Therapeutic Education Program within 12 months after biologic treatment initiation.
Primary outcomes (1)
- measure
- BIOSECURE patient self-questionnaire
- timeFrame
- Change from Baseline Biosecure's score at 6 months and at 12 month after biological treatment initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-radiological spondyloarthritis diagnosis (ASAS criteria) * Anti-TNFalpha biological treatment initiation required * Adult patient (age\>18years) * Capacity to understand self-questionnaires and address questions * Patient accepting to attend a therapeutic education program (TEP) Exclusion Criteria: * Previous Anti-TNFalpha biological treatment * Previous attendance to a TEP concerning biological or spondyloarthritis * Contraindication to Anti-TNFalpha treatment * Associated and unbalanced diseases
References
Publications (0)
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