Clinical trial · Observational
Kineret CAPS Post Authorisation Study
Non-interventional PASS to Evaluate Safety of Kineret in Treatment of CAPS in Routine Clinical Care With Regard to Serious Infections, Malignancies, Injection Site Reactions, Allergic Reactions, Medication Errors Including Re-use of Syringe
- 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)
A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe.
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 |
|---|---|---|---|
| Cryopyrin-Associated Periodic Syndromes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anakinra (Kineret) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CAPS patients
- description
- CAPS patients treated with anakinra, using the Kineret graduated syringe
- interventionNames
- Drug: anakinra (Kineret)
Primary outcomes (5)
- measure
- Rate of serious infections
- timeFrame
- 3 years
- measure
- Rate of new malignancies
- timeFrame
- 3 years
- measure
- Rate of injection site reactions
- timeFrame
- 3 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Informed consent by the patient and/or caregiver * Kineret treatment will be according to the Summary of Product Characteristics (SmPC), as confirmed by the Investigator Exclusion Criteria: * None
References
Publications (0)
Data not yet available