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NCT02326376 Clinical Trial

Kineret CAPS Post Authorisation Study

Cryopyrin-Associated Periodic Syndromes Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02326376
Other study ID # Sobi.Anakin-201
Secondary ID ENCEPP/SDPP/6366
Status Completed
Phase
First received
Last updated
Start date April 24, 2015
Est. completion date September 12, 2019

Study information
Verified date January 2020
Source Swedish Orphan Biovitrum
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date September 12, 2019
Est. primary completion date September 12, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Cryopyrin-Associated Periodic Syndromes

Intervention

Drug:
• anakinra (Kineret)

Locations
Country Name City State
Netherlands Swedish Orphan Biovitrum Investigational Site Groningen
United Kingdom Swedish Orphan Biovitrum Investigational Site London

Sponsors (2)
Lead Sponsor Collaborator
Swedish Orphan Biovitrum Pediatric Rheumatology International Trials Organization

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of serious infections 3 years
Primary Rate of new malignancies 3 years
Primary Rate of injection site reactions 3 years
Primary Rate of allergic reactions 3 years
Primary Rate of medication errors including re-use of syringe 3 years
See also
  Status Clinical Trial Phase
Completed NCT00991146 - Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase Phase 3
Completed NCT01302860 - Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease Phase 3
Recruiting NCT03923140 - A Clinical Study of Tranilast in the Treatment of Cryopyrin-Associated Periodic Syndrome (CAPS) Phase 2
Completed NCT00685373 - Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease Phase 3
Completed NCT01576367 - Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease Phase 3