An extension study to check how safe, beneficial and tolerable the drugcanakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).

• Conditions: Cryopyrin Associated Periodic Syndromes (CAPS); MedDRA version: 14.1Level: PTClassification code 10068850Term: Cryopyrin associated periodic syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-005154-57-ES
• Lead Sponsor: ovartis Farmacéutica S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-27
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1.Patients who completed the core CACZ885D2307 study (a patient is defined as having completed the core study if they completed the study up to and including the EOS visit with no major protocol deviations in the core).
2.Male and female patients that are = 1 year of age at the time of the roll-over visit.
3.Parent or legal guardian written informed consent must be obtained before any assessment in the extension CACZ885D2307E1 study is performed.

Are the trial subjects under 18? yes
Number of subjects for this age range: 16
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients for whom continued treatment in the CACZ885D2307E1
extension study is not considered appropriate by the treating physician.
2.Patients who discontinued from the core CACZ885D2307 study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified