Clinical Outcomes and Safety: A Registry Study of Ilaris (Canakinumab) Patients

An Open-label, Long-term, Prospective, Observational Study to Monitor the Safety and Effectiveness of Ilaris in CAPS Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01213641

Acronym

B-Confident

Enrollment

288

Registered

2010-10-04

Start date

2009-11-30

Completion date

2015-12-31

Last updated

2016-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryopyrin-associated Periodic Syndromes (CAPS), Familial Cold Autoinflam Syn (FCAS), Muckle-wells Syn (MWS), Neonatal Onset Multisystem Inflam Disease (NOMID)

Keywords

Cryopyrin-associated periodic syndromes(CAPS), CIAS1 protein, NLRP3 protein, human cryopyrin protein, Familial Cold Autoinflammatory Syndrome(FCAS), Muckle-Wells Syndrome(MWS), Neonatal Onset Multisystem Inflammatory disease(NOMID), NALP3, canakinumab, Interleukin-1(IL-1)

Brief summary

The purpose of this observational study is to collect additional information regarding long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical practice.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients receiving Ilaris (canakinumab) at the time of enrollment as part of medical care

Exclusion criteria

* Local regulations in some locations may exclude patients who receive Ilaris for a non-approved indication * Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
To monitor and further explore the overall safey of canakinumab focusing in serious infections	At least 5 years

Secondary

Measure	Time frame
Growth and development patterns of children aged 4 to 18 years of age exposed to Ilaris	at least 5 years
Identify previously unrecognized serious adverse drug reactions in the treated population	at least 5 years
Usage and patterns of dosing of Ilaris in routine clinical practice	at least 5 years
Long-term impact of Ilaris on disease progression (including systemic AA amyloidosis as evidenced by renal function, neurologic and ophthalmologic symptoms, and sensorineural deafness)	At least 5 years
Incidence of malignancies	at least 5 years
Incidence of hypersensitivity reactions	at least 5 years
Incidence of serious infections	at least 5 years

Countries

Austria, Germany, Norway, Switzerland, United States

Outcome results