NCT01213641

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Longer than P75 for all trials

Geographic Reach
5 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 28, 2016

Status Verified

March 1, 2016

Enrollment Period

6.1 years

First QC Date

September 30, 2010

Last Update Submit

March 25, 2016

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 proteinNLRP3 proteinhuman cryopyrin proteinFamilial Cold Autoinflammatory Syndrome(FCAS)Muckle-Wells Syndrome(MWS)Neonatal Onset Multisystem Inflammatory disease(NOMID)NALP3canakinumabInterleukin-1(IL-1)

Outcome Measures

Primary Outcomes (1)

  • To monitor and further explore the overall safey of canakinumab focusing in serious infections

    At least 5 years

Secondary Outcomes (7)

  • 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

  • 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

  • Incidence of serious infections

    at least 5 years

  • +2 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with CAPS and treated with canakinumab. Patients treated with canakinumab for other autoinflammatory diseases may be included where allowed per local regulations.

You may qualify if:

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

You may not qualify if:

  • Local regulations in some locations may exclude patients who receive Ilaris for a non-approved indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Little Rock Allergy and Asthma Clinic

Little Rock, Arizona, 72205, United States

Location

Allergy Center at Brookstone

Columbus, Georgia, 31904, United States

Location

Rush Presbyterian - St. Lukes Medical Center

Chicago, Illinois, 60612, United States

Location

Novartis Investigative site

Bregenz, Austria

Location

Novartis Investigative site

Vienna, Austria

Location

Novartis Investigative site

Dresden, Germany

Location

Novartis Investigative site

Hamburg, Germany

Location

Novartis Investigative site

Heidelberg, Germany

Location

Novartis Investigative site

Herne, Germany

Location

Novartis Investigative site

Kiel, Germany

Location

Novartis Investigative site

Schweinfurt, Germany

Location

Novartis Investigative site

Tübingen, Germany

Location

Novartis Investigative site

Oslo, Norway

Location

Novartis Investigative site

Aarau, Switzerland

Location

Novartis Investigative site

Basel, Switzerland

Location

Novartis Investigative site

Geneva, Switzerland

Location

Novartis Investigative site

Lausanne, Switzerland

Location

Related Publications (1)

  • Walker UA, Tilson HH, Hawkins PN, Poll TV, Noviello S, Levy J, Vritzali E, Hoffman HM, Kuemmerle-Deschner JB; CACZ885D2401 Study Investigators. Long-term safety and effectiveness of canakinumab therapy in patients with cryopyrin-associated periodic syndrome: results from the beta-Confident Registry. RMD Open. 2021 May;7(2):e001663. doi: 10.1136/rmdopen-2021-001663.

    PMID: 34001647DERIVED

MeSH Terms

Conditions

Cryopyrin-Associated Periodic Syndromes

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesChronic Inducible UrticariaChronic UrticariaUrticariaSkin Diseases, VascularCold UrticariaHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 4, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 28, 2016

Record last verified: 2016-03

Locations

AU(2)US(3)DE(7)CH(4)NO(1)