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An Open-label Extension Study With Canakinumab on the Treatment and Prevention of Gout Flares up to 3 Years

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Gouty Arthritis

Intervention: canakinumab (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

The purpose of this third extension study is to provide additional long-term safety and tolerability data of canakinumab over an 18-month time period on patients who have completed the extension studies CACZ885H2356E2 and CACZ885H2357E2. Overall, the treatment and follow-up period from the initial baseline visit in the core studies, and all subsequent extensions will amount to a total of up to 3 years. The study will provide additional safety data of repeated treatment with on-demand use of canakinumab in patients with gouty arthritis. The study may further be used to optimize patients' Urate Lowering Therapy (ULT) as needed, and collect further safety data on the concomitant use of canakinumab with different ULT regimens.

Clinical Details

Official title: An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety and tolerability of canakinumab

Secondary outcome:

Long-term efficacy of canakinumab defined as frequency of new flares

Long-term efficacy of canakinumab defined as Patient's assessment of gout pain intensity (Likert scale)

Long-term efficacy of canakinumab defined as global assessment of response to treatment (Likert scale)

Long-term efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein)

Immunogenicity of canakinumab

Safety in the concomitant use of canakinumab with different urate lowering therapy regimens

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Patients who have completed the second extension studies

- Patients who have already been treated with canakinumab in the core studies or

subsequent extensions Exclusion criteria:

- Continuation in this extension study is considered inappropriate by the treating

physician

- Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigative site, Darlinghurst, Australia

Novartis Investigative site, Quebec, Canada

Novartis Investigative site, St Johns, Canada

Novartis Investigative site, Parnu, Estonia

Novartis Investigative site, Tallinn, Estonia

Novartis Investigative site, Augsburg, Germany

Novartis Investigative site, Loehne, Germany

Novartis Investigative site, Magdeburg, Germany

Novartis Investigative site, Riga, Latvia

Novartis Investigative site, Valmiera, Latvia

Novartis Investigative site, Kaunas, Lithuania

Novartis Investigative site, Kedainiai, Lithuania

Novartis Investigative site, Klaipeda, Lithuania

Novartis Investigative site, Siauliai, Lithuania

Novartis Investigative site, Vilnius, Lithuania

Novartis Investigative site, Ekaterinburg, Russian Federation

Novartis Investigative site, Moscow, Russian Federation

Novartis Investigative site, Petrozavodsk, Russian Federation

Novartis Investigative site, St Petersburg, Russian Federation

Novartis Investigative site, Tver, Russian Federation

Novartis Investigative site, Yaroslavi, Russian Federation

Novartis Investigative site, Lviv, Ukraine

Novartis Investigative site, Uzhgorod, Ukraine

Novartis Investigative site, Zaporizhzhya, Ukraine

Novartis Investigative site, Mobile, Alabama 36608, United States

Novartis Investigative site, Burbank, California 91505, United States

Novartis Investigative site, Clearwater, Florida 33756, United States

Novartis Investigative site, Decatur, Georgia 30035, United States

Novartis Investigative site, Boise, Idaho 83702, United States

Novartis Investigative site, Overland Park, Kansas 66215, United States

Novartis Investigative site, Baton Rouge, Louisiana 70808, United States

Novartis Investigative site, Clarkston, Michigan 48346, United States

Novartis Investigative site, Jackson, Mississippi 39209, United States

Novartis Investigative site, Omaha, Nebraska 68114, United States

Novartis Investigative site, Charlotte, North Carolina 28209, United States

Novartis Investigative site, Dayton, Ohio 45417, United States

Novartis Investigative site, Oklahoma City, Oklahoma 73109, United States

Novartis Investigative site, Duncansville, Pennsylvania 16635, United States

Novartis Investigative site, Charleston, South Carolina 29407, United States

Novartis Investigative site, Bristol, Tennessee 37620, United States

Novartis Investigative site, Lake Jackson, Texas 77566, United States

Novartis Investigative site, Danville, Virginia 24541, United States

Additional Information

Starting date: November 2011
Last updated: May 15, 2014

Page last updated: August 23, 2015

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