Evaluating Efficacy of Canakinumab (ACZ885) in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 8, 2009

Last Updated Date

January 8, 2009

Start Date ^†

December 2008

Current Primary Outcome Measures ^†

To determine the target dose of canakinumab that leads to at least comparable efficacy as colchicine with respect to the mean number of gout flares occurring during 16 weeks after randomization. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

To evaluate the efficacy of a repeat dose regimen of canakinumab as compared to the single doses of canakinumab with regards to the mean number of gout flares up to 16 weeks after randomization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate the number of patients with gout flares with canakinumab as compared to colchicine up to 16 weeks after randomization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate the time to first gout flare with canakimunab as compared to colchicine up to 16 weeks after randomization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate Patient's global pain intensity on a 0-100 mm VAS and 5-point Likert scale during gout flares with canakinumab as compared to colchicine up to 16 weeks after randomization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of canakinumab as compared to colchicine with regards to the Physician's global assessment of response to therapy on a 5-point Likert scale up to 16 weeks after randomization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Evaluating Efficacy of Canakinumab (ACZ885) in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy

Official Title ^†

A 24-Week, Dose-Ranging, Multi-Center, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate Canakinumab (ACZ885) for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy

Brief Summary

A 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled study to evaluate canakinumab (ACZ885) for prophylaxis of signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Condition ^†

Gout

Intervention ^†

Drug: ACZ885
Drug: Colchicine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

440

Completion Date

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Signed written informed consent before any study procedure is performed.
History of at least 2 gout flares in the year prior to the Screening Visit (based on patient history), thus, candidates for initiating uric acid lowering therapy.
Confirmed diagnosis of gout meeting the ACR 1977 preliminary criteria for the classification of arthritis of primary gout.
BMI < or = to 40 kg/m2.
Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within < or = to 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.

Exclusion Criteria:

Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period
History of allergy or contraindication to colchicine or allopurinol
History of intolerance to allopurinol or to oral colchine in appropriate dose for prophylactic use
History of bone marrow suppression
Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Novartis Pharmaceuticals

862-778-8300

Location Countries ^†

United States, Belgium, Guatemala, Singapore

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00819585

Responsible Party

External Affairs, Novartis Pharmaceuticals

Secondary IDs ^††

EudraCT : 2008-005876-28

Study Sponsor ^†

Novartis Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.