Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

This study is currently recruiting participants.

Verified April 2012 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT01362608

First received: May 24, 2011

Last updated: April 27, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2011

Last Updated Date

April 27, 2012

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The change in the gout pain intensity in the target joint following ACZ885 administration measured by Visual Analog Scale (VAS) The time to first new gout flare [ Time Frame: at 72 hours post-dose, 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01362608 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the time to 50% reduction of baseline pain intensity (measured on a 0-100 mm Visual Analog Scale) in the most affected joint affected by gout flare [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Evaluate the percentage of patients with at least 1 new gout flare [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Evaluate the efficacy of canakinumab compared with respect to the treatment of signs and symptoms of each acute gout flare [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the rescue medication use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein [hsCRP]) measured in the serum [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

Official Title ^ICMJE

A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) 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

Brief Summary

The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Gouty Arthritis

Intervention ^ICMJE

Biological: Canakinumab, ACZ885
Canakinumab and placebo matching to triamcinolone acetonide
Drug: Triamcinolone acetonide
Triamcinolone acetonide 40 mg and placebo matching to canakinumab

Study Arm (s)

Experimental: Canakinumab and placebo matching to triamcinolone acetonide
Intervention: Biological: Canakinumab, ACZ885
Active Comparator: Triamcinolone acetonide 40 mg
Intervention: Drug: Triamcinolone acetonide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

274

Completion Date

Not Provided

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Meeting diagnosis criteria for acute arthritis of primary gout.
Start of acute gout flare within 5 days prior to study visit 1
History of ≥ 3 gout flares within the 12 months prior to study start
Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines

Exclusion criteria:

Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide
Refractory heart failure (Stage D).
Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout
Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals

41-61-324-1111

Location Countries ^ICMJE

Argentina, China, Poland, Singapore

Administrative Information

NCT Number ^ICMJE

NCT01362608

Other Study ID Numbers ^ICMJE

CACZ885H2358, 2010-024172-26

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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