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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

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

Condition(s) targeted: Gouty Arthritis

Intervention: Canakinumab, ACZ885 (Drug); Triamcinolone acetonide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

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

Overall contact:
Novartis Pharmaceuticals, Phone: +41613241111

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.

Clinical Details

Official title: 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

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

Primary outcome: 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

Secondary outcome:

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

Evaluate the percentage of patients with at least 1 new gout flare

Evaluate the efficacy of canakinumab compared with respect to the treatment of signs and symptoms of each acute gout flare

To evaluate the rescue medication use

To evaluate the efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein [hsCRP]) measured in the serum

Eligibility

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

Criteria:

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

Locations and Contacts

Novartis Pharmaceuticals, Phone: +41613241111

Novartis Investigative Site, Cordoba X5022CPU, Argentina; Withdrawn

Novartis Investigative Site, San Juan J5402DIL, Argentina; Withdrawn

Novartis Investigative Site, Tucuman T4000AXL, Argentina; Withdrawn

Novartis Investigative Site, Beijing 100029, China; Recruiting

Novartis Investigative Site, Beijing 100044, China; Recruiting

Novartis Investigative Site, Chengdu 610072, China; Recruiting

Novartis Investigative Site, Shanghai 200032, China; Withdrawn

Novartis Investigative Site, Shanghai 200127, China; Recruiting

Novartis Investigative Site, Shanghai 200433, China; Recruiting

Novartis Investigative Site, Katowice 40-084, Poland; Recruiting

Novartis Investigative Site, Katowice 40-635, Poland; Withdrawn

Novartis Investigative Site, Krakow 31-159, Poland; Withdrawn

Novartis Investigative Site, Kutno 99-300, Poland; Withdrawn

Novartis Investigative Site, Poznan 60-773, Poland; Recruiting

Novartis Investigative Site, Wroclaw 50-044, Poland; Withdrawn

Novartis Investigative Site, Wroclaw 50-349, Poland; Recruiting

Novartis Investigative Site, Singapore 119074, Singapore; Recruiting

Novartis Investigative Site, Singapore 529889, Singapore; Recruiting

Novartis Investigative Site, Hefei, Anhui 230001, China; Recruiting

Novartis Investigative Site, Hefei, Anhui 230022, China; Recruiting

Novartis Investigative Site, Beijing, Beijing 100730, China; Completed

Novartis Investigative Site, Caba, Buenos Aires C1013AAR, Argentina; Completed

Novartis Investigative Site, Caba, Buenos Aires C1400, Argentina; Not yet recruiting

Novartis Investigative Site, Guangzhou, Guangdong 510030, China; Recruiting

Novartis Investigative Site, Nanjing, Jiangsu 210029, China; Recruiting

Novartis Investigative Site, Xi'an, Shanxi 710032, China; Recruiting

Novartis Investigative Site, Chengdu, Sichuan 610041, China; Recruiting

Novartis Investigative Site, Hangzhou, Zhejiang 310009, China; Recruiting

Additional Information

Starting date: July 2011
Last updated: February 23, 2015

Page last updated: August 23, 2015

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