Clinical trial NCT01362608: 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: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gouty Arthritis
Keywords: Gout
Inflammatory gout
acute gout
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
timeFrame: at 72 hours post-dose
measure: Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
timeFrame: 12 weeks
Secondary outcomes:
measure: The Number of Patients With at Least 1 New Gout Flare
timeFrame: 12 weeks
measure: Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
timeFrame: baseline through 12 weeks
measure: Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
timeFrame: baseline through week 12
measure: Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
timeFrame: 72 hours through week 12
measure: Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
timeFrame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
measure: Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
timeFrame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
measure: Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
timeFrame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
measure: Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
timeFrame: baseline through week 12
measure: Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
timeFrame: 12 weeks
measure: Time to Complete Resolution of Pain: Survival Analysis by Treatment
timeFrame: 12 weeks
measure: Time to First Rescue Medication Intake
timeFrame: 12 weeks
measure: Percent Patients Who Took Rescue Medication
timeFrame: 12 weeks
measure: Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
timeFrame: 12 weeks
measure: High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose
timeFrame: 72 hours post dose
Other outcomes:
Locations:
city: Ciudad Autonoma de Bs As
country: Argentina
facility: Novartis Investigative Site
city: Hefei
country: China
facility: Novartis Investigative Site
state: Anhui
city: Hefei
country: China
facility: Novartis Investigative Site
state: Anhui
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Xi'an
country: China
facility: Novartis Investigative Site
state: Shanxi
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Wuhan
country: China
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: