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

June 7, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Bs As, Argentina, C1015ABO
        • Novartis Investigative Site
  • China
      • Beijing, China, 100044
        • Novartis Investigative Site
      • Beijing, China, 100029
        • Novartis Investigative Site
      • Shanghai, China, 200127
        • Novartis Investigative Site
      • Shanghai, China, 200433
        • Novartis Investigative Site
      • Wuhan, China, 430022
        • Novartis Investigative Site
    • Anhui
      • Hefei, Anhui, China, 230001
        • Novartis Investigative Site
      • Hefei, Anhui, China, 230022
        • Novartis Investigative Site
    • Beijing
      • Beijing, Beijing, China, 100730
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Novartis Investigative Site
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Novartis Investigative Site
      • Chengdu, Sichuan, China, 610072
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Novartis Investigative Site
  • Poland
      • Katowice, Poland, 40-084
        • Novartis Investigative Site
      • Poznan, Poland, 60-773
        • Novartis Investigative Site
      • Wroclaw, Poland, 50-349
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 529889
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canakinumab and placebo matching to triamcinolone acetonide
ACZ885H
Drug: Canakinumab, ACZ885
Canakinumab and placebo matching to triamcinolone acetonide
Active Comparator: Triamcinolone acetonide 40 mg
ACZ885H
Drug: Triamcinolone acetonide
Triamcinolone acetonide 40 mg and placebo matching to canakinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
Time Frame: at 72 hours post-dose
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
at 72 hours post-dose
Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
Time Frame: 12 weeks
Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Patients With at Least 1 New Gout Flare
Time Frame: 12 weeks
12 weeks
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
Time Frame: baseline through 12 weeks
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
baseline through 12 weeks
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
Time Frame: baseline through week 12
Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme).
baseline through week 12
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
Time Frame: 72 hours through week 12
Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).
72 hours through week 12
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Time Frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
Time Frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
Time Frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).
baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
Time Frame: baseline through week 12
Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).
baseline through week 12
Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
Time Frame: 12 weeks
Kaplan Meier estimate
12 weeks
Time to Complete Resolution of Pain: Survival Analysis by Treatment
Time Frame: 12 weeks
Kaplan Meier estimate
12 weeks
Time to First Rescue Medication Intake
Time Frame: 12 weeks
12 weeks
Percent Patients Who Took Rescue Medication
Time Frame: 12 weeks
12 weeks
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Time Frame: 12 weeks
Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.
12 weeks
High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose
Time Frame: 72 hours post dose
72 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2011

Primary Completion (Actual)

May 19, 2015

Study Completion (Actual)

May 19, 2015

Study Registration Dates

First Submitted

May 24, 2011

First Submitted That Met QC Criteria

May 26, 2011

First Posted (Estimate)

May 30, 2011

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CACZ885H2358
  • 2010-024172-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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