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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

Primary Purpose

Gouty Arthritis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Canakinumab, ACZ885
Triamcinolone acetonide
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gouty Arthritis focused on measuring Gout, Inflammatory gout, acute gout

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Canakinumab and placebo matching to triamcinolone acetonide

Triamcinolone acetonide 40 mg

Arm Description

ACZ885H

ACZ885H

Outcomes

Primary Outcome Measures

The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
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)
Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
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

Secondary Outcome Measures

The Number of Patients With at Least 1 New Gout Flare
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
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)
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
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).
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
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).
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
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).
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).
Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
Kaplan Meier estimate
Time to Complete Resolution of Pain: Survival Analysis by Treatment
Kaplan Meier estimate
Time to First Rescue Medication Intake
Percent Patients Who Took Rescue Medication
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.
High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose

Full Information

First Posted
May 24, 2011
Last Updated
June 7, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01362608
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Study Start Date
June 20, 2011 (Actual)
Primary Completion Date
May 19, 2015 (Actual)
Study Completion Date
May 19, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gouty Arthritis
Keywords
Gout, Inflammatory gout, acute gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canakinumab and placebo matching to triamcinolone acetonide
Arm Type
Experimental
Arm Description
ACZ885H
Arm Title
Triamcinolone acetonide 40 mg
Arm Type
Active Comparator
Arm Description
ACZ885H
Intervention Type
Drug
Intervention Name(s)
Canakinumab, ACZ885
Intervention Description
Canakinumab and placebo matching to triamcinolone acetonide
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide
Intervention Description
Triamcinolone acetonide 40 mg and placebo matching to canakinumab
Primary Outcome Measure Information:
Title
The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
Description
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)
Time Frame
at 72 hours post-dose
Title
Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The Number of Patients With at Least 1 New Gout Flare
Time Frame
12 weeks
Title
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
Description
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)
Time Frame
baseline through 12 weeks
Title
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
Description
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).
Time Frame
baseline through week 12
Title
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
Description
Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).
Time Frame
72 hours through week 12
Title
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Description
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).
Time Frame
baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Title
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
Description
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).
Time Frame
baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Title
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
Description
Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).
Time Frame
baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Title
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
Description
Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).
Time Frame
baseline through week 12
Title
Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
Description
Kaplan Meier estimate
Time Frame
12 weeks
Title
Time to Complete Resolution of Pain: Survival Analysis by Treatment
Description
Kaplan Meier estimate
Time Frame
12 weeks
Title
Time to First Rescue Medication Intake
Time Frame
12 weeks
Title
Percent Patients Who Took Rescue Medication
Time Frame
12 weeks
Title
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Description
Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.
Time Frame
12 weeks
Title
High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose
Time Frame
72 hours post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Ciudad Autonoma de Bs As
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Novartis Investigative Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Novartis Investigative Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Novartis Investigative Site
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Novartis Investigative Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Novartis Investigative Site
City
Katowice
ZIP/Postal Code
40-084
Country
Poland
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
60-773
Country
Poland
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
529889
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

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

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