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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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01362608
First Posted: May 30, 2011
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention Phase
Gouty Arthritis Drug: Canakinumab, ACZ885 Drug: Triamcinolone acetonide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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)

  • 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


Secondary Outcome Measures:
  • The Number of Patients With at Least 1 New Gout Flare [ Time Frame: 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)

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment [ Time Frame: 12 weeks ]
    Kaplan Meier estimate

  • Time to Complete Resolution of Pain: Survival Analysis by Treatment [ Time Frame: 12 weeks ]
    Kaplan Meier estimate

  • Time to First Rescue Medication Intake [ Time Frame: 12 weeks ]
  • Percent Patients Who Took Rescue Medication [ Time Frame: 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.

  • High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose [ Time Frame: 72 hours post dose ]

Enrollment: 136
Actual Study Start Date: June 20, 2011
Study Completion Date: May 19, 2015
Primary Completion Date: May 19, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362608


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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01362608     History of Changes
Other Study ID Numbers: CACZ885H2358
2010-024172-26
First Submitted: May 24, 2011
First Posted: May 30, 2011
Results First Submitted: May 19, 2016
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Gout
Inflammatory gout
acute gout

Additional relevant MeSH terms:
Arthritis, Gouty
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Antibodies, Monoclonal
Triamcinolone diacetate
Colchicine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents