Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01593527
First received: May 3, 2012
Last updated: August 14, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).


Condition Intervention Phase
Acute Gouty Arthritis
Drug: ACZ885
Drug: Triamcinelone acetonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time to the first new gout flare [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of patients needing rescue medication use during acute gouty arthritis flare(s) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Measurement of efficacy using inflammatory markers [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Time to 50% reduction of baseline pain intensity in the most affected joint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Canakinumab 150 mg s.c.
Drug: ACZ885
Canakinumab 150 mg s.c.
Experimental: Arm 2
Triamcinelone acetonide 40 mg i.m.
Drug: Triamcinelone acetonide
Triamcinelone acetonide 40 mg i.m.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
  • Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
  • Onset of current acute gouty arthritis flare within 3 days prior to randomization

Exclusion criteria:

  • Hemodialysis CKD Stage 5 Organ transplantation
  • Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
  • Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01593527     History of Changes
Other Study ID Numbers: CACZ885H2402, 2011-001766-18
Study First Received: May 3, 2012
Last Updated: August 14, 2013
Health Authority: Brazil: National Committee of Ethics in Research
Canada: Canadian Institutes of Health Research
Colombia: Institutional Review Board
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: Scientific and Medical Research Council Ethics Committee
Iceland: Icelandic Medicines Control Agency
Israel: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Peru: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan : Food and Drug Administration
Ukraine: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Novartis:
Frequent flares
Frequent attacks
gout
gouty arthritis
Chronic kidney disease
renal impairment
Anti-interleukin-1β monoclonal antibody
anti-inflammatory therapy

Additional relevant MeSH terms:
Arthritis
Arthritis, Gouty
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Joint Diseases
Musculoskeletal Diseases
Gout
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Urologic Diseases
Renal Insufficiency
Triamcinolone Acetonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014