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This study has been withdrawn prior to enrollment.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
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, see Learn About Clinical Studies.

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
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 August 21, 2014