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Trial record 61 of 75 for:    "Collagen Disease" | "Triamcinolone"

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

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. Identifier: NCT01593527
Recruitment Status : Withdrawn
First Posted : May 8, 2012
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Gouty Arthritis Drug: ACZ885 Drug: Triamcinelone acetonide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2012
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
Drug Information available for: Canakinumab

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. The time to the first new gout flare [ Time Frame: 12 Weeks ]
  2. Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution [ Time Frame: 12 weeks ]
  3. Number of patients needing rescue medication use during acute gouty arthritis flare(s) [ Time Frame: 12 Weeks ]
  4. Measurement of efficacy using inflammatory markers [ Time Frame: 12 Weeks ]
  5. Time to 50% reduction of baseline pain intensity in the most affected joint [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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

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

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01593527     History of Changes
Other Study ID Numbers: CACZ885H2402
2011-001766-18 ( EudraCT Number )
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: August 2013

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

Additional relevant MeSH terms:
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Rheumatic Diseases
Triamcinolone Acetonide
Kidney Diseases
Renal Insufficiency, Chronic
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Urologic Diseases
Renal Insufficiency
Crystal Arthropathies
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Antibodies, Monoclonal
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors