Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
This study is not yet open for participant recruitment.
Verified May 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01593527
First received: May 3, 2012
Last updated: May 4, 2012
Last verified: May 2012
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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 ]
| Estimated Enrollment: | 230 |
| 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: | May 4, 2012 |
| 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 May 23, 2013