An Open-label Extension Study With Canakinumab on the Treatment and Prevention of Gout Flares up to 3 Years (B-Relieved)
This study is currently recruiting participants.
Verified May 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01470989
First received: August 16, 2011
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
The purpose of this third extension study is to provide additional long-term safety and tolerability data of canakinumab over an 18-month time period on patients who have completed the extension studies CACZ885H2356E2 and CACZ885H2357E2. Overall, the treatment and follow-up period from the initial baseline visit in the core studies, and all subsequent extensions will amount to a total of up to 3 years.The study will provide additional safety data of repeated treatment with on-demand use of canakinumab in patients with gouty arthritis. The study may further be used to optimize patients' Urate Lowering Therapy (ULT) as needed, and collect further safety data on the concomitant use of canakinumab with different ULT regimens.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Gouty Arthritis |
Biological: canakinumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 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:
Primary Outcome Measures:
- Safety and tolerability of canakinumab [ Time Frame: 18 months ] [ Designated as safety issue: No ]Safety and tolerability will be evaluated by summarizing adverse events (including infections and malignancies), vital signs and laboratory data in patients exposed to canakinumab
Secondary Outcome Measures:
- Long-term efficacy of canakinumab defined as frequency of new flares [ Time Frame: 18 months ] [ Designated as safety issue: No ]Flare rate will be calculated as the number of new gout flares over the period of observations in years
- Long-term efficacy of canakinumab defined as Patient's assessment of gout pain intensity (Likert scale) [ Time Frame: 18 months ] [ Designated as safety issue: No ]Patient's assessment of gout pain intensity (Likert scale) will be measured on a daily basis over 14 days after each new flare starting one day after re-dosing until control visit
- Long-term efficacy of canakinumab defined as global assessment of response to treatment (Likert scale) [ Time Frame: 18 months ] [ Designated as safety issue: No ]Global assessment of response to treatment (Likert scale) will be measured on a daily basis over 14 days after each new flare starting one day after re-dosing until control visit
- Long-term efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein) [ Time Frame: 18 months ] [ Designated as safety issue: No ]hsCRP will be measured at scheduled (every 6 months) and unscheduled visits (flare/control visits)
- Immunogenicity of canakinumab [ Time Frame: 18 months ] [ Designated as safety issue: No ]Immunogenicity will be assessed at scheduled (every 6 months) and unscheduled visits (flare visits)
- Safety in the concomitant use of canakinumab with different urate lowering therapy regimens [ Time Frame: 18 months ] [ Designated as safety issue: No ]Safety in the concomitant use with different ULT regimens will be evaluated by summarizing adverse events (including infections and malignancies), urate lowering concomitant medications, vital signs and laboratory data in patients initiating or modifying their urate lowering therapy while exposed canakinumab
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Canakinumab |
Biological: canakinumab
Canakinumab 150 mg
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Patients who have completed the second extension studies
- Patients who have already been treated with canakinumab in the core studies or subsequent extensions
Exclusion criteria:
- Continuation in this extension study is considered inappropriate by the treating physician
- Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470989
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Contacts
| Contact: Novartis Pharmaceuticals | 862-778-8300 |
Hide Study LocationsLocations
| United States, Alabama | |
| Novartis Investigative site | Not yet recruiting |
| Mobile, Alabama, United States, 36608 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, California | |
| Novartis Investigative site | Not yet recruiting |
| Burbank, California, United States, 91505 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Florida | |
| Novartis Investigative site | Recruiting |
| Clearwater, Florida, United States, 33756 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Georgia | |
| Novartis Investigative site | Not yet recruiting |
| Decatur, Georgia, United States, 30035 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Idaho | |
| Novartis Investigative site | Not yet recruiting |
| Boise, Idaho, United States, 83702 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Kansas | |
| Novartis Investigative site | Not yet recruiting |
| Overland Park, Kansas, United States, 66215 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Louisiana | |
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| Baton Rouge, Louisiana, United States, 70808 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Michigan | |
| Novartis Investigative site | Not yet recruiting |
| Clarkston, Michigan, United States, 48346 | |
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| United States, Mississippi | |
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| Jackson, Mississippi, United States, 39209 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Nebraska | |
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| Omaha, Nebraska, United States, 68114 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, North Carolina | |
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| Charlotte, North Carolina, United States, 28209 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Ohio | |
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| Dayton, Ohio, United States, 45417 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Oklahoma | |
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| Oklahoma City, Oklahoma, United States, 73109 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Pennsylvania | |
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| Duncansville, Pennsylvania, United States, 16635 | |
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| United States, South Carolina | |
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| Charleston, South Carolina, United States, 29407 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Tennessee | |
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| Bristol, Tennessee, United States, 37620 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Texas | |
| Novartis Investigative site | Not yet recruiting |
| Lake Jackson, Texas, United States, 77566 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| United States, Virginia | |
| Novartis Investigative site | Not yet recruiting |
| Danville, Virginia, United States, 24541 | |
| Contact: Novartis Pharmaceuticals 862-778-8300 | |
| Australia | |
| Novartis Investigative site | Not yet recruiting |
| Darlinghurst, Australia | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Canada | |
| Novartis Investigative site | Not yet recruiting |
| Quebec, Canada | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| St Johns, Canada | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Estonia | |
| Novartis Investigative site | Not yet recruiting |
| Parnu, Estonia | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| Tallinn, Estonia | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Germany | |
| Novartis Investigative site | Not yet recruiting |
| Augsburg, Germany | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| Loehne, Germany | |
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| Novartis Investigative site | Not yet recruiting |
| Magdeburg, Germany | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Latvia | |
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| Riga, Latvia | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| Valmiera, Latvia | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Lithuania | |
| Novartis Investigative site | Not yet recruiting |
| Kaunas, Lithuania | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| Kedainiai, Lithuania | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| Klaipeda, Lithuania | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| Siauliai, Lithuania | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| Vilnius, Lithuania | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Russian Federation | |
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| Ekaterinburg, Russian Federation | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| Moscow, Russian Federation | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| Petrozavodsk, Russian Federation | |
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| Novartis Investigative site | Not yet recruiting |
| St Petersburg, Russian Federation | |
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| Novartis Investigative site | Not yet recruiting |
| Tver, Russian Federation | |
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| Novartis Investigative site | Not yet recruiting |
| Yaroslavi, Russian Federation | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Ukraine | |
| Novartis Investigative site | Not yet recruiting |
| Lviv, Ukraine | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative site | Not yet recruiting |
| Uzhgorod, Ukraine | |
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| Novartis Investigative site | Not yet recruiting |
| Zaporizhzhya, Ukraine | |
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01470989 History of Changes |
| Other Study ID Numbers: | CACZ885H2357E3, 2011-003414-17 |
| Study First Received: | August 16, 2011 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Estonia: The State Agency of Medicine Germany: Ministry of Work, Health and Social Affairs in North Rhine-Westph Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Russia: Pharmacological Committee, Ministry of Health United States: Food and Drug Administration Ukraine: Ministry of Health |
Keywords provided by Novartis:
|
Gout inflammatory gout acute gout flares |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Gouty Joint Diseases Musculoskeletal Diseases Gout Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors |
Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013