Acute Gouty Arthritis Flares Clinical Trial
— ß-RELIEVEDOfficial 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
| Verified date | June 2021 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.
| Status | Completed |
| Enrollment | 136 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients who have completed the second extension studies CACZ885H2356E2 or CACZ885H2357E2 - Patients treated with canakinumab in the core studies or subsequent extensions Exclusion Criteria: - Pregnant or nursing (lactating) women |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Darlinghurst | New South Wales |
| Canada | Novartis Investigative Site | Sainte-Foy | Quebec |
| Canada | Novartis Investigative Site | St-John's | Newfoundland and Labrador |
| Canada | Novartis Investigative Site | St. John | Newfoundland and Labrador |
| Canada | Novartis Investigative Site | St. John's | Newfoundland and Labrador |
| Estonia | Novartis Investigative Site | Tallinn | |
| Estonia | Novartis Investigative Site | Tallinn | |
| Germany | Novartis Investigative Site | Augsburg | |
| Germany | Novartis Investigative Site | Loehne | |
| Germany | Novartis Investigative Site | Magdeburg | |
| Latvia | Novartis Investigative Site | Valmiera | |
| Lithuania | Novartis Investigative Site | Kaunas | |
| Lithuania | Novartis Investigative Site | Klaipeda | |
| Lithuania | Novartis Investigative Site | Siauliai | |
| Lithuania | Novartis Investigative Site | Vilnius | |
| Lithuania | Novartis Investigative Site | Vilnius | |
| Russian Federation | Novartis Investigative Site | Ekaterinburg | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Petrozavodsk | |
| Russian Federation | Novartis Investigative Site | St-Petersburg | |
| Russian Federation | Novartis Investigative Site | Yaroslavl | |
| Ukraine | Novartis Investigative Site | Uzhgorod | |
| Ukraine | Novartis Investigative Site | Zaporizhzhya | |
| United States | Novartis Investigative Site | Anniston | Alabama |
| United States | Novartis Investigative Site | Bristol | Tennessee |
| United States | Novartis Investigative Site | Charleston | South Carolina |
| United States | Novartis Investigative Site | Charleston | South Carolina |
| United States | Novartis Investigative Site | Clarksville | Tennessee |
| United States | Novartis Investigative Site | Clearwater | Florida |
| United States | Novartis Investigative Site | Columbia | South Carolina |
| United States | Novartis Investigative Site | Danville | Virginia |
| United States | Novartis Investigative Site | Dayton | Ohio |
| United States | Novartis Investigative Site | Decatur | Georgia |
| United States | Novartis Investigative Site | Flint | Michigan |
| United States | Novartis Investigative Site | Freehold | New Jersey |
| United States | Novartis Investigative Site | Hickory | North Carolina |
| United States | Novartis Investigative Site | Jackson | Mississippi |
| United States | Novartis Investigative Site | Jackson | Mississippi |
| United States | Novartis Investigative Site | Johnson City | Tennessee |
| United States | Novartis Investigative Site | Jupiter | Florida |
| United States | Novartis Investigative Site | Metairie | Louisiana |
| United States | Novartis Investigative Site | Missoula | Montana |
| United States | Novartis Investigative Site | Mobile | Alabama |
| United States | Novartis Investigative Site | Newport News | Virginia |
| United States | Novartis Investigative Site | Norwalk | California |
| United States | Novartis Investigative Site | Omaha | Nebraska |
| United States | Novartis Investigative Site | Opelousas | Louisiana |
| United States | Novartis Investigative Site | Overland Park | Kansas |
| United States | Novartis Investigative Site | Pasadena | California |
| United States | Novartis Investigative Site | San Diego | California |
| United States | Novartis Investigative Site | Topeka | Kansas |
| United States | Novartis Investigative Site | Troy | Michigan |
| United States | Novartis Investigative Site | Tustin | California |
| United States | Novartis Investigative Site | Varnville | South Carolina |
| United States | Novartis Investigative Site | Wichita | Kansas |
| United States | Novartis Investigative Site | Willoughby Hills | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Australia, Canada, Estonia, Germany, Latvia, Lithuania, Russian Federation, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants | Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline,or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. | From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks) | |
| Secondary | Number of New Flares Per Participant | Flare rate was calculated as the number of new flares over the period of observation in years. New flares occurred before first study medication dose in extension 3 study were considered. | From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks) | |
| Secondary | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint | Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild). | up to 7 days post-dose |