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β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3) (β-RELIEVED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01470989
First received: August 16, 2011
Last updated: November 14, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Acute Gouty Arthritis Flares
Drug: ACZ885
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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 [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    long-term safety and tolerability of canakinumab


Secondary Outcome Measures:
  • long-term efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    long-term efficacy of canakinumab defined as frequency of new flares


Other Outcome Measures:
  • long-term efficacy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    long-term efficacy of canakinumab, defined as patient's assessment of gout pain intensity (Likert scale) over time


Enrollment: 135
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: canakinumab
canakinumab 150 mg s.c.
Drug: ACZ885
canakinumab 150 mg s.c., given on demand upon new flares

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470989

  Hide Study Locations
Locations
United States, Alabama
Novartis Investigative Site
Anniston, Alabama, United States, 36207-5710
Novartis Investigative Site
Mobile, Alabama, United States, 36608
United States, California
Novartis Investigative Site
Norwalk, California, United States, 90650
Novartis Investigative Site
Pasadena, California, United States, 91105
Novartis Investigative Site
San Diego, California, United States, 92108
Novartis Investigative Site
Tustin, California, United States, 92780
United States, Florida
Novartis Investigative Site
Clearwater, Florida, United States, 33756
Novartis Investigative Site
Jupiter, Florida, United States, 33458
United States, Georgia
Novartis Investigative Site
Decatur, Georgia, United States, 30035
United States, Kansas
Novartis Investigative Site
Overland Park, Kansas, United States, 66215
Novartis Investigative Site
Topeka, Kansas, United States, 66606
Novartis Investigative Site
Wichita, Kansas, United States, 67208
United States, Louisiana
Novartis Investigative Site
Metairie, Louisiana, United States, 70006
Novartis Investigative Site
Opelousas, Louisiana, United States, 70570
United States, Michigan
Novartis Investigative Site
Flint, Michigan, United States, 48532
Novartis Investigative Site
Troy, Michigan, United States, 48085
United States, Mississippi
Novartis Investigative Site
Jackson, Mississippi, United States, 39202
Novartis Investigative Site
Jackson, Mississippi, United States, 39209
United States, Montana
Novartis Investigative Site
Missoula, Montana, United States, 59804
United States, Nebraska
Novartis Investigative Site
Omaha, Nebraska, United States, 68114
United States, New Jersey
Novartis Investigative Site
Freehold, New Jersey, United States, 07728
United States, North Carolina
Novartis Investigative Site
Hickory, North Carolina, United States, 28602
United States, Ohio
Novartis Investigative Site
Dayton, Ohio, United States, 45402
Novartis Investigative Site
Willoughby Hills, Ohio, United States, 44094
United States, South Carolina
Novartis Investigative Site
Charleston, South Carolina, United States, 29407
Novartis Investigative Site
Charleston, South Carolina, United States, 29412
Novartis Investigative Site
Columbia, South Carolina, United States, 29204
Novartis Investigative Site
Varnville, South Carolina, United States, 29944
United States, Tennessee
Novartis Investigative Site
Bristol, Tennessee, United States, 37620
Novartis Investigative Site
Clarksville, Tennessee, United States, 37043
Novartis Investigative Site
Johnson City, Tennessee, United States, 37601
United States, Virginia
Novartis Investigative Site
Danville, Virginia, United States, 24541
Novartis Investigative Site
Newport News, Virginia, United States, 23606
Australia, New South Wales
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Canada, Newfoundland and Labrador
Novartis Investigative Site
St-John's, Newfoundland and Labrador, Canada, A1E 2C2
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada, A1C 5B8
Novartis Investigative Site
St. John, Newfoundland and Labrador, Canada, A1B 5E8
Canada, Quebec
Novartis Investigative Site
Sainte-Foy, Quebec, Canada, G1V 3M7
Estonia
Novartis Investigative Site
Tallinn, Estonia, 10138
Novartis Investigative Site
Tallinn, Estonia, 13419
Germany
Novartis Investigative Site
Augsburg, Germany, 86159
Novartis Investigative Site
Loehne, Germany, 32584
Novartis Investigative Site
Magdeburg, Germany, 39110
Latvia
Novartis Investigative Site
Valmiera, Latvia, LV-4201
Lithuania
Novartis Investigative Site
Kaunas, Lithuania, 50009
Novartis Investigative Site
Klaipeda, Lithuania, 92288
Novartis Investigative Site
Siauliai, Lithuania, LT-76231
Novartis Investigative Site
Vilnius, Lithuania, 09020
Novartis Investigative Site
Vilnius, Lithuania, LT-08661
Russian Federation
Novartis Investigative Site
Ekaterinburg, Russian Federation, 620219
Novartis Investigative Site
Moscow, Russian Federation, 115522
Novartis Investigative Site
Petrozavodsk, Russian Federation, 185019
Novartis Investigative Site
St-Petersburg, Russian Federation, 190068
Novartis Investigative Site
Yaroslavl, Russian Federation, 150003
Ukraine
Novartis Investigative Site
Uzhgorod, Ukraine, 88009
Novartis Investigative Site
Zaporizhzhya, Ukraine, 69035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: 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: November 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
gouty arthritis

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

ClinicalTrials.gov processed this record on December 09, 2016