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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)

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: NCT01470989
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Arthritis Gout
Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: canakinumab
canakinumab 150 mg s.c.
Drug: ACZ885
canakinumab 150 mg s.c., given on demand upon new flares

Primary Outcome Measures :
  1. safety and tolerability [ Time Frame: 18 months ]
    long-term safety and tolerability of canakinumab

Secondary Outcome Measures :
  1. long-term efficacy [ Time Frame: 18 months ]
    long-term efficacy of canakinumab defined as frequency of new flares

Other Outcome Measures:
  1. long-term efficacy [ Time Frame: 18 months ]
    long-term efficacy of canakinumab, defined as patient's assessment of gout pain intensity (Likert scale) over time

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01470989

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01470989    
Other Study ID Numbers: CACZ885H2357E3
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
gouty arthritis
Additional relevant MeSH terms:
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Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases