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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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: August 16, 2011
Last updated: April 11, 2016
Last verified: April 2016
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01470989

  Show 56 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01470989     History of Changes
Other Study ID Numbers: CACZ885H2357E3  2011-003414-17 
Study First Received: August 16, 2011
Last Updated: April 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
gouty arthritis

Additional relevant MeSH terms:
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases processed this record on October 27, 2016