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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)

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ClinicalTrials.gov Identifier: NCT01470989
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : February 23, 2017
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
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 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


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 ClinicalTrials.gov identifier (NCT number): NCT01470989


  Show 56 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01470989     History of Changes
Other Study ID Numbers: CACZ885H2357E3
2011-003414-17
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:
Arthritis
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Gout
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases