Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

  Show 56 Study Locations
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 06, 2016