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

June 17, 2021 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Novartis Investigative Site
  • Canada
    • Newfoundland and Labrador
      • St-John's, Newfoundland and Labrador, Canada, A1E 2C2
        • Novartis Investigative Site
      • St. John, Newfoundland and Labrador, Canada, A1B 5E8
        • Novartis Investigative Site
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • Novartis Investigative Site
    • Quebec
      • Sainte-Foy, Quebec, Canada, G1v 3M7
        • Novartis Investigative Site
  • Estonia
      • Tallinn, Estonia, 13419
        • Novartis Investigative Site
      • Tallinn, Estonia, 10138
        • Novartis Investigative Site
  • Germany
      • Augsburg, Germany, 86159
        • Novartis Investigative Site
      • Loehne, Germany, 32584
        • Novartis Investigative Site
      • Magdeburg, Germany, 39110
        • Novartis Investigative Site
  • Latvia
      • Valmiera, Latvia, LV-4201
        • Novartis Investigative Site
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Novartis Investigative Site
      • Klaipeda, Lithuania, 92288
        • Novartis Investigative Site
      • Siauliai, Lithuania, LT-76231
        • Novartis Investigative Site
      • Vilnius, Lithuania, LT-08661
        • Novartis Investigative Site
      • Vilnius, Lithuania, 09020
        • Novartis Investigative Site
  • Russian Federation
      • 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
        • Novartis Investigative Site
  • Ukraine
      • Uzhgorod, Ukraine, 88009
        • Novartis Investigative Site
      • Zaporizhzhya, Ukraine, 69035
        • Novartis Investigative Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207-5710
        • Novartis Investigative Site
      • Mobile, Alabama, United States, 36608
        • Novartis Investigative Site
    • California
      • 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
        • Novartis Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Novartis Investigative Site
      • Jupiter, Florida, United States, 33458
        • Novartis Investigative Site
    • Georgia
      • Decatur, Georgia, United States, 30035
        • Novartis Investigative Site
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Novartis Investigative Site
      • Topeka, Kansas, United States, 66606
        • Novartis Investigative Site
      • Wichita, Kansas, United States, 67208
        • Novartis Investigative Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Novartis Investigative Site
      • Opelousas, Louisiana, United States, 70570
        • Novartis Investigative Site
    • Michigan
      • Flint, Michigan, United States, 48532
        • Novartis Investigative Site
      • Troy, Michigan, United States, 48085
        • Novartis Investigative Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Novartis Investigative Site
      • Jackson, Mississippi, United States, 39209
        • Novartis Investigative Site
    • Montana
      • Missoula, Montana, United States, 59804
        • Novartis Investigative Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Novartis Investigative Site
    • New Jersey
      • Freehold, New Jersey, United States, 07728
        • Novartis Investigative Site
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Novartis Investigative Site
    • Ohio
      • Dayton, Ohio, United States, 45402
        • Novartis Investigative Site
      • Willoughby Hills, Ohio, United States, 44094
        • Novartis Investigative Site
    • South Carolina
      • 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
        • Novartis Investigative Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Novartis Investigative Site
      • Clarksville, Tennessee, United States, 37043
        • Novartis Investigative Site
      • Johnson City, Tennessee, United States, 37601
        • Novartis Investigative Site
    • Virginia
      • Danville, Virginia, United States, 24541
        • Novartis Investigative Site
      • Newport News, Virginia, United States, 23606
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: canakinumab
canakinumab 150 mg s.c.
Drug: ACZ885
canakinumab 150 mg s.c., given on demand upon new flares
Other Names:
  • Canakinumab
Drug: Triamcinolone acetonide 40 mg
Participants received 40 mg intramuscular (IM)
Other Names:
  • Triamcinolone acetonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
Time Frame: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline,or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of New Flares Per Participant
Time Frame: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Flare rate was calculated as the number of new flares over the period of observation in years. New flares occurred before first study medication dose in extension 3 study were considered.
From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
Time Frame: up to 7 days post-dose
Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild).
up to 7 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

November 9, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Actual)

July 9, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CACZ885H2357E3
  • 2011-003414-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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