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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)

Primary Purpose

Acute Gouty Arthritis Flares

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ACZ885
Triamcinolone acetonide 40 mg
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gouty Arthritis Flares focused on measuring gouty arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Novartis Investigative Site
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  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

canakinumab

Arm Description

canakinumab 150 mg s.c.

Outcomes

Primary Outcome Measures

Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
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.

Secondary Outcome Measures

Number of New Flares Per Participant
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.
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild).

Full Information

First Posted
August 16, 2011
Last Updated
June 17, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01470989
Brief Title
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
Acronym
β-RELIEVED
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 Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gouty Arthritis Flares
Keywords
gouty arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
canakinumab
Arm Type
Experimental
Arm Description
canakinumab 150 mg s.c.
Intervention Type
Drug
Intervention Name(s)
ACZ885
Other Intervention Name(s)
Canakinumab
Intervention Description
canakinumab 150 mg s.c., given on demand upon new flares
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide 40 mg
Other Intervention Name(s)
Triamcinolone acetonide
Intervention Description
Participants received 40 mg intramuscular (IM)
Primary Outcome Measure Information:
Title
Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
Description
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.
Time Frame
From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Secondary Outcome Measure Information:
Title
Number of New Flares Per Participant
Description
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.
Time Frame
From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Title
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
Description
Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild).
Time Frame
up to 7 days post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207-5710
Country
United States
Facility Name
Novartis Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Novartis Investigative Site
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Novartis Investigative Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Novartis Investigative Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Novartis Investigative Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Novartis Investigative Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Novartis Investigative Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30035
Country
United States
Facility Name
Novartis Investigative Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Novartis Investigative Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novartis Investigative Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Novartis Investigative Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Novartis Investigative Site
City
Opelousas
State/Province
Louisiana
ZIP/Postal Code
70570
Country
United States
Facility Name
Novartis Investigative Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Novartis Investigative Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Novartis Investigative Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Novartis Investigative Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39209
Country
United States
Facility Name
Novartis Investigative Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Novartis Investigative Site
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Novartis Investigative Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Novartis Investigative Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45402
Country
United States
Facility Name
Novartis Investigative Site
City
Willoughby Hills
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Novartis Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Novartis Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Novartis Investigative Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Novartis Investigative Site
City
Varnville
State/Province
South Carolina
ZIP/Postal Code
29944
Country
United States
Facility Name
Novartis Investigative Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Novartis Investigative Site
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Novartis Investigative Site
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Novartis Investigative Site
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Novartis Investigative Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novartis Investigative Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Novartis Investigative Site
City
St-John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 2C2
Country
Canada
Facility Name
Novartis Investigative Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
Facility Name
Novartis Investigative Site
City
St. John
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 5E8
Country
Canada
Facility Name
Novartis Investigative Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Novartis Investigative Site
City
Augsburg
ZIP/Postal Code
86159
Country
Germany
Facility Name
Novartis Investigative Site
City
Loehne
ZIP/Postal Code
32584
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39110
Country
Germany
Facility Name
Novartis Investigative Site
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
Novartis Investigative Site
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Siauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Vilnius
ZIP/Postal Code
09020
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Ekaterinburg
ZIP/Postal Code
620219
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St-Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Uzhgorod
ZIP/Postal Code
88009
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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