Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01470989




Registration number
NCT01470989
Ethics application status
Date submitted
16/08/2011
Date registered
11/11/2011
Date last updated
9/07/2021

Titles & IDs
Public title
ß-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
Scientific 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
Secondary ID [1] 0 0
2011-003414-17
Secondary ID [2] 0 0
CACZ885H2357E3
Universal Trial Number (UTN)
Trial acronym
ß-RELIEVED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Gouty Arthritis Flares 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ACZ885
Treatment: Drugs - Triamcinolone acetonide 40 mg

Experimental: canakinumab - canakinumab 150 mg s.c.


Treatment: Drugs: ACZ885
canakinumab 150 mg s.c., given on demand upon new flares

Treatment: Drugs: Triamcinolone acetonide 40 mg
Participants received 40 mg intramuscular (IM)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
Timepoint [1] 0 0
From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Secondary outcome [1] 0 0
Number of New Flares Per Participant
Timepoint [1] 0 0
From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Secondary outcome [2] 0 0
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
Timepoint [2] 0 0
up to 7 days post-dose

Eligibility
Key inclusion criteria
- Patients who have completed the second extension studies CACZ885H2356E2 or
CACZ885H2357E2

- Patients treated with canakinumab in the core studies or subsequent extensions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or nursing (lactating) women

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2013
Sample size
Target
Accrual to date
Final
136
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Canada
State/province [17] 0 0
Newfoundland and Labrador
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Estonia
State/province [19] 0 0
Tallinn
Country [20] 0 0
Germany
State/province [20] 0 0
Augsburg
Country [21] 0 0
Germany
State/province [21] 0 0
Loehne
Country [22] 0 0
Germany
State/province [22] 0 0
Magdeburg
Country [23] 0 0
Latvia
State/province [23] 0 0
Valmiera
Country [24] 0 0
Lithuania
State/province [24] 0 0
Kaunas
Country [25] 0 0
Lithuania
State/province [25] 0 0
Klaipeda
Country [26] 0 0
Lithuania
State/province [26] 0 0
Siauliai
Country [27] 0 0
Lithuania
State/province [27] 0 0
Vilnius
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Ekaterinburg
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moscow
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Petrozavodsk
Country [31] 0 0
Russian Federation
State/province [31] 0 0
St-Petersburg
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Yaroslavl
Country [33] 0 0
Ukraine
State/province [33] 0 0
Uzhgorod
Country [34] 0 0
Ukraine
State/province [34] 0 0
Zaporizhzhya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01470989
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01470989