β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3) (β-RELIEVED)
|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 evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01470989|
Recruitment Status : Completed
First Posted : November 11, 2011
Results First Posted : July 9, 2021
Last Update Posted : July 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Gouty Arthritis Flares||Drug: ACZ885 Drug: Triamcinolone acetonide 40 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
canakinumab 150 mg s.c.
canakinumab 150 mg s.c., given on demand upon new flares
Other Name: Canakinumab
Drug: Triamcinolone acetonide 40 mg
Participants received 40 mg intramuscular (IM)
Other Name: Triamcinolone acetonide
- 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.
- 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.
- 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).
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
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|