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

NCT01470989 | Completed Phase 3 Results DMC

• 2 other identifiers: CACZ885H2357E32011-003414-17
• Study Type: interventional
• Target: 136
• Locations: 9 countries
• Sites: 56

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.

Conditions

Acute Gouty Arthritis Flares

Keywords

gouty arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)

Secondary Outcomes (2)

• Number of New Flares Per Participant

  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

  up to 7 days post-dose

Study Arms (1)

canakinumab

EXPERIMENTAL

canakinumab 150 mg s.c.

Drug: ACZ885; Drug: Triamcinolone acetonide 40 mg

Interventions

ACZ885 DRUG

canakinumab 150 mg s.c., given on demand upon new flares

Also known as: Canakinumab

canakinumab

Triamcinolone acetonide 40 mg DRUG

Participants received 40 mg intramuscular (IM)

Also known as: Triamcinolone acetonide

canakinumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have completed the second extension studies CACZ885H2356E2 or CACZ885H2357E2
• Patients treated with canakinumab in the core studies or subsequent extensions

You may not qualify if:

• \- Pregnant or nursing (lactating) women

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (56)

Novartis Investigative Site

Anniston, Alabama, 36207-5710, United States

Location

Novartis Investigative Site

Mobile, Alabama, 36608, United States

Location

Novartis Investigative Site

Norwalk, California, 90650, United States

Location

Novartis Investigative Site

Pasadena, California, 91105, United States

Location

Novartis Investigative Site

San Diego, California, 92108, United States

Location

Novartis Investigative Site

Tustin, California, 92780, United States

Location

Novartis Investigative Site

Clearwater, Florida, 33756, United States

Location

Novartis Investigative Site

Jupiter, Florida, 33458, United States

Location

Novartis Investigative Site

Decatur, Georgia, 30035, United States

Location

Novartis Investigative Site

Overland Park, Kansas, 66215, United States

Location

Novartis Investigative Site

Topeka, Kansas, 66606, United States

Location

Novartis Investigative Site

Wichita, Kansas, 67208, United States

Location

Novartis Investigative Site

Metairie, Louisiana, 70006, United States

Location

Novartis Investigative Site

Opelousas, Louisiana, 70570, United States

Location

Novartis Investigative Site

Flint, Michigan, 48532, United States

Location

Novartis Investigative Site

Troy, Michigan, 48085, United States

Location

Novartis Investigative Site

Jackson, Mississippi, 39202, United States

Location

Novartis Investigative Site

Jackson, Mississippi, 39209, United States

Location

Novartis Investigative Site

Missoula, Montana, 59804, United States

Location

Novartis Investigative Site

Omaha, Nebraska, 68114, United States

Location

Novartis Investigative Site

Freehold, New Jersey, 07728, United States

Location

Novartis Investigative Site

Hickory, North Carolina, 28602, United States

Location

Novartis Investigative Site

Dayton, Ohio, 45402, United States

Location

Novartis Investigative Site

Willoughby Hills, Ohio, 44094, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29407, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29412, United States

Location

Novartis Investigative Site

Columbia, South Carolina, 29204, United States

Location

Novartis Investigative Site

Varnville, South Carolina, 29944, United States

Location

Novartis Investigative Site

Bristol, Tennessee, 37620, United States

Location

Novartis Investigative Site

Clarksville, Tennessee, 37043, United States

Location

Novartis Investigative Site

Johnson City, Tennessee, 37601, United States

Location

Novartis Investigative Site

Danville, Virginia, 24541, United States

Location

Novartis Investigative Site

Newport News, Virginia, 23606, United States

Location

Novartis Investigative Site

Darlinghurst, New South Wales, 2010, Australia

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1B 5E8, Canada

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

Location

Novartis Investigative Site

St. John's, Newfoundland and Labrador, A1E 2C2, Canada

Location

Novartis Investigative Site

Sainte-Foy, Quebec, G1V 3M7, Canada

Location

Novartis Investigative Site

Tallinn, 10138, Estonia

Location

Novartis Investigative Site

Tallinn, 13419, Estonia

Location

Novartis Investigative Site

Augsburg, 86159, Germany

Location

Novartis Investigative Site

Löhne, 32584, Germany

Location

Novartis Investigative Site

Magdeburg, 39110, Germany

Location

Novartis Investigative Site

Valmiera, LV-4201, Latvia

Location

Novartis Investigative Site

Kaunas, 50009, Lithuania

Location

Novartis Investigative Site

Klaipėda, 92288, Lithuania

Location

Novartis Investigative Site

Šiauliai, LT-76231, Lithuania

Location

Novartis Investigative Site

Vilnius, 09020, Lithuania

Location

Novartis Investigative Site

Vilnius, LT-08661, Lithuania

Location

Novartis Investigative Site

Moscow, 115522, Russia

Location

Novartis Investigative Site

Petrozavodsk, 185019, Russia

Location

Novartis Investigative Site

Saint Petersburg, 190068, Russia

Location

Novartis Investigative Site

Yaroslavl, 150003, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620219, Russia

Location

Novartis Investigative Site

Uzhhorod, 88009, Ukraine

Location

Novartis Investigative Site

Zaporizhzhya, 69035, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Gouty

Interventions

canakinumab; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: November 11, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 9, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-06

Locations

US (33); AU (1); DE (3); CA (4); LI (5); UA (2); ES (2); LA (1); RU (5)