Long Term Study of Canakinumab (ACZ885) in Patients With Gout

NCT00927810 | Completed Phase 2 Results

• 1 other identifier: CACZ885H2251E1
• Study Type: interventional
• Target: 341
• Locations: 18 countries
• Sites: 45

Brief Summary

This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.

Conditions

Gouty Arthritis

Keywords

Gouty; Gouty arthritis; Gout flares; Anti-interleukin-1β monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events and Serious Adverse Events

  Adverse events (AEs) were defined as any unfavourable 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) hospitalisation, 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 study up to study completion (up to 14 months)

Secondary Outcomes (5)

• Difference Change From Baseline in Participant's Gout Pain During First Flare

  Baseline and Day 7

• Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category

  24 weeks

• Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category

  24 weeks

• Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group

  24 weeks

• Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group

  24 weeks

Study Arms (1)

canakinumab

EXPERIMENTAL

Drug: Canakinumab

Interventions

Canakinumab DRUG

canakinumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who completed the core study CACZ885H2251. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
• Patients who have signed a written informed consent before any trial procedure is performed.

You may not qualify if:

• Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
• Female patients who were physiologically capable of becoming pregnant, unless they were:
• Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner.
• Female patients whose partners had been sterilized by vasectomy or other means.
• Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) \< 1.
• Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (45)

Novartis Investigative site

Seattle, Washington, 98101, United States

Location

Novartis Investigative site

Capital Federal Buenos Aires, 1027, Argentina

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Jette, 1090, Belgium

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Barranquilla, Colombia

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Bogotá, Colombia

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Bucaramanga, Colombia

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Floridablanca, Colombia

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Prague, Czech Republic, 15006, Czechia

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Sachsen, Dresden / Schützenhöhe 16, D-01099, Germany

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Bayern, München / Mühlbaurstraße 16, D-81677, Germany

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Dessau, Roßlau / Kühnauer Straße 70 Sachsen- Anhalt, D-06846, Germany

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Guatemala City, 01015, Guatemala

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Debrecen, Bartók B U 2-26, 4043, Hungary

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Kistarcsa, Semmelweis Tér 1., 2143, Hungary

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Eger, Széchenyi U 27-29, 3301, Hungary

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Zalaegerszeg, Zrínyi U 1, 8900, Hungary

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Poznan, NA 61- 734, Poland

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Wroclaw, NA 50-333, Poland

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Lisbon, 1749-004, Portugal

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Chelyabinsk, 454047, Russia

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Moscow, 115522, Russia

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Moscow, 127473, Russia

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Petrozavodsk, Russia

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Saint Petersburg, 190068, Russia

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Saint Petersburg, 193015, Russia

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Yaroslavl, 150003, Russia

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Singapore, 169611, Singapore

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Bratislava, N/A 813 69, Slovakia

Location

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Košice, N/A 042 66, Slovakia

Location

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Nitra, N/A 949 01, Slovakia

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Piešťany, N/A 921 12, Slovakia

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Trenčín, N/A 911 50, Slovakia

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Pretoria, Gauteng, 0153, South Africa

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Madrid, 28046, Spain

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, 81346, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 11217, Taiwan

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Ankara, Bahcellievler, 06490, Turkey (Türkiye)

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Adana, Balcali, 01330, Turkey (Türkiye)

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Izmir, Inciraltı, 35340, Turkey (Türkiye)

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Aydin, Merkez, 09100, Turkey (Türkiye)

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Manisa, Merkez, 45010, Turkey (Türkiye)

Location

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Gaziantep, Sehitkamil, 27310, Turkey (Türkiye)

Location

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Jarrow, Tyne & Wear, NE32 3DT, United Kingdom

Location

Related Publications (1)

• Schlesinger N, Mysler E, Lin HY, De Meulemeester M, Rovensky J, Arulmani U, Balfour A, Krammer G, Sallstig P, So A. Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study. Ann Rheum Dis. 2011 Jul;70(7):1264-71. doi: 10.1136/ard.2010.144063. Epub 2011 May 3.

  PMID: 21540198 RESULT

MeSH Terms

Conditions

Arthritis, Gouty

Interventions

canakinumab

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 25, 2009
• Study Start: June 5, 2009
• Primary Completion: August 4, 2010
• Study Completion: August 4, 2010
• Last Updated: July 2, 2021
• Results First Posted: June 9, 2021

Record last verified: 2021-06

Locations

US (1); TU (6); BE (1); PT (1); RU (7); SL (5); PL (2); HU (4); ES (1); SG (1); TW (4); GU (1); DE (3); CO (4); ZA (1); GB (1); AR (1); CZ (1)