Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis

NCT00554606 | Completed Phase 2 Results

• 1 other identifier: CACZ885A2211
• Study Type: interventional
• Target: 115
• Locations: 9 countries
• Sites: 51

Brief Summary

This study will assess the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Anti-interleukin-1 beta; ACZ885

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events and Serious Adverse Events

  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 study up to End Of Study (Week 60)

Secondary Outcomes (21)

• Percentage of Participants Who Achieved American College of Rheumatology Response 20 (ACR20)

  Baseline Up to End Of Study (up to week 60)

• Percentage of Participants Who Achieved American College of Rheumatology Response 50 (ACR50)

  Baseline Up to End Of Study (up to week 60)

• Percentage of Participants Who Achieved American College of Rheumatology Response 70 (ACR70)

  Baseline Up to End Of Study (up to week 60)

• Percentage of Participants Who Achieved American College of Rheumatology Response 90 (ACR90)

  Baseline Up to End Of Study (up to week 60)

• Percentage of Participants Achieving Clinical Remission Based on Disease Activity Score (DAS) 28 and Simplified Disease Activity Index (SDAI)

  Baseline Up to End Of Study (up to week 60)

Study Arms (1)

Canakinumab

EXPERIMENTAL

Participants received one single dose of 600 mg canakinumab via intravenous infusion on Day 1 and thereafter every 6 weeks until completion of the 54-week treatment period.

Drug: Canakinumab

Interventions

Canakinumab DRUG

Canakinumab

Also known as: ACZ885

Canakinumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (male and non-pregnant, non-lactating females) who completed the core CACZ885A2204, CACZ885A2206, or CACZ885A2207 study without serious or severe drug-related adverse effects may enter the extension study upon signing informed consent

You may not qualify if:

• Patients for whom continued treatment in the extension is not considered appropriate by the treating physician.
• Patients who were non-compliant or who demonstrated a major protocol violation in the core study.
• Patients who did not complete / discontinued from the core study.
• Patients with drug related serious adverse events or severe adverse events.

Sponsors & Collaborators

• Novartis: lead

Study Sites (51)

Novartis Investigator Site

Huntsville, Alabama, 35801, United States

Location

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Tuscaloosa, Alabama, 35406, United States

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Paradise Valley, Arizona, 85253, United States

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Trumbull, Connecticut, 06611, United States

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Jacksonville, Florida, 32216, United States

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South Miami, Florida, 33143, United States

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Tamarac, Florida, 33321, United States

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Rockford, Illinois, 61107, United States

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Urbandale, Indiana, 50322, United States

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Richmond Heights, Missouri, 63117, United States

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Omaha, Nebraska, 68114, United States

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Reno, Nevada, 89502, United States

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Tulsa, Oklahoma, 74104, United States

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Austin, Texas, 78704, United States

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Carrollton, Texas, 75007, United States

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Dallas, Texas, 75246, United States

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Fort Worth, Texas, 75246, United States

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Mesquite, Texas, 75150, United States

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Arlington, Virginia, 22205, United States

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Spokane, Washington, 99204, United States

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Antwerp, Belgium

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Diepenbeek, Belgium

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Liège, Belgium

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Berlin, Germany

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Hamburg, Germany

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Hanover, Germany

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Ratingen, Germany

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Sendenhorst, Germany

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Wiesbaden, Germany

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Arenzano, GE, Italy

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Valeggio sul Mincio, VR, Italy

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Genova, Italy

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Padua, Italy

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Leeuwarden, Netherlands

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Leiden, Netherlands

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Venlo, Netherlands

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Moscow, Russia

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Yaroslavl, Russia

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Yekaterinburg, Russia

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Alicante, Spain

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Barcelona, Spain

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Bilbao, Spain

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Madrid, Spain

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Santiago de Compostela, Spain

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Seville, Spain

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Valencia, Spain

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Basel, Switzerland

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Zurich, Switzerland

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Sihhiye/Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis

Novartis.email@novartis.com

+41613241111

Study Officials

• NOVARTIS

  Novartis investigator site

  PRINCIPAL INVESTIGATOR

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: November 5, 2007
• First Posted: November 7, 2007
• Study Start: October 11, 2007
• Primary Completion: August 13, 2009
• Study Completion: August 13, 2009
• Last Updated: July 9, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-06

Locations

TU (3); RU (3); BE (3); ES (7); IT (4); DE (6); NL (3); US (20); CH (2)