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

NCT ID: NCT00554606

Last Updated: 2021-07-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-11

Study Completion Date

2009-08-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Canakinumab

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.

Group Type EXPERIMENTAL

Canakinumab

Intervention Type DRUG

Canakinumab

Interventions

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Canakinumab

Canakinumab

Intervention Type DRUG

Other Intervention Names

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ACZ885

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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NOVARTIS

Role: PRINCIPAL_INVESTIGATOR

Novartis investigator site

Locations

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Novartis Investigator Site

Huntsville, Alabama, United States

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Tuscaloosa, Alabama, United States

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Paradise Valley, Arizona, United States

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Trumbull, Connecticut, United States

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Jacksonville, Florida, United States

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South Miami, Florida, United States

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Tamarac, Florida, United States

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Rockford, Illinois, United States

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Urbandale, Indiana, United States

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Richmond Heights, Missouri, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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Tulsa, Oklahoma, United States

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Austin, Texas, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Mesquite, Texas, United States

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Arlington, Virginia, United States

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Spokane, Washington, 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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Novartis Investigator Site

Istanbul, , Turkey (Türkiye)

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Novartis Investigator Site

Izmir, , Turkey (Türkiye)

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Novartis Investigator Site

Sihhiye/Ankara, , Turkey (Türkiye)

Site Status

Countries

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United States Belgium Germany Italy Netherlands Russia Spain Switzerland Turkey (Türkiye)

Other Identifiers

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CACZ885A2211

Identifier Type: -

Identifier Source: org_study_id

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