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

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Novartis
Study ID
NCT00554606
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 11, 2007
Status verified
Jun 2021
Primary completion
Aug 13, 2009
Completion
Aug 13, 2009

Study Design

Enrollment
115 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: From start of the study up to End Of Study (Week 60) ]

Locations (20)

FacilityCityStateZIPSite coordinators
Novartis Investigator SiteHuntsvilleAlabama35801-
Novartis Investigator SiteTuscaloosaAlabama35406-
Novartis Investigator SiteParadise ValleyArizona85253-
Novartis Investigator SiteTrumbullConnecticut06611-
Novartis Investigator SiteJacksonvilleFlorida32216-
Novartis Investigator SiteSouth MiamiFlorida33143-
Novartis Investigator SiteTamaracFlorida33321-
Novartis Investigator SiteRockfordIllinois61107-
Novartis Investigator SiteUrbandaleIndiana50322-
Novartis Investigator SiteRichmond HeightsMissouri63117-
Novartis Investigator SiteOmahaNebraska68114-
Novartis Investigator SiteRenoNevada89502-
Novartis Investigator SiteTulsaOklahoma74104-
Novartis Investigator SiteAustinTexas78704-
Novartis Investigator SiteCarrolltonTexas75007-
Novartis Investigator SiteDallasTexas75246-
Novartis Investigator SiteFort WorthTexas75246-
Novartis Investigator SiteMesquiteTexas75150-
Novartis Investigator SiteArlingtonVirginia22205-
Novartis Investigator SiteSpokaneWashington99204-

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