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
- Canakinumab — DRUGCanakinumab
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: CanakinumabParticipants 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Novartis Investigator Site | Huntsville | Alabama | 35801 | - |
| Novartis Investigator Site | Tuscaloosa | Alabama | 35406 | - |
| Novartis Investigator Site | Paradise Valley | Arizona | 85253 | - |
| Novartis Investigator Site | Trumbull | Connecticut | 06611 | - |
| Novartis Investigator Site | Jacksonville | Florida | 32216 | - |
| Novartis Investigator Site | South Miami | Florida | 33143 | - |
| Novartis Investigator Site | Tamarac | Florida | 33321 | - |
| Novartis Investigator Site | Rockford | Illinois | 61107 | - |
| Novartis Investigator Site | Urbandale | Indiana | 50322 | - |
| Novartis Investigator Site | Richmond Heights | Missouri | 63117 | - |
| Novartis Investigator Site | Omaha | Nebraska | 68114 | - |
| Novartis Investigator Site | Reno | Nevada | 89502 | - |
| Novartis Investigator Site | Tulsa | Oklahoma | 74104 | - |
| Novartis Investigator Site | Austin | Texas | 78704 | - |
| Novartis Investigator Site | Carrollton | Texas | 75007 | - |
| Novartis Investigator Site | Dallas | Texas | 75246 | - |
| Novartis Investigator Site | Fort Worth | Texas | 75246 | - |
| Novartis Investigator Site | Mesquite | Texas | 75150 | - |
| Novartis Investigator Site | Arlington | Virginia | 22205 | - |
| Novartis Investigator Site | Spokane | Washington | 99204 | - |
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