View Clinical Trial (Medical Research Study)
A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic DMARDs - NCT00891020-53045(Clinical Trial 329660)
ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.
| City: |
|
Brookfield |
|
State:
|
|
WI |
| Zip Code: |
|
53045 |
| Conditions: |
|
Rheumatoid Arthritis |
| Purpose: |
|
This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy
of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had
inadequate response to or are unable to tolerate DMARDs. Patients will be randomized to
receive tocilizumab either 4mg/kg iv or 8mg/kg iv with concomitant non-biologic DMARDs, or
8mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6
infusions. The anticipated time on study treatment is 3-12 months, and the target sample
size is 500-1000 individuals.
|
| Study summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
- adult patients, >=18 years of age;
- moderate to severe active rheumatoid arthritis for >6 months;
- inadequate clinical response or unable to tolerate current or prior biologic or
non-biologic DMARD therapy;
- SJC >/=4 and TJC >/=4
- body weight </=150kg
- current permitted non-biologic DMARDs must be on stable dose for >/= 7 weeks prior to
baseline;
Exclusion Criteria:
- history of autoimmune disease or inflammatory joint disease other than rheumatoid
arthritis;
- functional class IV as defined by the ACR Classification of Functional Status in
rheumatoid arthritis;
- treatment with rituximab within 6 months before screening;
- intraarticular corticosteroids within 8 weeks or im/iv corticosteroids within 12
weeks prior to screening;
- known active current or history of recurrent infections, or any major episode of
infection requiring hospitalization or treatment with iv antibiotics within 4 weeks
of screening, or oral antibiotics within 2 weeks prior to screening. |
|
|
|
| Study is available at: |
|
Brookfield, WI 53045
United States
Primary Contact:
Please reference Study ID Number: ML22533
Email: genentechclinicaltrials@druginfo.com
Phone: 888-662-6728 (U.S. Only) |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 23, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|