A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis
An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis
1 other identifier
interventional
30
1 country
4
Brief Summary
This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis. Patients who successfully completed studies WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will be allowed DMARDs according to the treatment they received in the previous studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 104 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 rheumatoid-arthritis
Started Oct 2010
Shorter than P25 for phase_3 rheumatoid-arthritis
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 4, 2010
CompletedFirst Posted
Study publicly available on registry
October 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedDecember 2, 2015
December 1, 2015
7 months
October 4, 2010
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Safety (incidence of adverse events)
104 weeks
Safety (laboratory assessments e.g. hematology)
104 weeks
Secondary Outcomes (1)
Efficacy: Change in Disease Activity Score (DAS28)
104 weeks
Study Arms (1)
1
EXPERIMENTALInterventions
8 mg/kg intravenously every 4 weeks in combination with allowed DMARDs
Eligibility Criteria
You may qualify if:
- Adult patients, \>/=18 years of age
- Moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study
- Patients successfully completed studies WA17823 and WA18696 in South Africa
- Body weight \<150 kg
You may not qualify if:
- Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug in studies WA17823 and WA18696
- Previous treatment with any cell depleting therapies
- Treatment with intravenous gamma globulin, plasmapheresis or Prosorba(TM) column since the last administration of study drug in studies WA17823 and WA18696
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Cape Town, 7405, South Africa
Unknown Facility
Cape Town, 7500, South Africa
Unknown Facility
Cape Town, 8001, South Africa
Unknown Facility
Diepkloof, 1862, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2010
First Posted
October 5, 2010
Study Start
October 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
December 2, 2015
Record last verified: 2015-12