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NCT01163747 · ClinicalTrials.gov registry record · Phase 4
A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)
A Phase 4 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 4
- Development phase
- 91
- Enrollment target
NCT01163747: Completed Phase 4 study, sponsored by Genentech.
NCT01163747 is a Phase 4 study that has completed, run by Genentech. The registered enrollment target is 91 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01163747, a Phase 4 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 91 participants
- Enrollment target
Study Summary
This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.
Primary Outcome
Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of \> 1 mg/L from Baseline levels. The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C.
Interventions
- DRUG methotrexate
- BIOLOGICAL tocilizumab
- BIOLOGICAL 23-Valent Pneumococcal Polysaccharide Vaccine
- BIOLOGICAL Tetanus Toxoid Adsorbed Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-06 |
| Phase | Phase 4 |
What the finished NCT01163747 record still lists
NCT01163747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 4 interventions - of which methotrexate is the first listed.
NCT01163747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01163747 about?
NCT01163747 is a clinical study titled "A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)". This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or...
What is the current status of trial NCT01163747?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 91 participants. The study started on 2010-09. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01163747?
The interventions under investigation include: methotrexate (DRUG), tocilizumab (BIOLOGICAL), 23-Valent Pneumococcal Polysaccharide Vaccine (BIOLOGICAL), Tetanus Toxoid Adsorbed Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01163747?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01163747's enrollment target sits among peer trials
91 884th of 2000 higher than 1,115 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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