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NCT01791153 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 251
- Enrollment target
NCT01791153: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01791153 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 251 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01791153, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 251 participants
- Enrollment target
Study Summary
This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-up period (Part 2). In Part 1 of the study eligible participants will be randomized to receive either tocilizumab every week (qw) or every 2 weeks (q2w) or placebo for 52 weeks, with tapering oral daily doses of prednisone. After Week 52, participants in remission will stop study treatment and enter long-term follow-up, whereas participants with disease activity or flares will receive open-label tocilizumab or other treatment at the discretion of the investigator for a maximum period of 104 weeks.
Primary Outcome
Remission was defined as the absence of flare and normalization of the C-reactive protein (CRP) (less than \[\<\] 1 milligram per deciliter \[mg/dL\]). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (\>/=) 30 millimeters pe
Interventions
- DRUG Prednisone
- DRUG Tocilizumab
- DRUG Corticosteroids
- DRUG Tocilizumab Placebo
- DRUG Prednisone Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2013-07-22 |
| Est. Completion | 2018-06-04 |
| Phase | Phase 3 |
What the finished NCT01791153 record still lists
NCT01791153 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 5 interventions - of which Prednisone is the first listed.
NCT01791153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01791153 about?
NCT01791153 is a clinical study titled "An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)". This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of tocilizumab in participants with GCA. The study will consist of 2 parts: a 52-week double-blind treatment period (Part 1) followed by a 104-week open label long-term follow-u...
What is the current status of trial NCT01791153?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 251 participants. The study started on 2013-07-22. Estimated completion is 2018-06-04.
What interventions are being tested in trial NCT01791153?
The interventions under investigation include: Prednisone (DRUG), Tocilizumab (DRUG), Corticosteroids (DRUG), Tocilizumab Placebo (DRUG), Prednisone Placebo (DRUG).
Who is sponsoring clinical trial NCT01791153?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01791153's enrollment target sits among peer trials
251 1249th of 2000 higher than 752 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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