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NCT01209689 · ClinicalTrials.gov registry record · Phase 3
A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 113
- Enrollment target
NCT01209689 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 113 participants.
The verdict
NCT01209689, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 113 participants
- Enrollment target
Study Summary
This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all patients. This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.
Interventions
- DRUG Placebo
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01209689
The ClinicalTrials.gov registry entry for NCT01209689 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01209689 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01209689 about?
NCT01209689 is a clinical study titled "A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy". This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive toc...
What is the current status of trial NCT01209689?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 113 participants. The study started on 2010-10. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01209689?
The interventions under investigation include: Placebo (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT01209689?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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