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NCT01532869 · ClinicalTrials.gov registry record · Phase 3
A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 87
- Enrollment target
NCT01532869 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 87 participants.
The verdict
NCT01532869, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
Study Summary
This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.
Interventions
- DRUG Placebo
- DRUG tocilizumab [RoActemra/Actemra]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01532869
The ClinicalTrials.gov registry entry for NCT01532869 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 87 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.
NCT01532869 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01532869 about?
NCT01532869 is a clinical study titled "A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis". This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously we...
What is the current status of trial NCT01532869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2012-03. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01532869?
The interventions under investigation include: Placebo (DRUG), tocilizumab [RoActemra/Actemra] (DRUG).
Who is sponsoring clinical trial NCT01532869?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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