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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.

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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

FieldValue
Enrollment Target 87 participants
Start Date 2012-03
Est. Completion 2015-08
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.