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NCT01232569 · ClinicalTrials.gov registry record · Phase 3

A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Phase 3 study of Rheumatoid Arthritis, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
656
Enrollment target
20
Study locations

NCT01232569 is a Phase 3 study of Rheumatoid Arthritis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 656 participants, below the 4,687-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT01232569, a Phase 3 study of Rheumatoid Arthritis, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
656 participants
Enrollment target
20
Study locations

Study Summary

This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.

Conditions Studied

Rheumatoid Arthritis

Interventions

  • DRUG Placebo
  • DRUG Tocilizumab 162 mg

Study Locations (20)

Arizona

  • - Peoria
  • - Scottsdale
  • - Tucson
  • - Tucson

California

  • - Fullerton
  • - San Diego
  • - San Leandro
  • - West Hills

Florida

  • - Boca Raton
  • - Jupiter
  • - Ormond Beach
  • - Sarasota

Idaho

  • - Idaho Falls
  • - Meridan

Illinois

  • - Springfield
  • - Vernon Hills

Maryland

  • - Crofton
  • - Hagerstown

Connecticut

  • - Trumbull

Georgia

  • - Gainesville

Trial Details

FieldValue
Enrollment Target 656 participants
Start Date 2011-03
Est. Completion 2013-11
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01232569

The ClinicalTrials.gov registry entry for NCT01232569 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 656 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,687-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (86% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01232569 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Arizona, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01232569 about?

NCT01232569 is a clinical study titled "A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis". This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumat...

What is the current status of trial NCT01232569?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 656 participants. The study started on 2011-03. Estimated completion is 2013-11.

What conditions does trial NCT01232569 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis.

What interventions are being tested in trial NCT01232569?

The interventions under investigation include: Placebo (DRUG), Tocilizumab 162 mg (DRUG).

Who is sponsoring clinical trial NCT01232569?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01232569 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.