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COMPLETED Phase 3

A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis

NCT01194414 · View on ClinicalTrials.gov ↗

Study Summary

This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.

Conditions Studied

Interventions

  • DRUG tocilizumab SC
  • DRUG tocilizumab IV
  • DRUG placebo to tocilizumab SC
  • DRUG placebo to tocilizumab IV
  • DRUG Disease-modifying antirheumatic drugs (DMARDs)

Study Locations (20)

Florida

  • — Delray Beach
  • — Miami
  • — Ocala
  • — Orlando
  • — Palm Harbor
  • — Pinellas Park
  • — South Miami
  • — Tampa

California

  • — Long Beach
  • — Los Angeles
  • — Upland
  • — Van Nuys

Alabama

  • — Huntsville
  • — Tuscaloosa

Arizona

  • — Tucson
  • — Tucson

Colorado

  • — Denver

Connecticut

  • — Bridgeport

Idaho

  • — Coeur d'Alene

Illinois

  • — Morton Grove

Trial Details

FieldValue
Enrollment Target 1,262 participants
Start Date 2010-09
Est. Completion 2013-08
Phase Phase 3

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01194414

The ClinicalTrials.gov registry entry for NCT01194414 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,262 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 5 interventions — of which tocilizumab SC is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01194414 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01194414 about?

NCT01194414 is a clinical study titled "A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis". This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc we...

What is the current status of trial NCT01194414?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,262 participants. The study started on 2010-09. Estimated completion is 2013-08.

What conditions does trial NCT01194414 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01194414?

The interventions under investigation include: tocilizumab SC (DRUG), tocilizumab IV (DRUG), placebo to tocilizumab SC (DRUG), placebo to tocilizumab IV (DRUG), Disease-modifying antirheumatic drugs (DMARDs) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01194414?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01194414 being conducted?

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

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial