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NCT00810199 · ClinicalTrials.gov registry record · Phase 3

A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

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

Completed
Registry status
Phase 3
Development phase
556
Enrollment target
20
Study locations

NCT00810199 is a Phase 3 study of Rheumatoid Arthritis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 556 participants, below the 4,688-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT00810199, a Phase 3 study of Rheumatoid Arthritis, has completed, sponsored by Hoffmann-La Roche.

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

Study Summary

This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.

Conditions Studied

Rheumatoid Arthritis

Interventions

  • DRUG placebo
  • DRUG methotrexate
  • DRUG tocilizumab [RoActemra/Actemra]

Study Locations (20)

Florida

  • - Aventura
  • - Naples
  • - Orange Park
  • - Plantation
  • - Sarasota
  • - South Miami
  • - Tamarac

California

  • - Santa Monica
  • - Upland
  • - Whittier

Ohio

  • - Mayfield
  • - Middleburg Heights

Texas

  • - Houston
  • - San Antonio

Minnesota

  • - Eagan

Nevada

  • - Las Vegas

Oklahoma

  • - Oklahoma City

Pennsylvania

  • - West Reading

Trial Details

FieldValue
Enrollment Target 556 participants
Start Date 2009-03
Est. Completion 2013-01
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00810199

The ClinicalTrials.gov registry entry for NCT00810199 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 556 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,688-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (88% 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 3 interventions - of which placebo is the first listed.

NCT00810199 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Ohio.

Frequently Asked Questions

What is clinical trial NCT00810199 about?

NCT00810199 is a clinical study titled "A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment". This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 ...

What is the current status of trial NCT00810199?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 556 participants. The study started on 2009-03. Estimated completion is 2013-01.

What conditions does trial NCT00810199 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis.

What interventions are being tested in trial NCT00810199?

The interventions under investigation include: placebo (DRUG), methotrexate (DRUG), tocilizumab [RoActemra/Actemra] (DRUG).

Who is sponsoring clinical trial NCT00810199?

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

Where is trial NCT00810199 being conducted?

This trial has 20 study locations across California, Florida, Minnesota, Nevada, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.