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NCT01194414 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants 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
- 1,262
- Enrollment target
- 20
- Study locations
NCT01194414 is a Phase 3 study of Rheumatoid Arthritis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,262 participants, below the 4,684-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT01194414, a Phase 3 study of Rheumatoid Arthritis, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,262 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 1,262 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 1,262 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,684-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (73% 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 5 interventions - of which tocilizumab SC is the first listed.
NCT01194414 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Alabama.
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.
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).
Who is sponsoring clinical trial NCT01194414?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
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