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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: Completed Phase 3 study of Rheumatoid Arthritis, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remi
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 556 participants |
| Start Date | 2009-03 |
| Est. Completion | 2013-01 |
| Phase | Phase 3 |
What the finished NCT00810199 record still lists
NCT00810199 is an interventional study that assigns participants to a tested intervention. The registered 556 participants enrollment target is mid-sized for trials with a published cap, below the 4,688-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (88% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Rheumatoid Arthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00810199's enrollment target sits among peer trials
556 39th of 197 higher than 159 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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