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NCT00578565 · ClinicalTrials.gov registry record · Phase 3
Rituximab in Rheumatoid Arthritis Lung Disease
A Phase 3 study of Rheumatoid Arthritis and Interstitial Pneumonia, sponsored by Eric Matteson.
- Completed
- Registry status
- Phase 3
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT00578565: Completed Phase 3 study of Rheumatoid Arthritis and Interstitial Pneumonia, sponsored by Eric Matteson.
NCT00578565 is a Phase 3 study of Rheumatoid Arthritis and Interstitial Pneumonia that has completed, run by Eric Matteson. The registered enrollment target is 10 participants, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00578565, a Phase 3 study of Rheumatoid Arthritis and Interstitial Pneumonia, has completed, sponsored by Eric Matteson.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will examine the course of patients with progressive rheumatoid arthritis associated interstitial lung disease (RA-ILD) treated with rituximab for safety and progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be assessed through patient history, physical exams and laboratory parameters. * Twelve male/or female patient with RA-associated lung disease (6 of each nonspecific interstitial pneumonia (NSIP) and usual interstitial pneumonia (UIP) histological subtype) will be enrolled * The study involves 12 visits over 48 weeks * Rituximab will be administered intravenously at Day 1 and Day 15 with repeat dosing at six months.
Primary Outcome
DLco is one pulmonary function measure. For DLco, worsening was defined as decrease of at least 15% and improvement was defined as increase of at least 15%.
Conditions Studied
Interventions
- DRUG Rituximab
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2007-05 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
What the finished NCT00578565 record still lists
NCT00578565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Rituximab is the first listed.
NCT00578565 reports a single indexed study location in Massachusetts, Minnesota.
Frequently Asked Questions
What is clinical trial NCT00578565 about?
NCT00578565 is a clinical study titled "Rituximab in Rheumatoid Arthritis Lung Disease". This study will examine the course of patients with progressive rheumatoid arthritis associated interstitial lung disease (RA-ILD) treated with rituximab for safety and progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be assessed through patient history, physic...
What is the current status of trial NCT00578565?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10 participants. The study started on 2007-05. Estimated completion is 2011-06.
What conditions does trial NCT00578565 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Interstitial Pneumonia.
What interventions are being tested in trial NCT00578565?
The interventions under investigation include: Rituximab (DRUG).
Who is sponsoring clinical trial NCT00578565?
This trial is sponsored by Eric Matteson, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00578565 being conducted?
This trial has 2 study locations across Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00578565's enrollment target sits among peer trials
10 197th of 197 higher than 1 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
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