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NCT00580229 · ClinicalTrials.gov registry record · Phase 2

A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.

A Phase 2 study of Rheumatoid Arthritis, sponsored by University of South Florida.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target
2
Study locations

NCT00580229 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by University of South Florida. The registered enrollment target is 50 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT00580229, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by University of South Florida.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target
2
Study locations

Study Summary

This study will be an open-label prospective analysis of oral prednisone (compared to IV methylprednisolone) as a pre-treatment for rituximab in patients with rheumatoid arthritis. The study will be useful as pilot data to establish that there are no different trends between the two treatment strategies at decreasing the frequency and severity of acute infusion reactions. It would also establish proof of principle that pre-treatment with oral prednisone is equally as efficacious as IV methylprednisolone. The primary endpoint will be to assess the safety and tolerability of rituximab (Rituxan) in RA. By showing that there are no differences in the frequency or severity of acute infusion reactions after rituximab when using pre-treatment with oral prednisone compared to I.V. methylprednisolone, we will establish proof of principle that oral prednisone is a viable alternative to I.V. methylprednisolone. Pre-treatment with oral prednisone would be a practical advantage for both the patient and the treating physician. The patient could self-administer this treatment at home thereby decreasing the time they would need to spend at the infusion center. Further, this dose of prednisone has fewer side effects than 100mg of methylprednisolone.

Conditions Studied

Rheumatoid Arthritis

Interventions

  • DRUG prednisone

Study Locations (2)

Florida

  • Arthritis Research of Florida, Inc. - Palm Harbor
  • University of South Florida - Tampa

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2007-12
Est. Completion 2011-12
Phase Phase 2

Sponsor

University of South Florida

252 total trials

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What the Registry Record Tells You About NCT00580229

The ClinicalTrials.gov registry entry for NCT00580229 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which prednisone is the first listed.

NCT00580229 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT00580229 about?

NCT00580229 is a clinical study titled "A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.". This study will be an open-label prospective analysis of oral prednisone (compared to IV methylprednisolone) as a pre-treatment for rituximab in patients with rheumatoid arthritis. The study will be useful as pilot data to establish that there are no different trends between the two treatment strate...

What is the current status of trial NCT00580229?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2007-12. Estimated completion is 2011-12.

What conditions does trial NCT00580229 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis.

What interventions are being tested in trial NCT00580229?

The interventions under investigation include: prednisone (DRUG).

Who is sponsoring clinical trial NCT00580229?

This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00580229 being conducted?

This trial has 2 study locations across Florida. 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 Editorial

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.