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NCT00487825 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis

A Phase 2 study of Rheumatoid Arthritis, sponsored by Novartis.

Completed
Registry status
Phase 2
Development phase
78
Enrollment target
20
Study locations

NCT00487825 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by Novartis. The registered enrollment target is 78 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT00487825, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 2
Development phase
78 participants
Enrollment target
20
Study locations

Study Summary

This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Methotrexate (MTX)
  • DRUG Canakinumab (investigational)

Study Locations (20)

Florida

  • Jacksonville Center for Clinical Research (Dr. Steven Mathews) - Jacksonville
  • Center for Arthritis and Rheumatic Diseases (Dr. Michael Weitz) - South Miami
  • West Broward Rheumatology Associates, Incorporated (Dr. Elias Halpert) - Tamarac

Texas

  • MetaClin Research, Incorporated (Dr. Paul Pickrell) - Austin
  • John M. Joseph, MD (Dr. John Joseph) - Carlton
  • Southwest Rheumatology, P.A. (Dr. Atul Singhal) - Mesquite

Other

  • Novartis Investigative site - Brussels
  • Novartis investigative site - Nuremberg
  • Novartis investigative site - Milan

Alabama

  • Rheumatology Associates of Northern Alabama (Dr. William Shergy) - Huntsville
  • Clinic for Rheumatic Diseases (Dr. Richard Jones, III) - Tuscaloosa

Arizona

  • Arizona Arthritis and Rheumatology Research (Dr. Paul Caldron) - Paradise Valley

Illinois

  • Rockford Orthopedic Associates (Dr. Richard Olson) - Rockford

Iowa

  • Mercy Arthritis and Osteoporosis Center (Dr. Alan Braun) - Urbandale

Missouri

  • Clayton Medical Research (Dr. Iri Don) - Richmond Heights

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2007-03
Est. Completion 2008-12
Phase Phase 2

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT00487825

The ClinicalTrials.gov registry entry for NCT00487825 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 78 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 (98% lower). The listed sponsor is Novartis, which has 265 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.

NCT00487825 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Texas, Other.

Frequently Asked Questions

What is clinical trial NCT00487825 about?

NCT00487825 is a clinical study titled "Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis". This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)

What is the current status of trial NCT00487825?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2007-03. Estimated completion is 2008-12.

What conditions does trial NCT00487825 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis.

What interventions are being tested in trial NCT00487825?

The interventions under investigation include: Placebo (DRUG), Methotrexate (MTX) (DRUG), Canakinumab (investigational) (DRUG).

Who is sponsoring clinical trial NCT00487825?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00487825 being conducted?

This trial has 20 study locations across Alabama, Arizona, Florida, Illinois, Iowa. 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.