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NCT01476956 · ClinicalTrials.gov registry record

Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

A clinical trial of Rheumatoid Arthritis, sponsored by Care Arthritis.

Completed
Registry status
571
Enrollment target
20
Study locations

NCT01476956 is a study of Rheumatoid Arthritis that has completed, run by Care Arthritis. The registered enrollment target is 571 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.

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The verdict

NCT01476956, a study of Rheumatoid Arthritis, has completed, sponsored by Care Arthritis.

COMPLETED
Registry status
571 participants
Enrollment target
20
Study locations

Study Summary

Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy. Disease activity will be monitored systematically every 3 months by the Disease Activity Score. Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy will be made according to specific recommendations for patients receiving these therapies. Biomarker samples will be collected every 3 months and prior to change in DMARD and/or anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken for biomarker studies and processed according to the international committee of Outcome Measures in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples. A urine sample (20 ml) will also be taken and processed as for serum. Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months). Patients will be followed for 2 years.

Conditions Studied

Rheumatoid Arthritis

Interventions

  • OTHER Observational study

Study Locations (20)

Other

  • Department of Rheumatology, Copenhagen University Hospital at Glostrup - Glostrup Municipality
  • Service de Rheumatologie-CHU Bordeaux Pellegrin - Bordeaux
  • Le Roux Liana, Centre d'Investigation Clinique - Brest
  • Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie - Lille
  • Departement de rheumatologie, Hopital Lapeyronie - Montpellier
  • Rheumatologie B, Hopital Cochin - Paris
  • Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan - Toulouse
  • Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology - Bad Nauheim

New York

  • Rheumatologist Hospital for Special Surgery - New York
  • Division of Rheumatology, Columbia University, College of Physicians and Surgeons - New York
  • Division of Allergy, Immunology and Rheumatology, University of Rochester - Rochester

Alberta

  • University of Calgary - Calgary
  • Division of Rheumatology, University of Alberta Hospital - Edmonton

Maryland

  • Johns Hopkins Arthritis Center, Johns Hopkins University - Baltimore

Washington

  • Seattle Rheumatology Associates - Seattle

Manitoba

  • Arthritis Center, University of Manitoba - Winnipeg

Newfoundland and Labrador

  • Memorial University - St. John's

Ontario

  • The Arthritis Research Group - Newmarket

Trial Details

FieldValue
Enrollment Target 571 participants
Start Date 2011-10
Est. Completion 2019-12-31

Sponsor

Care Arthritis

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01476956

The ClinicalTrials.gov registry entry for NCT01476956 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 571 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,688-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (88% lower). The listed sponsor is Care Arthritis, which has 3 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 Observational study is the first listed.

NCT01476956 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, New York, Alberta.

Frequently Asked Questions

What is clinical trial NCT01476956 about?

NCT01476956 is a clinical study titled "Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography". Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy. Disease activity will be monitored systematically every 3 months by the Disease Activity Score. Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (...

What is the current status of trial NCT01476956?

This trial is currently completed. The enrollment target is 571 participants. The study started on 2011-10. Estimated completion is 2019-12-31.

What conditions does trial NCT01476956 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis.

What interventions are being tested in trial NCT01476956?

The interventions under investigation include: Observational study (OTHER).

Who is sponsoring clinical trial NCT01476956?

This trial is sponsored by Care Arthritis, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01476956 being conducted?

This trial has 20 study locations across Maryland, New York, Washington, Alberta, Manitoba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.