MedTrace Logo

Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

NCT01476956 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 571

Last updated 2021-10-27

No results posted yet for this 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

Interventions

OTHER

Observational study

RA patients on standard DMARD therapy

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • CARE ARTHRITIS LTD.

    lead INDUSTRY

Principal Investigators

  • Walter P. Maksymowych, MD · CaRE Arthritis

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-12-31
Completion
2019-12-31

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Germany
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Norway

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01476956 on ClinicalTrials.gov