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Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
NCT01476956 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 571 participants |
| Start Date | 2011-10 |
| Est. Completion | 2019-12-31 |
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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 571 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CARE ARTHRITIS, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01476956 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, New York, Alberta. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01476956?
The interventions under investigation include: Observational study (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01476956?
This trial is sponsored by CARE ARTHRITIS, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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