Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Observational study

• Registration Number: NCT01476956
• Lead Sponsor: CARE ARTHRITIS LTD.

Brief 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.

Detailed Description

Treatment is Disease Activity Score (DAS) driven. Changes in standard DMARD and/or anti-TNFα therapy will be implemented according to 2010 European League against Rheumatism (EULAR) recommendations which state a target of remission (DAS44 \<1.6) for patients receiving standard DMARD therapy in the setting of early disease and a target of low disease activity state (LDAS) (DAS44 ≤2.4) for patients receiving anti-TNFα therapy in the setting of established disease.

Study Timeline

• Study First Submitted: 2011-06-01
• Study Start: 2011-10
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Primary Completion: 2017-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 571

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid Arthritis	Observational study	-

Primary Outcome Measures

Name	Time	Method
To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA).	24 Months

Secondary Outcome Measures

Name	Time	Method
To establish which modifiable clinical and laboratory predictors used in routine practice individually and in combination, have the strongest and the most consistent association with change in radiographic damage in patients on standard RA therapy.	24 Months

Trial Locations

Locations (36)

Division of Rheumatology, Columbia University, College of Physicians and Surgeons; 🇺🇸 New York, New York, United States

Johns Hopkins Arthritis Center, Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Seattle Rheumatology Associates; 🇺🇸 Seattle, Washington, United States

Le Roux Liana, Centre d'Investigation Clinique; 🇫🇷 Brest, France

Department of Rheumatology, St. Vincents University Hospital; 🇮🇪 Dublin, Ireland

Day Hospital Reumatologia; 🇮🇹 Milano, Italy

Division of Allergy, Immunology and Rheumatology, University of Rochester; 🇺🇸 Rochester, New York, United States

Universitatsklinikum der Friedrich-Schiller-Universitat Jena, Klinik für Innere Medizin III/Rheumatologie/Osteologie; 🇩🇪 Jena, Germany

Dr Spieler; 🇩🇪 Zerbst, Germany

University of Milan; 🇮🇹 Milan, Italy

Department of Rheumatology, University of Verona; 🇮🇹 Verona, Italy

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Saskatoon Osteoporosis Centre; 🇨🇦 Saskatoon, Saskatchewan, Canada

Rheumatologie B, Hopital Cochin; 🇫🇷 Paris, France

Departement de rheumatologie, Hopital Lapeyronie; 🇫🇷 Montpellier, France

Division of Rheumatology, University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

University of Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Rheumatologist Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Department of Rheumatology, Copenhagen University Hospital at Glostrup; 🇩🇰 Glostrup, Denmark

University of Ferrara; 🇮🇹 Ferrara, Italy

University of Padova; 🇮🇹 Padova, Italy

Memorial University; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Arthritis Center, University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Service de Rheumatologie-CHU Bordeaux Pellegrin; 🇫🇷 Bordeaux, France

Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie; 🇫🇷 Lille, France

Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology; 🇩🇪 Bad Nauheim, Germany

Tel Aviv Sourasky Medical Centre; 🇮🇱 Tel Aviv, Israel

Amsterdam VU University Medical Centre; 🇳🇱 Amsterdam, Netherlands

Academic Medical Centre/University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Academic Medical Centre/University of Amsterdam and Atrium Medical Centre Heerlen; 🇳🇱 Heerlen, Netherlands

Afdeling Reumatologie, Leids Universitair Medisch Centrum; 🇳🇱 Leiden, Netherlands

Department of Rheumatology, Diakonhjemmet Hospital; 🇳🇴 Oslo, Norway

The Arthritis Research Group; 🇨🇦 Newmarket, Ontario, Canada

Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan; 🇫🇷 Toulouse, France

Department of Rheumatology/Clinical Immunology, Medizinische Klinik-Rheumatologie und Klinische Immunologie; 🇩🇪 Berlin, Germany

Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy