Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

NCT01476956 | Completed

• 1 other identifier: RA BIODAM
• Study Type: observational
• Target: 571
• Locations: 10 countries
• Sites: 36

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA).

  24 Months

Secondary Outcomes (1)

• 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

Study Arms (1)

Rheumatoid Arthritis

Other: Observational study

Interventions

Observational study OTHER

RA patients on standard DMARD therapy

Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

RA patients from rheumatologists' clinics

You may qualify if:

• years of age or older
• RA according to the 2010 Rheumatoid Arthritis Classification Criteria
• Joint symptoms for ≥ 3 months prior to screening
• DAS44 \> 2.4
• About to start DMARD therapy (methotrexate, salazopyrin, hydroxychloroquine, chloroquine, leflunomide) or
• increased dose of methotrexate by ≥10 mg weekly to a maximum dose of 25mg weekly (if already receiving \>15mg will require add-on DMARD/anti-TNF or switch to alternative DMARD),
• add-on of alternative DMARD,
• switch to alternative DMARD,
• start of first anti-TNFα agent (adalimumab, etanercept, infliximab, certolizumab pegol, golimumab)
• If already on DMARD therapy this has been stable for the 3 months prior to the baseline visit
• If already on systemic steroid, dose must be stable (prednisone ≤ 7.5mg/day) for 1 month prior to the baseline visit
• Patient will be available for follow up for a minimum of 24 months from the baseline visit

You may not qualify if:

• Intra-articular steroid injection within 4 weeks prior to the baseline visit
• Prior treatment with anti-TNFα or other biological agent (rituximab, abatacept, tocilizumab)
• Malignancy within past 5 years (other than basal cell carcinoma that has been adequately treated or excised, squamous cell cancer of the skin, and cervical carcinoma in situ)
• History of:
• Serious infection (defined as requiring parenteral antibiotics or hospitalization) within 3 months prior to the baseline visit;
• Active tuberculosis or history of tuberculosis without documented curative treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative)
• For patients starting anti-TNF therapy, a positive TB screening test and no record of effective prophylaxis according to local expert recommendations
• Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C

Sponsors & Collaborators

• CARE ARTHRITIS LTD.: lead
• Abbott: collaborator

Study Sites (36)

Johns Hopkins Arthritis Center, Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Rheumatologist Hospital for Special Surgery

New York, New York, 10021, United States

Location

Division of Rheumatology, Columbia University, College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Division of Allergy, Immunology and Rheumatology, University of Rochester

Rochester, New York, 14642, United States

Location

Seattle Rheumatology Associates

Seattle, Washington, 98104, United States

Location

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

Division of Rheumatology, University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Arthritis Center, University of Manitoba

Winnipeg, Manitoba, R3A 1M4, Canada

Location

Memorial University

St. John's, Newfoundland and Labrador, A1C 5B3, Canada

Location

The Arthritis Research Group

Newmarket, Ontario, L3Y 3R7, Canada

Location

University of Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Saskatoon Osteoporosis Centre

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Department of Rheumatology, Copenhagen University Hospital at Glostrup

Glostrup Municipality, DK-2600, Denmark

Location

Service de Rheumatologie-CHU Bordeaux Pellegrin

Bordeaux, 33000, France

Location

Le Roux Liana, Centre d'Investigation Clinique

Brest, 29200, France

Location

Centre des Consultations et imagerie de l'appareil locomoteur service de rheumatologie

Lille, France

Location

Departement de rheumatologie, Hopital Lapeyronie

Montpellier, 34295, France

Location

Rheumatologie B, Hopital Cochin

Paris, 75014, France

Location

Infirmiere de Recherche Clinique, CHU de Toulouse, Centre de Rheumatologie, Hopital Purpan

Toulouse, 31059, France

Location

Kerckhoff-Klinik, Department of Rheumatology and Clinical Immunology

Bad Nauheim, D-61231, Germany

Location

Department of Rheumatology/Clinical Immunology, Medizinische Klinik-Rheumatologie und Klinische Immunologie

Berlin, Germany

Location

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

Jena, 07747, Germany

Location

Dr Spieler

Zerbst, 39261, Germany

Location

Department of Rheumatology, St. Vincents University Hospital

Dublin, Ireland

Location

Tel Aviv Sourasky Medical Centre

Tel Aviv, 64239, Israel

Location

University of Ferrara

Ferrara, 44121, Italy

Location

University of Milan

Milan, 20157, Italy

Location

Day Hospital Reumatologia

Milan, 20122, Italy

Location

University of Padova

Padua, 35128, Italy

Location

Catholic University of the Sacred Heart

Rome, 00168, Italy

Location

Department of Rheumatology, University of Verona

Verona, 37067, Italy

Location

Amsterdam VU University Medical Centre

Amsterdam, 0157 AB Amsterdam, Netherlands

Location

Academic Medical Centre/University of Amsterdam

Amsterdam, 1100 DE Amsterdam, Netherlands

Location

Academic Medical Centre/University of Amsterdam and Atrium Medical Centre Heerlen

Heerlen, 6419 PC Heerlen, Netherlands

Location

Afdeling Reumatologie, Leids Universitair Medisch Centrum

Leiden, 2300 RC Leiden, Netherlands

Location

Department of Rheumatology, Diakonhjemmet Hospital

Oslo, N-0027, Norway

Location

Related Publications (2)

• Sepriano A, Ramiro S, FitzGerald O, Ostergaard M, Homik J, van der Heijde D, Elkayam O, Thorne JC, Larche MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Landewe R, Maksymowych WP. Adherence to Treat-to-target Management in Rheumatoid Arthritis and Associated Factors: Data from the International RA BIODAM Cohort. J Rheumatol. 2020 Jun 1;47(6):809-819. doi: 10.3899/jrheum.190303. Epub 2019 Sep 15.

  PMID: 31523049 DERIVED

• Maksymowych WP, FitzGerald O, Ostergaard M, Homik J, van der Heijde D, Lambert RG, Elkayam O, Ramiro S, Thorne JC, Larche MJ, Ferraccioli G, Backhaus M, Burmester GR, Boire G, Combe B, Schaeverbeke T, Saraux A, Dougados M, Rossini M, Govoni M, Sinigaglia L, Cantagrel A, Barnabe C, Bingham CO 3rd, Tak PP, van Schaardenburg D, Hammer HB, Paschke J, Dadashova R, Hutchings E, Sepriano A, Landewe R. Outcomes and Findings of the International Rheumatoid Arthritis (RA) BIODAM Cohort for Validation of Soluble Biomarkers in RA. J Rheumatol. 2020 Jun 1;47(6):796-808. doi: 10.3899/jrheum.190302. Epub 2019 Sep 1.

  PMID: 31474600 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

* whole blood/serum * urine

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Observation

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Walter P. Maksymowych, MD

  CaRE Arthritis

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: November 22, 2011
• Study Start: October 1, 2011
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2019
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

DK (1); CA (7); DE (4); IT (6); IE (1); NO (1); IL (1); FR (6); NL (4); US (5)