This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment observational study
Sponsor Canadian Research & Education in Arthritis
Collaborator Abbott
Start date October 2011
End date April 2017
Trial size 600 participants
Trial identifier NCT01476956, RA BIODAM


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
observational study
RA patients on standard DMARD therapy

Primary Outcomes

To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA).
time frame: 24 Months

Secondary Outcomes

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.
time frame: 24 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria (selected): - 18 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 Exclusion Criteria (selected): - 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

Additional Information

Official title Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Canadian Research & Education in Arthritis.