Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

CARE ARTHRITIS LTD.

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: Observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT01476956

RA BIODAM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 571 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

571 participants in 1 patient group

Rheumatoid Arthritis

Treatment:

Other: Observational study