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Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis

18 Years
Open (Enrolling)
Rheumatoid Arthritis

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Trial Information

Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis

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.

Inclusion 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

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,

- 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

- 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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

24 Months

Safety Issue:


Principal Investigator

Walter P. Maksymowych, MD

Investigator Role:

Study Director

Investigator Affiliation:

CaRE Arthritis


Canada: Ethics Review Committee

Study ID:




Start Date:

October 2011

Completion Date:

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid



Albany, New York  12208
Seattle, Washington  98195
Baltimore, Maryland  21287