Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography

Status:	Active, not recruiting
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	7/19/2018
Start Date:	October 2011
End Date:	December 2019

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

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.

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 (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

We found this trial at

sites

Johns Hopkins Arthritis Center, Johns Hopkins University

Baltimore, Maryland 21224

from

Baltimore, MD