Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CARE ARTHRITIS LTD.
With
Abbott
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be 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
Clareo Health | Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
