Status:
COMPLETED
Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
Lead Sponsor:
CARE ARTHRITIS LTD.
Collaborating Sponsors:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
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 mo...
Detailed 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 wh...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT01476956
Start Date
October 1 2011
End Date
December 31 2019
Last Update
October 27 2021
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Arthritis Center, Johns Hopkins University
Baltimore, Maryland, United States, 21224
2
Rheumatologist Hospital for Special Surgery
New York, New York, United States, 10021
3
Division of Rheumatology, Columbia University, College of Physicians and Surgeons
New York, New York, United States, 10032
4
Division of Allergy, Immunology and Rheumatology, University of Rochester
Rochester, New York, United States, 14642