Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
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| ClinicalTrials.gov Identifier: NCT01476956 |
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Recruitment Status :
Active, not recruiting
First Posted : November 22, 2011
Last Update Posted : November 18, 2016
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Rheumatoid Arthritis | Other: Observational study |
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Prospective Validation of Soluble Biomarkers as Predictors of Structural Damage in Rheumatoid Arthritis |
| Study Start Date : | October 2011 |
| Estimated Primary Completion Date : | April 2017 |
| Estimated Study Completion Date : | December 2017 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Rheumatoid Arthritis |
Other: Observational study
RA patients on standard DMARD therapy |
- To determine the independent predictive validity of several soluble biomarkers for predicting structural damage in Rheumatoid Arthritis (RA). [ Time Frame: 24 Months ]
- To establish which modifiable clinical and laboratory predictors used in routine practice individually and in combination, have the strongest and the most consistent association with change in radiographic damage in patients on standard RA therapy. [ Time Frame: 24 Months ]
Biospecimen Retention: Samples Without DNA
- whole blood/serum
- urine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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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)
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476956
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| Study Director: | Walter P. Maksymowych, MD | CaRE Arthritis |
| Responsible Party: | Canadian Research & Education in Arthritis |
| ClinicalTrials.gov Identifier: | NCT01476956 History of Changes |
| Other Study ID Numbers: |
RA BIODAM |
| First Posted: | November 22, 2011 Key Record Dates |
| Last Update Posted: | November 18, 2016 |
| Last Verified: | July 2016 |
Additional relevant MeSH terms:
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Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |