Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centro Hospitalar Lisboa Ocidental | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Ankylosing spondylitis (AS), Rheumatoid Arthritis (RA) and Systemic Lupus Erythematosus (SLE) are three diseases where early diagnosis remains a major challenge. However, early diagnosis is the main determinant for a better prognosis. In the early stage, symptoms may be nonspecific and often difficult to establish a differential diagnosis between rheumatic diseases and other diseases, namely infectious and cancer diseases.
The management of these diseases has undergone major advances in recent years, both in terms of the drugs armamentarium and therapeutic strategy. Treating disease to target, aiming at remission, through a tight control protocol is regarded as the standard of care. These principles were imported from RA and became the main strategy to approach several rheumatic inflammatory diseases. Reaching clinical and radiographic disease remission has therefore become an achievable goal. Increasing evidence has demonstrated that early diagnosis, prompt treatment initiation and early achievement of remission are the major predictors of good long-term clinical, functional and radiographic outcomes. The main reason for diagnostic delays is that classification criteria sets, including, imaging or biochemical changes, require time to occur. Rheumatoid factor, anti-CCP, ANA, anti-DNA and anti-Sm autoantibodies are often negative in the early stages of the disease; HLA B27 gene has a low specificity for AS. New criteria are now available and some biomarkers are emerging that allow earlier patient diagnosis. This new paradigm, needs new research trying to identify the most reliable biomarkers with relevance for clinical use.
The investigators intend to analyse biological samples, peripheral blood, from patients with well-established diagnosis (34 AS, 34 RA and 34 SLE) and 34 healthy controls (crossed by gender and age). Laboratory analysis will be based on transcriptomic approach trying to put in evidence specific biomarkers for each disease. The method is based on a analytical methodology already proven with success in stratifying patients.
The main objective of this study will be the development of a diagnostic chip to be implemented in clinical practice. The results should be confirmed in the same set of patients using quantitative real-time protein chain reaction (RT-PCR) and the validation in a new set of patients. The main objective of this project is to establish a quick method to stratify patients of the three diseases- AS, SLE, RA.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | |||
| Ankylosing Spondylitis | |||
| Rheumatic Arthritis | |||
| Systemic Lupus Erythematosus |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Identify a transcriptomic signature to optimize patient stratification (between AS, RA and SLE) | From enrollment to the end of the study at 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Identify novel signaling pathways that may represent new therapeutic targets | From enrollment to the end of the study at 12 weeks. | |
| Compare transcriptomic signatures in different levels of disease activity | From enrollment to the end of the study at 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
People that satisfy the eligibity criteria with AS, RA, SLE and healthy individuals (as controls) currently living in Portugal.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fernando Pimentel-Santos, PhD Agg | Contact | 00351917305093 | pimentel.santos@nms.unl.pt | |
| Ian Lopes Teixeira, MSc | Contact | 00351926234952 | ian.teixeira@nms.unl.pt |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ULS Lisboa Ocidental, Hospital de Egas Moniz | Recruiting | Lisbon | 1349-019 Lisboa | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21470430 | Result | Pimentel-Santos FM, Ligeiro D, Matos M, Mourao AF, Costa J, Santos H, Barcelos A, Godinho F, Pinto P, Cruz M, Fonseca JE, Guedes-Pinto H, Branco JC, Brown MA, Thomas GP. Whole blood transcriptional profiling in ankylosing spondylitis identifies novel candidate genes that might contribute to the inflammatory and tissue-destructive disease aspects. Arthritis Res Ther. 2011 Apr 7;13(2):R57. doi: 10.1186/ar3309. | |
| 19208593 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D012213 | Rheumatic Fever |
| D008180 | Lupus Erythematosus, Systemic |
| D004194 | Disease |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
Not provided
Not provided
Not provided
Not provided
Not provided
Peripheral Blood Samples
| Result |
| Eilertsen GO, Becker-Merok A, Nossent JC. The influence of the 1997 updated classification criteria for systemic lupus erythematosus: epidemiology, disease presentation, and patient management. J Rheumatol. 2009 Mar;36(3):552-9. doi: 10.3899/jrheum.080574. Epub 2009 Jan 22. |
| 20967854 | Result | van der Linden MP, Knevel R, Huizinga TW, van der Helm-van Mil AH. Classification of rheumatoid arthritis: comparison of the 1987 American College of Rheumatology criteria and the 2010 American College of Rheumatology/European League Against Rheumatism criteria. Arthritis Rheum. 2011 Jan;63(1):37-42. doi: 10.1002/art.30100. |
| 6608352 | Result | van der Linden SM, Valkenburg HA, de Jongh BM, Cats A. The risk of developing ankylosing spondylitis in HLA-B27 positive individuals. A comparison of relatives of spondylitis patients with the general population. Arthritis Rheum. 1984 Mar;27(3):241-9. doi: 10.1002/art.1780270301. |
| 24573911 | Result | Oglesby A, Korves C, Laliberte F, Dennis G, Rao S, Suthoff ED, Wei R, Duh MS. Impact of early versus late systemic lupus erythematosus diagnosis on clinical and economic outcomes. Appl Health Econ Health Policy. 2014 Apr;12(2):179-90. doi: 10.1007/s40258-014-0085-x. |
| 26557378 | Result | Monti S, Montecucco C, Bugatti S, Caporali R. Rheumatoid arthritis treatment: the earlier the better to prevent joint damage. RMD Open. 2015 Aug 15;1(Suppl 1):e000057. doi: 10.1136/rmdopen-2015-000057. eCollection 2015. |
| 23578940 | Result | Wendling D, Claudepierre P, Prati C. Early diagnosis and management are crucial in spondyloarthritis. Joint Bone Spine. 2013 Dec;80(6):582-5. doi: 10.1016/j.jbspin.2013.03.003. Epub 2013 Apr 8. |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |