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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The aim of this study is to examine the associations between inflammatory disease activity and endothelial function in rheumatoid arthritis (RA) and spondyloarthritis patients treated with methotrexate and Tumor Necrosis Factor alpha (TNFalpha)inhibitor in combination or methotrexate or TNFalpha-inhibitor alone. Further, to look for improvement in endothelial function, and decrease in bone and cartilage destruction during treatment with the combination therapy of TNFalpha-inhibitor and methotrexate in RA and Psoriatic Arthritis (PSA) patients. Last, examine the TNFalpha inhibitors influence on endothelial function and levels of bone and cartilage markers in patients with Ankylosing Spondylitis (AS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatic patients | Three groups: RA patients: 30 starting on Methotrexate, 30 starting on combination of Methotrexate and TNFalpha inhibitor. PSA patients: 20 starting on Methotrexate, 20 starting on combination of Methotrexate and TNFalpha inhibitor. AS patients: 20 starting on TNFalpha inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| To examine the association between inflammatory disease activity and endothelial function in RA and spondyloarthritis patients treated with methotrexate and TNFalpha-inhibitor in combination or methotrexate or TNFalpha-inhibitor alone | Baseline (before treatment starts), 6 weeks and 6 months after starting treatment |
| Measure | Description | Time Frame |
|---|---|---|
| CRP (C-reactive protein) | Baseline (before starting treatment), 6 weeks, 6 months after starting treatment | |
| DAS28 (Disease activity score) | Baseline (before starting treatment), 6 weeks, 6 months after starting treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with RA and spondyloarthritis starting with either combination therapy of TNFalpha-inhibitor and methotrexate or methotrexate or TNFalpha-inhibitor alone, at Lillehammer Hospital for Rheumatic diseases.Decision about treatment modality will be based on conventional clinial judgement.
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| Name | Affiliation | Role |
|---|---|---|
| Knut Mikkelsen, MD | Lillehammer Hospital for Rheumatic Diseases | Study Chair |
| Gunnbjørg Hjeltnes, MD | Lillehammer Hospital for Rheumatic Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lillehammer Hospital for Rheumatic Diseases | Lillehammer | Oppland | 2609 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31335881 | Derived | Hokstad I, Deyab G, Wang Fagerland M, Lyberg T, Hjeltnes G, Forre O, Agewall S, Mollnes TE, Hollan I. Tumor necrosis factor inhibitors are associated with reduced complement activation in spondylarthropathies: An observational study. PLoS One. 2019 Jul 23;14(7):e0220079. doi: 10.1371/journal.pone.0220079. eCollection 2019. | |
| 29041979 |
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Whole blood
| COMP (cartilage oligomeric matrix protein 1) | Baseline (before starting treatment), 6 weeks, 6 months after starting treatment |
| IL-6 (interleukin 6) | Baseline (before starting treatment), 6 weeks, 6 months after starting treatment |
| s-RAGE (Receptor of Advanced Glycation End products) | Baseline (before starting treatment), 6 weeks, 6 months after starting treatment |
| Deyab G, Hokstad I, Whist JE, Smastuen MC, Agewall S, Lyberg T, Ronda N, Mikkelsen K, Hjeltnes G, Hollan I. Methotrexate and anti-tumor necrosis factor treatment improves endothelial function in patients with inflammatory arthritis. Arthritis Res Ther. 2017 Oct 17;19(1):232. doi: 10.1186/s13075-017-1439-1. |
| 25605003 | Derived | Ronda N, Greco D, Adorni MP, Zimetti F, Favari E, Hjeltnes G, Mikkelsen K, Borghi MO, Favalli EG, Gatti R, Hollan I, Meroni PL, Bernini F. Newly identified antiatherosclerotic activity of methotrexate and adalimumab: complementary effects on lipoprotein function and macrophage cholesterol metabolism. Arthritis Rheumatol. 2015 May;67(5):1155-64. doi: 10.1002/art.39039. |
| 22660798 | Derived | Hjeltnes G, Hollan I, Forre O, Wiik A, Lyberg T, Mikkelsen K, Agewall S. Relations of serum COMP to cardiovascular risk factors and endothelial function in patients with rheumatoid arthritis treated with methotrexate and TNF-alpha inhibitors. J Rheumatol. 2012 Jul;39(7):1341-7. doi: 10.3899/jrheum.111401. Epub 2012 Jun 1. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |
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