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| Name | Class |
|---|---|
| Rennes University Hospital | OTHER |
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Rheumatoid arthritis (RA) is a chronic inflammatory disease mediated by the production of several cytokines, which leads to the destruction of bone and cartilage tissue in multiple joints and to bone loss. Conventional radiographs (CR) are considered as the gold standard for diagnosis and follow up of joint changes in RA. But this method has low sensitivity to detect early erosive changes and is unable to evaluate periarticular bone loss.
High Resolution peripheral QCT (HRpQCT) enables the detection of erosions less than 0.5 mm in width or depth at metacarpo-phalangeal (MCP) joints. Using 3-D high resolution analysis of cortical bone erosions, this one is also able to evaluate the volumes of erosion and the evolution under treatments IL6 (6- interleukin) plays a major role in inflammatory process and bone damages related to RA. Tocilizumab (TCZ) is a humanized anti-IL-6R monoclonal antibody, developed and investigated in several clinical trials in RA. This biotherapy, in association with methotrexate (MTX) or given in monotherapy, is efficient in RA with inadequate response to MTX or anti-TNF b (tumor necrosis factor). TCZ reduces dramatically systemic inflammation, structural progression and improves clinical symptoms and quality of life.
Tocilizumab may help reducing bone erosions, periarticular osteopenia and systemic bone loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roactemra | Experimental | subcutaneous tocilizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subcutaneous tocilizumab | Drug | 162 mg subcutaneous, once a week during 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone erosion change after 12 months of subcutaneous tocilizumab | changes of width measured by HRpQCT. | baseline and 12 months |
| Bone erosion change after 12 months of subcutaneous tocilizumab | changes of depth measured by HRpQCT. | baseline and 12 months |
| Bone erosion change after 12 months of subcutaneous tocilizumab | changes of volume measured by HRpQCT. | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Associated factors with erosion changes assessed by HRqQCT | Number of participants with associated factors with erosion changes by HRpQCT (Associated therapeutic, clinical and biological response )ultrasound ...) | baseline, 3 months, 12 months |
| Effect of 12 months of tocilizumab on bone density in the PR |
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Inclusion Criteria:
Exclusion Criteria:
Treatment with zoledronic acid or denosumab (less than one year)
General:
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| Name | Affiliation | Role |
|---|---|---|
| SALLIOT Carine, MD | CHR ORLEANS | Study Director |
| LESPESSAILLES Eric, MD, PhD | CHR ORLEANS | Principal Investigator |
| CANTAGREL Alain, MD, PhD | University Hospital, Toulouse | Principal Investigator |
| CHAPURLAT Roland, MD, PhD | Hospices Civils de Lyon | Principal Investigator |
| MAROTTE Hubert, MD, PhD | HOPITAL NORD SAINT ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Edouard HERIOT | Lyon | 69437 | France | |||
| CHR d'ORLEANS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16189253 | Background | Boutroy S, Bouxsein ML, Munoz F, Delmas PD. In vivo assessment of trabecular bone microarchitecture by high-resolution peripheral quantitative computed tomography. J Clin Endocrinol Metab. 2005 Dec;90(12):6508-15. doi: 10.1210/jc.2005-1258. Epub 2005 Sep 27. | |
| 20112404 | Background | Stach CM, Bauerle M, Englbrecht M, Kronke G, Engelke K, Manger B, Schett G. Periarticular bone structure in rheumatoid arthritis patients and healthy individuals assessed by high-resolution computed tomography. Arthritis Rheum. 2010 Feb;62(2):330-9. doi: 10.1002/art.27252. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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Changes of Bone mineral density by DXA at the lumbar spine and proximal femur |
| baseline, 12 months |
| Effect of Tocilizumab on synovitis/tenosynovitis assessed by US and agreement with disease activity scores | Correlation Between clinical activity measured by various indices (Disease Activity Score 28, Clinical Disease Activity Iindex , Simplify Disease Activity Index , American College of Rheumatology - European League against Rheumatism: ACR EULAR) and ultrasound data. | Predictors baseline, 1 and 3 months of clinical remission and / or ultrasound at 6 and 12 months |
| Effect of 12 months of tocilizumab on bone microarchitecture in the PR | changes of bone microarchitecture by tibia HRpQCT | baseline, 12 months |
| Orléans |
| 45067 |
| France |
| Hopital Nord CHU de SAint ETIENNE | Saint-Etienne | France |
| Chu Toulouse | Toulouse | France |
| 20525847 | Background | Fouque-Aubert A, Boutroy S, Marotte H, Vilayphiou N, Bacchetta J, Miossec P, Delmas PD, Chapurlat RD. Assessment of hand bone loss in rheumatoid arthritis by high-resolution peripheral quantitative CT. Ann Rheum Dis. 2010 Sep;69(9):1671-6. doi: 10.1136/ard.2009.114512. Epub 2010 Jun 4. |
| 24614646 | Background | Ellouz R, Chapurlat R, van Rietbergen B, Christen P, Pialat JB, Boutroy S. Challenges in longitudinal measurements with HR-pQCT: evaluation of a 3D registration method to improve bone microarchitecture and strength measurement reproducibility. Bone. 2014 Jun;63:147-57. doi: 10.1016/j.bone.2014.03.001. Epub 2014 Mar 12. |
| 19019887 | Background | Moller Dohn U, Boonen A, Hetland ML, Hansen MS, Knudsen LS, Hansen A, Madsen OR, Hasselquist M, Moller JM, Ostergaard M. Erosive progression is minimal, but erosion healing rare, in patients with rheumatoid arthritis treated with adalimumab. A 1 year investigator-initiated follow-up study using high-resolution computed tomography as the primary outcome measure. Ann Rheum Dis. 2009 Oct;68(10):1585-90. doi: 10.1136/ard.2008.097048. Epub 2008 Nov 19. |
| 21622765 | Background | Finzel S, Rech J, Schmidt S, Engelke K, Englbrecht M, Stach C, Schett G. Repair of bone erosions in rheumatoid arthritis treated with tumour necrosis factor inhibitors is based on bone apposition at the base of the erosion. Ann Rheum Dis. 2011 Sep;70(9):1587-93. doi: 10.1136/ard.2010.148395. Epub 2011 May 27. |
| 19435723 | Background | Dohn UM, Ostergaard M, Bird P, Boonen A, Johansen JS, Moller JM, Hansen MS. Tendency towards erosive regression on magnetic resonance imaging at 12 months in rheumatoid arthritis patients treated with rituximab. Ann Rheum Dis. 2009 Jun;68(6):1072-3. doi: 10.1136/ard.2008.098962. No abstract available. |
| 20980282 | Background | Dohn UM, Ejbjerg B, Boonen A, Hetland ML, Hansen MS, Knudsen LS, Hansen A, Madsen OR, Hasselquist M, Moller JM, Ostergaard M. No overall progression and occasional repair of erosions despite persistent inflammation in adalimumab-treated rheumatoid arthritis patients: results from a longitudinal comparative MRI, ultrasonography, CT and radiography study. Ann Rheum Dis. 2011 Feb;70(2):252-8. doi: 10.1136/ard.2009.123729. Epub 2010 Oct 26. |
| 22586162 | Background | Finzel S, Rech J, Schmidt S, Engelke K, Englbrecht M, Schett G. Interleukin-6 receptor blockade induces limited repair of bone erosions in rheumatoid arthritis: a micro CT study. Ann Rheum Dis. 2013 Mar;72(3):396-400. doi: 10.1136/annrheumdis-2011-201075. Epub 2012 May 14. |
| 20039425 | Background | Garnero P, Thompson E, Woodworth T, Smolen JS. Rapid and sustained improvement in bone and cartilage turnover markers with the anti-interleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone. Arthritis Rheum. 2010 Jan;62(1):33-43. doi: 10.1002/art.25053. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |