Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF)
Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. To address this issue the Spanish Society of Rheumat...
| Authors: | ; ; ; ; ; ; ; ; ; |
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| Format: | Article |
| Publication date: | 2015 |
| Country: | España |
| Institution: | Universitat Autònoma de Barcelona |
| Repository: | Dipòsit Digital de Documents de la UAB |
| Language: | English |
| OAI Identifier: | oai:ddd.uab.cat:185402 |
| Online Access: | https://ddd.uab.cat/record/185402 https://dx.doi.org/urn:doi:10.1186/s13063-015-0828-5 |
| Access Level: | Open access |
| Keyword: | Spondyloarthritis/therapy DMARDs (biologic) Disease Activity Treatment |
| _version_ | 1878730078092787713 |
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| author | Pontes García, Caridad|||0000-0002-3274-6048 |
| author2 | Gratacós, Jordi|||0000-0003-4007-4103 Torres, Ferran|||0000-0002-7355-7913 Avendaño Sola, Cristina|||0000-0001-5437-7215 Sanz, Jesús Vallano, Antoni|||0000-0002-3648-3492 Juanola, Xavier|||0000-0001-5998-6300 de Miguel, Eugenio|||0000-0001-5146-1964 Sanmartí, Raimon|||0000-0002-8864-3806 Calvo Rojas, Gonzalo|||0000-0001-8860-6653 |
| author2_role | author author author author author author author author author |
| author_browse | Avendaño Sola, Cristina|||0000-0001-5437-7215 Calvo Rojas, Gonzalo|||0000-0001-8860-6653 Gratacós, Jordi|||0000-0003-4007-4103 Juanola, Xavier|||0000-0001-5998-6300 Pontes García, Caridad|||0000-0002-3274-6048 Sanmartí, Raimon|||0000-0002-8864-3806 Sanz, Jesús Torres, Ferran|||0000-0002-7355-7913 Vallano, Antoni|||0000-0002-3648-3492 de Miguel, Eugenio|||0000-0001-5146-1964 |
| author_facet | Pontes García, Caridad|||0000-0002-3274-6048 Gratacós, Jordi|||0000-0003-4007-4103 Torres, Ferran|||0000-0002-7355-7913 Avendaño Sola, Cristina|||0000-0001-5437-7215 Sanz, Jesús Vallano, Antoni|||0000-0002-3648-3492 Juanola, Xavier|||0000-0001-5998-6300 de Miguel, Eugenio|||0000-0001-5146-1964 Sanmartí, Raimon|||0000-0002-8864-3806 Calvo Rojas, Gonzalo|||0000-0001-8860-6653 |
| author_role | author |
| collection | Dipòsit Digital de Documents de la UAB |
| description | Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. To address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015. The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers. EudraCT (21 December 2011) The online version of this article (doi:10.1186/s13063-015-0828-5) contains supplementary material, which is available to authorized users. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_14ebfc33a75fa0c389fdfad8a23a704d |
| institution | Universitat Autònoma de Barcelona |
| instname_str | Universitat Autònoma de Barcelona |
| language | eng |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:ddd.uab.cat:185402 |
| publishDate | 2015 |
| publishDateSort | 2015 |
| reponame_str | Dipòsit Digital de Documents de la UAB |
| spelling | Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF) study protocol for a randomized controlled trial Pontes García, Caridad|||0000-0002-3274-6048 Gratacós, Jordi|||0000-0003-4007-4103 Torres, Ferran|||0000-0002-7355-7913 Avendaño Sola, Cristina|||0000-0001-5437-7215 Sanz, Jesús Vallano, Antoni|||0000-0002-3648-3492 Juanola, Xavier|||0000-0001-5998-6300 de Miguel, Eugenio|||0000-0001-5146-1964 Sanmartí, Raimon|||0000-0002-8864-3806 Calvo Rojas, Gonzalo|||0000-0001-8860-6653 Spondyloarthritis/therapy DMARDs (biologic) Disease Activity Treatment Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. To address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015. The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers. EudraCT (21 December 2011) The online version of this article (doi:10.1186/s13063-015-0828-5) contains supplementary material, which is available to authorized users. https://ddd.uab.cat/record/185402 https://dx.doi.org/urn:doi:10.1186/s13063-015-0828-5 |
| spellingShingle | Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF) Pontes García, Caridad|||0000-0002-3274-6048 Spondyloarthritis/therapy DMARDs (biologic) Disease Activity Treatment |
| title | Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF) |
| title_full | Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF) |
| title_fullStr | Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF) |
| title_full_unstemmed | Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF) |
| title_short | Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF) |
| title_sort | Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF) |
| topic | Spondyloarthritis/therapy DMARDs (biologic) Disease Activity Treatment |
| topic_facet | Spondyloarthritis/therapy DMARDs (biologic) Disease Activity Treatment |
| url | https://ddd.uab.cat/record/185402 https://dx.doi.org/urn:doi:10.1186/s13063-015-0828-5 |