drugset / Trial / NCT01295151
SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.
RandomizedParallel-groupOpen-labelTreatment
Summary
The principal aim of this study is to fill a clear knowledge gap and provide guidance for rheumatologists and reassurance to the patient group on a management challenge faced daily in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal management of patients with established RA that have failed an anti-TNF therapy (the first of the biological therapies to be introduced); in particular, the investigators wish to address whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is to broaden treatment options and target these specific therapies to disease sub-groups.
Timeline
- Start
- 2011-08
- Primary completion
- 2015-11
- Completion
- 2015-11
Publications
- Plein S, Erhayiem B, Fent G, Horton S, Dumitru RB, Andrews J, Greenwood JP, Emery P, Hensor EM, Baxter P, Pavitt S, Buch MH. Cardiovascular effects of biological versus conventional synthetic disease-modifying antirheumatic drug therapy in treatment-naive, early rheumatoid arthritis. Ann Rheum Dis. 2020 Nov;79(11):1414-1422. doi: 10.1136/annrheumdis-2020-217653. Epub 2020 Aug 28.
- Brown S, Everett CC, Naraghi K, Davies C, Dawkins B, Hulme C, McCabe C, Pavitt S, Emery P, Sharples L, Buch MH. Alternative tumour necrosis factor inhibitors (TNFi) or abatacept or rituximab following failure of initial TNFi in rheumatoid arthritis: the SWITCH RCT. Health Technol Assess. 2018 Jun;22(34):1-280. doi: 10.3310/hta22340.
- Navarro Coy NC, Brown S, Bosworth A, Davies CT, Emery P, Everett CC, Fernandez C, Gray JC, Hartley S, Hulme C, Keenan AM, McCabe C, Redmond A, Reynolds C, Scott D, Sharples LD, Pavitt S, Buch MH. The 'Switch' study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug. BMC Musculoskelet Disord. 2014 Dec 23;15:452. doi: 10.1186/1471-2474-15-452.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abatacept | Other / unclassified | 500 mg | Intravenous |
| Subject | Abatacept | Other / unclassified | 750 mg | Intravenous |
| Subject | Abatacept | Other / unclassified | 1000 mg | Intravenous |
| Subject | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Certolizumab Pegol | Protein / enzyme biologic | 200 mg | Subcutaneous |
| Subject | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Subject | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | Infliximab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 1000 mg | Intravenous |