Early rheumatoid arthritis (RA) therapy has much improved but only 70% of patients respond to the current benchmark strategy, combining methotrexate with a glucocorticoid step-down regimen (Cobra Slim). Non-responders can have treatment intensification by switching to biologicals (agents of the latest generation such as TNF-blockers), but these are expensive and not currently reimbursed in this setting.
The objective of the CareRA 2020 study is to investigate if the management of RA could be improved by accelerated access to a 6-month course of biologicals soon after disease onset, compared to gradually stepping-up in the case of conventional treatment failure. For this purpose we will compare the efficacy and cost-effectiveness of two treatment strategies. A first group will follow the Cobra Slim schedule, stepping up if necessary to a TNF-blocker according to current reimbursement rules. A second group will have accelerated access to a TNF-blocker for 6 months, in the case of insufficient response to Cobra Slim (measured from 8 to 32 weeks after starting Cobra Slim treatment).
The reasoning behind this study is that a rapid but short-term access to biologicals in RA patients who cannot be adequately treated with standard therapy in the critical first months, will lead to improved disease control and reduced need for long term use of these expensive compounds.
| Summary of results |
|---|
| This randomised controlled trial followed 110 patients whose rheumatoid arthritis (RA) was not well controlled after initial treatment. After 2 years, there was no difference in disease control, functional disability, radiographic joint damage, overall impact of RA on the patient, or work status between the group that received standard treatment (adding leflunomide) and the group that received an early and temporary addition of a biologic treatment (etanercept). However, patients who received the early addition of etanercept had faster disease control compared with the addition of leflunomide. A three-year follow-up of all patients is ongoing to confirm longer-term outcomes. |
| Title |
CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to six months of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial, followed by a 3 year longitudinal observational, multicenter, follow-up of early RA patients after participation in CareRA2020. (KCE-16002) |
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Participants (P) |
Patients with early RA (diagnosis < 1 year, according to the 2010 EULAR/ACR criteria), that have not yet been treated with Disease Modifying Anti-rheumatic Drugs (DMARDs) |
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Intervention (I) |
Etanercept (or biosimilar) 50 mg Subcutaneous (SC) weekly for a period of 24 weeks in insufficient responders after 1st treatment course with COBRA Slim regimen |
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Control (C) |
Routine care (= adding leflunomide 10 mg daily as the next step in the treatment adaptation scheme of the COBRA Slim regimen) |
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Outcome (O) |
Area under the curve of DAS28CRP over 104 weeks (long term effectiveness) in insufficient responders randomized to either COBRA-Slim Bio-Induction or Standard COBRA-Slim induction |
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Trial Design |
Multicenter, 1:1 randomized, parallel-group trial of 2-year duration followed by a 3-year observational longitudinal follow-up trial |
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Sample Size |
442 patients of which 90 patients are expected to be randomized after insufficient response |
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Trial duration |
4 years (2 year recruitment + 2 year treatment and follow-up) in CareRA2020 followed by 3 years long term follow-up |
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Budget |
€ 4 101 648 (incl. VAT) |
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Sponsor |
UZ Leuven – KU Leuven |
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Chief Investigator |
Prof Dr Patrick Verschueren Department of Rheumatology, University Hospitals Leuven |
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Trial coordinator |
Johan Joly Department of Rheumatology, University Hospitals Leuven |
| Protocol | Download RCT protocol Download LTE protocol |
| Results | View publication RMD Open |
For timelines and recruitment, see dashboard
Commissioning workstream 2016
