COBRA-Slim with or without fast access to TNF blockade for remission induction in early rheumatoid arthritis (RA) – The CareRA 2020 Study (KCE-16002)

Summary (French or Dutch)

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.

Trial Description
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)

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)

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

Control (C)

Routine care (= adding leflunomide 10 mg daily as the next step in the treatment adaptation scheme of the COBRA Slim regimen)

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

Trial Design

Multicenter, 1:1 randomized, parallel-group trial of 2-year duration followed by a 3-year observational longitudinal follow-up trial

Sample Size

442 patients of which 90 patients are expected to be randomized after insufficient response

Trial duration

4 years (2 year recruitment + 2 year treatment and follow-up) in CareRA2020 followed by 3 years long term follow-up

Budget

€ 4 101 648 (incl. VAT)

Status

Open to recruitment

 

Trial team

Sponsor

UZ Leuven – KU Leuven

Chief Investigator

Prof Dr Patrick Verschueren

Department of Rheumatology, University Hospitals Leuven

Trial coordinator

Johan Joly

Department of Rheumatology, University Hospitals Leuven

Documents
Protocol Download here (not yet available)
Report

1st report expected for Q2 2022

2nd report with follow-up data expected for Q2 2025
Publication

1st publication expected for Q3 2022

2nd publication with follow-up data expected for Q2 2025
References

ClinicalTrials.gov: pending

EudraCT: 2017-004054-41

Webpage: not yet active

Funding scheme

Commissioning workstream 2016