KCE-16002: COBRA-Slim mit oder ohne verkürzten Zugang zu Anti-TNF zur Remissionsinduktion bei Patienten mit früher rheumatoider Arthritis (RA) - Studie CareRA 2020

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

Closed to recruitment – in follow up 

 

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

Dokumente
Protocol

CareRa2020 RCT protocol

CareRa2020 LTE protocol

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
Referenzen

ClinicalTrials.gov: NCT03649061

EudraCT: 2017-004054-41

Webpage: not yet active

FINANZIERUNGSSCHEMA

Commissioning workstream 2016