COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA
NCT ID: NCT03649061
Last Updated: 2025-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
276 participants
INTERVENTIONAL
2018-06-08
2022-07-01
Brief Summary
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Interesting to see is that the 30% of insufficient responders can be identified in an early stage of the treatment course.
The purpose of the present study is to investigate if, for patients with an insufficient response to a COBRA-Slim regimen, accelerated access to a short course of anti-TNF therapy already early after treatment initiation (from w8 until w32) could improve outcomes compared to a more traditional treat to target sequence.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Randomization will be balanced according to time-point of randomization, baseline (BL) disease activity and Anti-Citrullinated Protein Antibody (ACPA) and Rheumatoid Factor (RF) status to ensure comparability of the treatment groups with respect to these prognostic variables.
TREATMENT
NONE
Study Groups
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standard COBRA-Slim induction
Leflunomide 10mg PO daily added to the COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Leflunomide 10 milligram (MG)
Leflunomide 10mg PO daily added to the COBRA-Slim scheme
COBRA-Slim Bio-induction
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme (Methotrexate 15 mg PO weekly, Step down scheme of GC: 30-20-12,5-10-7,5-5 mg prednisone PO daily, each for 7 days except for the lowest dose of 5 mg, this will be maintained until w28 and then tapered to 2.5 mg daily for two weeks before stopping completely.)
Etanercept 50 MG/ML
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
Interventions
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Etanercept 50 MG/ML
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
Leflunomide 10 milligram (MG)
Leflunomide 10mg PO daily added to the COBRA-Slim scheme
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of RA as defined by the American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010 criteria for early RA
* Early RA defined by a diagnosis made ≤ 1 year ago.
* Use a reliable method of contraception for women of childbearing potential to be evaluated as in daily clinical practice
* Able and willing to give written informed consent and to participate in the study
* Understanding and able to write Dutch or French
Exclusion Criteria
* Methotrexate (MTX) or leflunomide
* cyclophosphamide, azathioprine or cyclosporine
* sulphasalazine (SSZ) for more than 3 weeks
* hydroxychloroquine for more than 6 weeks
* oral Glucocorticoids (GC) for more than 4 weeks within 4 months before screening
* oral GC at a daily dosage of more than 10 mg prednisone equivalent within 4 weeks before baseline
* oral GC at a daily dosage equal to or less than 10 mg prednisone equivalent within 2 weeks before baseline
* intra-articular GC within 4 weeks before BL
* an investigational drug for the treatment/prevention of RA
* History of chronic heart failure
* History of severe infections or chronic infection
* History of malignant neoplasm within 5 years
* Contra indications for GC
* Contra indications for TNF blocking agents
* Contra indications for MTX or leflunomide
* Psoriatic Arthritis
* Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
* Pregnancy, breastfeeding or no use of a reliable method of contraception for woman of childbearing potential (as in daily clinical practice)
* Alcohol or drug abuse
* Active tuberculosis (TB)
* Latent TB unless adequate prophylactic treatment is given according to local guidelines
* No access to the Belgian Health Insurance system-
18 Years
ALL
No
Sponsors
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Belgium Health Care Knowledge Centre
OTHER_GOV
P. Verschueren
OTHER
Responsible Party
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P. Verschueren
Prof. Dr.
Principal Investigators
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Patrick Verschueren, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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Imelda Ziekenhuis Bonheiden
Bonheiden, Antwerpen, Belgium
AZ Herentals
Herentals, Antwerpen, Belgium
ZNA Jan Palfijn
Merksem, Antwerpen, Belgium
GHdC Saint Joseph
Gilly, Henegouwen, Belgium
Reuma centrum Genk
Genk, Limburg, Belgium
Reuma Clinic Genk
Genk, Limburg, Belgium
Reuma Instituut Hasselt
Hasselt, Limburg, Belgium
CHU UCL Namur ASBL Site Godinne
Yvoir, Namur, Belgium
OLV Ziekenhuis Aalst
Aalst, Oost Vlaanderen, Belgium
Regionaal Ziekenhuis Heilig Hart Leuven
Leuven, Vlaams Brabant, Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium
AZ Jan Portaels
Vilvoorde, Vlaams Brabant, Belgium
AZ St Lucas Brugge
Bruges, West Vlaanderen, Belgium
AZ Sint Jan Brugge
Bruges, West-Vlaanderen, Belgium
CHU Saint Pierre
Brussels, , Belgium
Cliniques Universitaire Saint Luc (UCL)
Brussels, , Belgium
Hôpital Erasme-ULB
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
CHU Liège
Liège, , Belgium
Countries
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References
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Van der Elst K, De Cock D, Vecoven E, Arat S, Meyfroidt S, Joly J, Moons P, Verschueren P, Westhovens R, CareRA Study Group. Are illness perception and coping style associated with the delay between symptom onset and the first general practitioner consultation in early rheumatoid arthritis management? An exploratory study within the CareRA trial. Scand J Rheumatol. 2016;45(3):171-8. doi: 10.3109/03009742.2015.1074278. Epub 2015 Sep 23.
Verschueren P, Esselens G, Westhovens R. Predictors of remission, normalized physical function, and changes in the working situation during follow-up of patients with early rheumatoid arthritis: an observational study. Scand J Rheumatol. 2009 May-Jun;38(3):166-72. doi: 10.1080/03009740802484846.
Verschueren P, Westhovens R. The use of glucocorticoids in early rheumatoid arthritis. Rheumatology (Oxford). 2018 Aug 1;57(8):1316-1317. doi: 10.1093/rheumatology/kex271. No abstract available.
Verschueren P, De Cock D, Corluy L, Joos R, Langenaken C, Taelman V, Raeman F, Ravelingien I, Vandevyvere K, Lenaerts J, Geens E, Geusens P, Vanhoof J, Durnez A, Remans J, Vander Cruyssen B, Van Essche E, Sileghem A, De Brabanter G, Joly J, Meyfroidt S, Van der Elst K, Westhovens R. Effectiveness of methotrexate with step-down glucocorticoid remission induction (COBRA Slim) versus other intensive treatment strategies for early rheumatoid arthritis in a treat-to-target approach: 1-year results of CareRA, a randomised pragmatic open-label superiority trial. Ann Rheum Dis. 2017 Mar;76(3):511-520. doi: 10.1136/annrheumdis-2016-209212. Epub 2016 Jul 18.
De Cock D, Van der Elst K, Meyfroidt S, Verschueren P, Westhovens R. The optimal combination therapy for the treatment of early rheumatoid arthritis. Expert Opin Pharmacother. 2015;16(11):1615-25. doi: 10.1517/14656566.2015.1056735. Epub 2015 Jun 10.
Verschueren P, De Cock D, Corluy L, Joos R, Langenaken C, Taelman V, Raeman F, Ravelingien I, Vandevyvere K, Lenaerts J, Geens E, Geusens P, Vanhoof J, Durnez A, Remans J, Vander Cruyssen B, Van Essche E, Sileghem A, De Brabanter G, Joly J, Van der Elst K, Meyfroidt S, Westhovens R; CareRA study group. Patients lacking classical poor prognostic markers might also benefit from a step-down glucocorticoid bridging scheme in early rheumatoid arthritis: week 16 results from the randomized multicenter CareRA trial. Arthritis Res Ther. 2015 Apr 9;17(1):97. doi: 10.1186/s13075-015-0611-8.
Meyfroidt S, Van der Elst K, De Cock D, Joly J, Westhovens R, Hulscher M, Verschueren P. Patient experiences with intensive combination-treatment strategies with glucocorticoids for early rheumatoid arthritis. Patient Educ Couns. 2015 Mar;98(3):384-90. doi: 10.1016/j.pec.2014.11.011. Epub 2014 Nov 20.
Verschueren P, De Cock D, Corluy L, Joos R, Langenaken C, Taelman V, Raeman F, Ravelingien I, Vandevyvere K, Lenaerts J, Geens E, Geusens P, Vanhoof J, Durnez A, Remans J, Vander Cruyssen B, Van Essche E, Sileghem A, De Brabanter G, Joly J, Meyfroidt S, Van der Elst K, Westhovens R. Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial. Ann Rheum Dis. 2015 Jan;74(1):27-34. doi: 10.1136/annrheumdis-2014-205489. Epub 2014 Oct 30.
Meyfroidt S, van Hulst L, De Cock D, Van der Elst K, Joly J, Westhovens R, Hulscher M, Verschueren P. Factors influencing the prescription of intensive combination treatment strategies for early rheumatoid arthritis. Scand J Rheumatol. 2014;43(4):265-72. doi: 10.3109/03009742.2013.863382. Epub 2014 Feb 24.
Westhovens R, Verschueren P. Rheumatoid arthritis: defining remission in patients with RA in clinical practice. Nat Rev Rheumatol. 2012 Aug;8(8):445-7. doi: 10.1038/nrrheum.2012.111. Epub 2012 Jul 3. No abstract available.
Verschueren P, Westhovens R. Optimal care for early RA patients: the challenge of translating scientific data into clinical practice. Rheumatology (Oxford). 2011 Jul;50(7):1194-200. doi: 10.1093/rheumatology/ker131. Epub 2011 Mar 30.
Durez P, Malghem J, Nzeusseu Toukap A, Depresseux G, Lauwerys BR, Westhovens R, Luyten FP, Corluy L, Houssiau FA, Verschueren P. Treatment of early rheumatoid arthritis: a randomized magnetic resonance imaging study comparing the effects of methotrexate alone, methotrexate in combination with infliximab, and methotrexate in combination with intravenous pulse methylprednisolone. Arthritis Rheum. 2007 Dec;56(12):3919-27. doi: 10.1002/art.23055.
Boers M, Verhoeven AC, Markusse HM, van de Laar MA, Westhovens R, van Denderen JC, van Zeben D, Dijkmans BA, Peeters AJ, Jacobs P, van den Brink HR, Schouten HJ, van der Heijde DM, Boonen A, van der Linden S. Randomised comparison of combined step-down prednisolone, methotrexate and sulphasalazine with sulphasalazine alone in early rheumatoid arthritis. Lancet. 1997 Aug 2;350(9074):309-18. doi: 10.1016/S0140-6736(97)01300-7.
Bertrand D, Joly J, Neerinckx B, Durez P, Lenaerts J, Joos R, Thevissen K, Zwaenepoel T, Vanhoof J, Di Romana S, Taelman V, Van Essche E, Corluy L, Ribbens C, Vanden Berghe M, Devinck M, Ajeganova S, Durnez A, Boutsen Y, Margaux J, Peene I, Van Offel J, Doumen M, Pazmino S, De Meyst E, Kulyk M, Creten N, Westhovens R, Verschueren P; CareRA2020 Study group. Effectiveness of methotrexate and bridging glucocorticoids with or without early introduction of a 6-month course of etanercept in early RA: results of the 2-year, pragmatic, randomised CareRA2020 trial. RMD Open. 2024 Aug 7;10(3):e004535. doi: 10.1136/rmdopen-2024-004535.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-004054-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
KCE-16002
Identifier Type: -
Identifier Source: org_study_id
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