Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
Information source: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: randomisation (Other)
Phase: Phase 4
Status: Completed
Sponsored by: P. Verschueren Official(s) and/or principal investigator(s): Patrick Verschueren, MD, PhD, Principal Investigator, Affiliation: Universitaire Ziekenhuizen Leuven
Summary
The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the
development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study
introduced the principle of fast remission induction by means of a combination of standard
Disease Modifying AntiRheumatic Drugs (DMARDs) and a step down bridge therapy with high dose
glucocorticoids in early Rheumatoid Arthritis.
The purpose of the present study is to compare different combinations of traditional DMARDs
and glucocorticoids, based on the original CoBRA protocol, for treatment of early Rheumatoid
Arthritis.
Besides the efficacy and effectiveness of these strategies, patient centered outcomes and
potential implementation problems of such treatment strategies are evaluated.
Clinical Details
Official title: A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: remissionremission remission
Secondary outcome: efficacyeffectiveness safety efficacy efficacy efficacy effectiveness effectiveness
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of RA as defined by the 1987 revised American College of Rheumatology (ACR)
criteria
- Early RA (less than 1 year)
- Use a reliable method of contraception for women of childbearing potential
- Able and willing to give written informed consent and participate in the study
Exclusion Criteria:
- Previous treatment with DMARDs
- Previous treatment with oral corticosteroids at a dosage of more than 10 milligrams
(mg) prednisone within 4 weeks before baseline
- Previous treatment with oral corticosteroids at a dosage equal to or less than 10 mg
prednisone within 2 weeks before baseline
- Previous treatment with oral corticosteroids for more than 4 weeks
- Previous treatment with Intra Articular corticosteroids within 4 weeks before
baseline
- Previous treatment with an investigational drug for the treatment or prevention of RA
- Contraindications for corticosteroids
- Contraindications for DMARDs
- 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
- Alcohol or drug abuse
Locations and Contacts
ASZ, Aalst 9300, Belgium
OLV Ziekenhuis, Aalst 9300, Belgium
Imelda Ziekenhuis, Bonheiden 2820, Belgium
AZ St Lucas, Brugge 8310, Belgium
Reuma praktijk, Genk 3600, Belgium
Reumacentrum, Genk 3600, Belgium
UZ Gent, dept. of Rheumatology, Gent 9000, Belgium
Reuma instituut Hasselt, Hasselt 3500, Belgium
Reumapraktijk, Hasselt 3500, Belgium
Jan Yperman Ziekenhuis, Ieper 8900, Belgium
AZ groeninge, Kortrijk 8500, Belgium
HHart Ziekenhuis, Leuven 3000, Belgium
MCH, Leuven 3000, Belgium
Universitaire Ziekenhuizen Leuven, Leuven 3000, Belgium
AZ St maarten, Mechelen 2800, Belgium
ZNA Jan Palfijn, Merksem 2170, Belgium
Henri Serruys ziekenhuis, Oostende 8400, Belgium
Additional Information
Related publications: 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, Esselens G, Westhovens R. Daily practice effectiveness of a step-down treatment in comparison with a tight step-up for early rheumatoid arthritis. Rheumatology (Oxford). 2008 Jan;47(1):59-64. Epub 2007 Nov 26. 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. Esselens G, Westhovens R, Verschueren P. Effectiveness of an integrated outpatient care programme compared with present-day standard care in early rheumatoid arthritis. Musculoskeletal Care. 2009 Mar;7(1):1-16. doi: 10.1002/msc.136. 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. Erratum in: Lancet 1998 Jan 17;351(9097):220.
Starting date: February 2009
Last updated: June 9, 2015
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