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Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Methotrexate
Sulfasalazine
Leflunomide
Prednisone
Sponsored by
P. Verschueren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring CoBRA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of RA as defined by the 1987 or 2010 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

Sites / Locations

  • ASZ
  • OLV Ziekenhuis
  • Imelda Ziekenhuis
  • AZ St Lucas
  • Reuma praktijk
  • Reumacentrum
  • UZ Gent, dept. of Rheumatology
  • Reuma instituut Hasselt
  • Reumapraktijk
  • Jan Yperman Ziekenhuis
  • AZ groeninge
  • HHart Ziekenhuis
  • MCH
  • Universitaire Ziekenhuizen Leuven
  • AZ St maarten
  • ZNA Jan Palfijn
  • Henri Serruys ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

CoBRA classic high risk group

CoBRA slim high risk group

CoBRA avant-garde high risk group

CoBRA slim low risk group

Tight Step Up low risk group

Arm Description

Methotrexate 15mg tablet by mouth, weekly for entire trial Sulfasalazine 2g tablet by mouth, daily for 40 weeks Prednisone tablet by mouth, weekly step down scheme 60 - 40 - 25 - 20 - 15 - 10 mg daily for 6 weeks, followed by 7.5mg daily till week 28, then further tapered down to stop at week 32

Methotrexate 15mg tablet by mouth, weekly for entire trial Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32

Methotrexate 15mg tablet by mouth, weekly for 40 weeks (continued for entire trial if randomized to Methotrexate monotherapy at week 40) Leflunomide 10mg tablet by mouth, daily for 40 weeks (continued for entire trial if randomized to Leflunomide monotherapy at week 40) Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32

Methotrexate 15mg tablet by mouth, weekly for entire trial Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32

Methotrexate 15mg tablet by mouth, weekly for entire trial No oral steroids allowed during the first year of the trial

Outcomes

Primary Outcome Measures

Remission According to DAS28-CRP at Week 16
Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 16. DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Remission According to DAS28-CRP at Week 52
Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 52. (co-primary end point) DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Remission According to DAS28-CRP at Week 104
Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 104. (co-primary endpoints) DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.

Secondary Outcome Measures

Remission According to SDAI (Simple Disease Activity Index) at Week 16
Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 16. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Remission According to SDAI at Week 52
Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 52. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Remission According to SDAI at Week 104
Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 104. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Clinically Significant Change in HAQ Score
Number of patients with a change of > 0.22 in the Health Assessment Questionnaire (HAQ) score over the period between baseline and week 104. A change of > 0.22 in this score is considered as clinical relevant for rheumatoid arthritis patients.

Full Information

First Posted
July 28, 2010
Last Updated
January 8, 2019
Sponsor
P. Verschueren
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie
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1. Study Identification

Unique Protocol Identification Number
NCT01172639
Brief Title
Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
Official Title
A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
P. Verschueren
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
CoBRA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Before randomisation patients were stratified to a high-risk or low-risk group according to the presence of risk factors at screening (having erosions, rheumatoid factor and/or anticitrullinated protein antibody and a high disease activity score calculated with C-reactive protein (DAS28-CRP)). Randomisation to treatment arms was performed via a digitally generated sequence. Patients in the high-risk group were randomised into CoBRA Classic, Clim or Avant-Garde arm. Patients in the low-risk group were randomised into CoBRA Slim or Tight Step Up arm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CoBRA classic high risk group
Arm Type
Other
Arm Description
Methotrexate 15mg tablet by mouth, weekly for entire trial Sulfasalazine 2g tablet by mouth, daily for 40 weeks Prednisone tablet by mouth, weekly step down scheme 60 - 40 - 25 - 20 - 15 - 10 mg daily for 6 weeks, followed by 7.5mg daily till week 28, then further tapered down to stop at week 32
Arm Title
CoBRA slim high risk group
Arm Type
Other
Arm Description
Methotrexate 15mg tablet by mouth, weekly for entire trial Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32
Arm Title
CoBRA avant-garde high risk group
Arm Type
Other
Arm Description
Methotrexate 15mg tablet by mouth, weekly for 40 weeks (continued for entire trial if randomized to Methotrexate monotherapy at week 40) Leflunomide 10mg tablet by mouth, daily for 40 weeks (continued for entire trial if randomized to Leflunomide monotherapy at week 40) Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32
Arm Title
CoBRA slim low risk group
Arm Type
Other
Arm Description
Methotrexate 15mg tablet by mouth, weekly for entire trial Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32
Arm Title
Tight Step Up low risk group
Arm Type
Other
Arm Description
Methotrexate 15mg tablet by mouth, weekly for entire trial No oral steroids allowed during the first year of the trial
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Ledertrexate
Intervention Description
Methotrexate tablet
Intervention Type
Drug
Intervention Name(s)
Sulfasalazine
Other Intervention Name(s)
Salazopyrine
Intervention Description
Sulfasalazine tablet
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Other Intervention Name(s)
Arava
Intervention Description
Leflunomide tablet
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone tablet
Primary Outcome Measure Information:
Title
Remission According to DAS28-CRP at Week 16
Description
Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 16. DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Time Frame
week 16
Title
Remission According to DAS28-CRP at Week 52
Description
Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 52. (co-primary end point) DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Time Frame
week 52
Title
Remission According to DAS28-CRP at Week 104
Description
Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 104. (co-primary endpoints) DAS28-CRP is calculated with the following formula : 0.56*SQRT TJC28+0.28*SQRT SJC28+0.36*ln (CRP+1)+0.014*GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Time Frame
week 104
Secondary Outcome Measure Information:
Title
Remission According to SDAI (Simple Disease Activity Index) at Week 16
Description
Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 16. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Time Frame
week 16
Title
Remission According to SDAI at Week 52
Description
Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 52. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Time Frame
week 52
Title
Remission According to SDAI at Week 104
Description
Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 104. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Time Frame
week 104
Title
Clinically Significant Change in HAQ Score
Description
Number of patients with a change of > 0.22 in the Health Assessment Questionnaire (HAQ) score over the period between baseline and week 104. A change of > 0.22 in this score is considered as clinical relevant for rheumatoid arthritis patients.
Time Frame
Baseline-week104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of RA as defined by the 1987 or 2010 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Verschueren, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASZ
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
OLV Ziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ St Lucas
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
Reuma praktijk
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Reumacentrum
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
UZ Gent, dept. of Rheumatology
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Reuma instituut Hasselt
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Reumapraktijk
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Jan Yperman Ziekenhuis
City
Ieper
ZIP/Postal Code
8900
Country
Belgium
Facility Name
AZ groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
HHart Ziekenhuis
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
MCH
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ St maarten
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
ZNA Jan Palfijn
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Henri Serruys ziekenhuis
City
Oostende
ZIP/Postal Code
8400
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19169906
Citation
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.
Results Reference
background
PubMed Identifier
18039681
Citation
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. doi: 10.1093/rheumatology/kem288. Epub 2007 Nov 26.
Results Reference
background
PubMed Identifier
18050189
Citation
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.
Results Reference
background
PubMed Identifier
18618520
Citation
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.
Results Reference
background
PubMed Identifier
9251634
Citation
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. Erratum In: Lancet 1998 Jan 17;351(9097):220.
Results Reference
background
PubMed Identifier
26058860
Citation
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.
Results Reference
background
PubMed Identifier
25359382
Citation
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.
Results Reference
result
PubMed Identifier
25889222
Citation
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.
Results Reference
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PubMed Identifier
27432356
Citation
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.
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PubMed Identifier
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Citation
Pazmino S, Boonen A, De Cock D, Stouten V, Joly J, Bertrand D, Westhovens R, Verschueren P. Short-term glucocorticoids reduce risk of chronic NSAID and analgesic use in early methotrexate-treated rheumatoid arthritis patients with favourable prognosis: subanalysis of the CareRA randomised controlled trial. RMD Open. 2021 May;7(2):e001615. doi: 10.1136/rmdopen-2021-001615.
Results Reference
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PubMed Identifier
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Citation
Stouten V, Westhovens R, De Cock D, Van der Elst K, Pazmino S, Bertrand D, Joly J, Verschueren P. Having a co-morbidity predicts worse outcome in early rheumatoid arthritis despite intensive treatment: a post hoc evaluation of the pragmatic randomized controlled CareRA trial. Rheumatology (Oxford). 2021 Aug 2;60(8):3699-3708. doi: 10.1093/rheumatology/keaa841.
Results Reference
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PubMed Identifier
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Citation
Pazmino S, Lovik A, Boonen A, De Cock D, Stouten V, Joly J, Bertrand D, Van der Elst K, Westhovens R, Verschueren P. Does Including Pain, Fatigue, and Physical Function When Assessing Patients with Early Rheumatoid Arthritis Provide a Comprehensive Picture of Disease Burden? J Rheumatol. 2021 Feb;48(2):174-178. doi: 10.3899/jrheum.200758. Epub 2020 Nov 15.
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derived
PubMed Identifier
32241795
Citation
Pazmino S, Boonen A, Stouten V, De Cock D, Joly J, Van der Elst K, Westhovens R, Verschueren P. Two-year cost-effectiveness of different COBRA-like intensive remission induction schemes in early rheumatoid arthritis: a piggyback study on the pragmatic randomised controlled CareRA trial. Ann Rheum Dis. 2020 May;79(5):556-565. doi: 10.1136/annrheumdis-2019-216874. Epub 2020 Apr 2.
Results Reference
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PubMed Identifier
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Citation
Stouten V, Michiels S, Westhovens R, De Cock D, Belba A, Pazmino S, Van der Elst K, Joly J, Verschueren P. Effectiveness of maintenance therapy with methotrexate compared with leflunomide for patients with RA having achieved disease control with both these drugs: results of a predefined sub-analysis of CareRA, a pragmatic RCT. Clin Rheumatol. 2020 Sep;39(9):2593-2601. doi: 10.1007/s10067-020-05008-4. Epub 2020 Mar 12.
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Stouten V, Westhovens R, Pazmino S, De Cock D, Van der Elst K, Joly J, Verschueren P; CareRA study group. Effectiveness of different combinations of DMARDs and glucocorticoid bridging in early rheumatoid arthritis: two-year results of CareRA. Rheumatology (Oxford). 2019 Dec 1;58(12):2284-2294. doi: 10.1093/rheumatology/kez213.
Results Reference
derived

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Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

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