Very Early Versus Delayed Etanercept in Patients With RA (VEDERA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02433184|
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Etanercept Drug: Methotrexate Drug: Sulfasalazine Drug: Hydroxychloroquine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early Versus Delayed Etanercept in Patients With Rheumatoid Arthritis|
|Actual Study Start Date :||July 2011|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||July 2019|
Treatment Arm 1 will receive etanercept and methotrexate combination therapy administered for a total duration of 48 weeks.
Etanercept will be administered subcutaneously at a dose of 50 mg weekly and will be discontinued at the primary endpoint (48 weeks).
Methotrexate will be administered orally at a starting dose of 15 mg weekly, increasing to 20mg and 25mg weekly at weeks 4 and 8 respectively.
Active Comparator: Methotrexate-treat to target
Treatment Arm 2 will receive initial methotrexate monotherapy with adoption of a treat to target protocol (standard care involving monthly DAS28-ESR assessment with escalation to combination sDMARD therapy if not achieving LDA at, or after, 8 weeks) and step-up to etanercept and methotrexate at 24 weeks if failing to achieve clinical remission
Methotrexate will be administered orally at a starting dose of 15 mg and will be increased to 25mg weekly at 2 weeks.
Sulfasalazine will be added at weeks 8,12,16 or 20 if the subject fails to achieve low disease activity, administered orally at a dose of 1g twice daily. Will be discontinued if starting etanercept at 24 weeks.
Hydroxychloroquine will be added at weeks 8,12,16 or 20 if the subject fails to achieve low disease activity, administered at a dose of 200mg daily. Will be discontinued if starting etanercept at 24 weeks.
Etanercept will be added at 24 weeks, if a subject fails to achieve clinical remission,at a dose of 50 mg weekly and will be discontinued at 48 weeks with the exception of those patients who are eligible to continue according to local prescribing guidelines (NICE guidelines)
- Clinical remission [ Time Frame: 48 weeks ]Proportion of patients that achieve clinical remission (Disease activity Score, DAS28 <2.6) at 48 weeks, following either treatment strategy.
- Change in MRI synovitis [ Time Frame: baseline and week 48 ]Change in MRI synovitis between baseline and 48 weeks.
- CDAI (clinical disease activity index) [ Time Frame: weeks 12, 24, 48 and 96 ]Change in CDAI score from baseline at weeks 12, 24, 48 and 96
- SDAI (simplified disease activity index) [ Time Frame: weeks 12, 24, 48 and 96 ]Change in SDAI score from baseline at weeks 12, 24, 36 & 48.
- ACR(American College of Rheumatology) response scores [ Time Frame: weeks 12, 24, 48 and 96 ]ACR response score from baseline at weeks 12, 24, 48 and 96
- EULAR(European League Against Rheumatism)response criteria [ Time Frame: weeks 12, 24, 48 and 96 ]EULAR response score from baseline
- Physical function, assessed by HAQ(health assessment questionnaire) [ Time Frame: weeks 12, 24, 48 and 96 ]
- Quality of life scores assessed by RA-QoL(RA quality of life questionnaire) [ Time Frame: weeks 12, 24, 48 and 96 ]
- Work instability, assessed by RA-WIS(RA work instability questionnaire) [ Time Frame: weeks 12, 24, 48 and 96 ]
- HRUS (High Resolution Ultrasound) [ Time Frame: weeks 0, 12, 24 and 48 ]Change in HRUS from baseline
- Radiographic scores [ Time Frame: weeks 48 and 96 ]Change in joint damage assessed by modified Sharp score.
- Immunological parameters in blood sample [ Time Frame: weeks 0, 12, 24 and 48 ]Change in immunological markers of inflammation between baseline and weeks 12, 24 and 48.
- Immunological parameters in synovial tissue [ Time Frame: weeks 0, 24, +/- 48 ]Change in immunological markers of inflammation between baseline and weeks 24 and 48.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433184
|Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital|
|Leeds, West Yorkshire, United Kingdom, LS7 4SA|