Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405275
Status:
COMPLETED
Last Update Posted:
2013-12-03
First Post:
2006-11-29
Brief Title:
Rheumatoid Arthritis Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 551 - Rheumatoid Arthritis Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RACAT
Brief Summary:
Rheumatoid arthritis RA is a chronic inflammatory disease of the joints leading to joint destruction with significant long-term morbidity and mortality Early treatment of RA patients with disease-modifying antirheumatic drugs DMARDs significantly decreases these complications Methotrexate MTX is an excellent economical first-line DMARD used to treat a majority of RA patients While most patients respond well to MTX many continue to have active disease Therefore understanding how to best treat RA patients with active disease despite MTX therapy is critically important Although a number of therapies with significantly different economic implications have been shown to be effective when added to MTX no trial has directly compared active therapies This study will compare therapeutic strategies using two regimens with proven efficacy when added to MTX therapy a hydroxychloroquine and sulfasalazine cost 1000 per year b the tumor necrosis factor inhibitor etanercept cost 12000 per year
We propose a bi-national multi-center randomized double-blind equivalency trial comparing A the strategy of initially adding hydroxychloroquine and sulfasalazine to MTX in patients with active disease despite MTX with a switch at 24 weeks to etanercept in nonresponders to B a strategy of adding etanercept to MTX with a switch to hydroxychloroquine and sulfasalazine in nonresponders at 24 weeks If we find that the strategy of first adding hydroxychloroquine and sulfasalazine to MTX identifies a subset of responsive patients and that there is no harm to nonresponders because of early rescue with etanercept then this less expensive option should become the standard treatment for MTX resistant patients
Four hundred and fifty RA patients with active disease despite treatment with MTX as indicated by a Disease Activity Score with 28 joints DAS28 of 44 units will be randomized A DAS improvement of 12 validated as clinically significant at 24 weeks will be used to identify early nonresponder who will switch therapy Subjects with a DAS28 improvement of 12 at 24 weeks will remain on their initial therapy The primary endpoint is the change of DAS 28 scores from baseline to 48 weeks The secondary endpoint is comparison of radiographic progression of disease at 48 weeks as measured by the change in Sharp score Economic and functional outcomes will be assessed and a serum and DNA bank will be established to evaluate potential biomarkers predictive of treatment responsetoxicity and disease progression This trial will recruit 450 subjects over 40 months At the end of the 48 week blinded active therapy portion of the trial the blind will be broken and data will be collected in an open fashion until all 450 patients have completed the 48 week portion of the trial
We propose a bi-national multi-center randomized double-blind equivalency trial comparing A the strategy of initially adding hydroxychloroquine and sulfasalazine to MTX in patients with active disease despite MTX with a switch at 24 weeks to etanercept in nonresponders to B a strategy of adding etanercept to MTX with a switch to hydroxychloroquine and sulfasalazine in nonresponders at 24 weeks If we find that the strategy of first adding hydroxychloroquine and sulfasalazine to MTX identifies a subset of responsive patients and that there is no harm to nonresponders because of early rescue with etanercept then this less expensive option should become the standard treatment for MTX resistant patients
Four hundred and fifty RA patients with active disease despite treatment with MTX as indicated by a Disease Activity Score with 28 joints DAS28 of 44 units will be randomized A DAS improvement of 12 validated as clinically significant at 24 weeks will be used to identify early nonresponder who will switch therapy Subjects with a DAS28 improvement of 12 at 24 weeks will remain on their initial therapy The primary endpoint is the change of DAS 28 scores from baseline to 48 weeks The secondary endpoint is comparison of radiographic progression of disease at 48 weeks as measured by the change in Sharp score Economic and functional outcomes will be assessed and a serum and DNA bank will be established to evaluate potential biomarkers predictive of treatment responsetoxicity and disease progression This trial will recruit 450 subjects over 40 months At the end of the 48 week blinded active therapy portion of the trial the blind will be broken and data will be collected in an open fashion until all 450 patients have completed the 48 week portion of the trial
Detailed Description:
The main objective of this proposal is to compare two successful treatment strategies that have significantly different economic implications head-to-head in patients with rheumatoid arthritis who have active disease despite methotrexate therapy
Rheumatoid arthritis RA is a chronic inflammatory disease of the joints leading to joint destruction with significant long-term morbidity and mortality Early treatment of RA patients with disease-modifying antirheumatic drugs DMARDs significantly decreases these complications Methotrexate MTX is an excellent economical first-line DMARD used to treat a majority of RA patients While most patients respond well to MTX many continue to have active disease Therefore understanding how to best treat RA patients with active disease despite MTX therapy is critically important Although a number of therapies with significantly different economic implications have been shown to be effective when added to MTX no trial has directly compared active therapies This study will compare therapeutic strategies using two regimens with proven efficacy when added to MTX therapy a hydroxychloroquine and sulfasalazine cost 1000 per year b the tumor necrosis factor inhibitor etanercept cost 12000 per year
We propose a bi-national multi-center randomized double-blind equivalency trial comparing A the strategy of initially adding hydroxychloroquine and sulfasalazine to MTX in patients with active disease despite MTX with a switch at 24 weeks to etanercept in nonresponders to B a strategy of adding etanercept to MTX with a switch to hydroxychloroquine and sulfasalazine in nonresponders at 24 weeks If we find that the strategy of first adding hydroxychloroquine and sulfasalazine to MTX identifies a subset of responsive patients and that there is no harm to nonresponders because of early rescue with etanercept then this less expensive option should become the standard treatment for MTX resistant patients
Four hundred and fifty RA patients with active disease despite treatment with MTX as indicated by a Disease Activity Score with 28 joints DAS28 of greater than or equal to 44 units will be randomized A DAS improvement of greater than or equal to 12 validated as clinically significant at 24 weeks will be used to identify early nonresponder who will switch therapy Subjects with a DAS28 improvement of 12 at 24 weeks will remain on their initial therapy The primary endpoint is the change of DAS 28 scores from baseline to 48 weeks The secondary endpoint is comparison of radiographic progression of disease at 48 weeks as measured by the change in Sharp score Economic and functional outcomes will be assessed and a serum and DNA bank will be established to evaluate potential biomarkers predictive of treatment responsetoxicity and disease progression This trial will recruit 450 subjects over 40 months At the end of the 48 week blinded active therapy portion of the trial the blind will be broken and data will be collected in an open fashion until all 450 patients have completed the 48 week portion of the trial
Rheumatoid arthritis RA is a chronic inflammatory disease of the joints leading to joint destruction with significant long-term morbidity and mortality Early treatment of RA patients with disease-modifying antirheumatic drugs DMARDs significantly decreases these complications Methotrexate MTX is an excellent economical first-line DMARD used to treat a majority of RA patients While most patients respond well to MTX many continue to have active disease Therefore understanding how to best treat RA patients with active disease despite MTX therapy is critically important Although a number of therapies with significantly different economic implications have been shown to be effective when added to MTX no trial has directly compared active therapies This study will compare therapeutic strategies using two regimens with proven efficacy when added to MTX therapy a hydroxychloroquine and sulfasalazine cost 1000 per year b the tumor necrosis factor inhibitor etanercept cost 12000 per year
We propose a bi-national multi-center randomized double-blind equivalency trial comparing A the strategy of initially adding hydroxychloroquine and sulfasalazine to MTX in patients with active disease despite MTX with a switch at 24 weeks to etanercept in nonresponders to B a strategy of adding etanercept to MTX with a switch to hydroxychloroquine and sulfasalazine in nonresponders at 24 weeks If we find that the strategy of first adding hydroxychloroquine and sulfasalazine to MTX identifies a subset of responsive patients and that there is no harm to nonresponders because of early rescue with etanercept then this less expensive option should become the standard treatment for MTX resistant patients
Four hundred and fifty RA patients with active disease despite treatment with MTX as indicated by a Disease Activity Score with 28 joints DAS28 of greater than or equal to 44 units will be randomized A DAS improvement of greater than or equal to 12 validated as clinically significant at 24 weeks will be used to identify early nonresponder who will switch therapy Subjects with a DAS28 improvement of 12 at 24 weeks will remain on their initial therapy The primary endpoint is the change of DAS 28 scores from baseline to 48 weeks The secondary endpoint is comparison of radiographic progression of disease at 48 weeks as measured by the change in Sharp score Economic and functional outcomes will be assessed and a serum and DNA bank will be established to evaluate potential biomarkers predictive of treatment responsetoxicity and disease progression This trial will recruit 450 subjects over 40 months At the end of the 48 week blinded active therapy portion of the trial the blind will be broken and data will be collected in an open fashion until all 450 patients have completed the 48 week portion of the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Y1-AR-0048-01 | OTHER | Inter Agency Agreement between NIAMS and DVA | None |