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In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bosentan | Experimental | The patients received bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks and then 125 mg b.i.d. for 20 weeks |
|
| Placebo | Placebo Comparator | The patients received the matching placebo for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosentan 62.5 mg | Drug | Oral tablets containing 62.5 mg of bosentan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks | 24 weeks | |
| Total number of new digital ulcers per patient up to Week 24 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 24 in hand pain | Pain assessed on visual analog scales | Baseline and Week 24 |
| Change from baseline to Week 24 in hand disability | Hand disability indexed assessed using the Health Assessment Questionaire (HAQ) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Seibold, MD | Robert Wood Johnson Medical School, New Brunswick, NJ, USA | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20805294 | Result | Matucci-Cerinic M, Denton CP, Furst DE, Mayes MD, Hsu VM, Carpentier P, Wigley FM, Black CM, Fessler BJ, Merkel PA, Pope JE, Sweiss NJ, Doyle MK, Hellmich B, Medsger TA Jr, Morganti A, Kramer F, Korn JH, Seibold JR. Bosentan treatment of digital ulcers related to systemic sclerosis: results from the RAPIDS-2 randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2011 Jan;70(1):32-8. doi: 10.1136/ard.2010.130658. Epub 2010 Aug 30. | |
| 33765691 |
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| ID | Term |
|---|---|
| C000721267 | digital ulcers |
| D012595 | Scleroderma, Systemic |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077300 | Bosentan |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Bosentan 125 mg | Drug | Oral tablets containing 125 mg of bosentan |
|
|
| Placebo | Drug | Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets |
|
| Baseline and Week 24 |
| Proportion of subjects with treatment-emergent adverse events | up to 32 weeks (8 week post-treatment follow-up) |
| Proportion of subjects with liver function abnormalities | Increase in aminotransferases | Every 4 weeks up to Week 24 |
| Derived |
| Liu C, Chen J, Gao Y, Deng B, Liu K. Endothelin receptor antagonists for pulmonary arterial hypertension. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD004434. doi: 10.1002/14651858.CD004434.pub6. |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |