Digital UlcersPhase 3RAPIDS-2NCT00077584
Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma
A Phase 3 study testing Bosentan 62.5 mg and Bosentan 125 mg in people with Digital Ulcers and Systemic Sclerosis, run by Actelion.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digital Ulcers, Systemic Sclerosis
- What is being tested?
- Bosentan 62.5 mg and Bosentan 125 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to May 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Systemic Sclerosis (SSc), diffuse or limited.
- SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer.
Main Exclusion Criteria:
- Digital ulcers due to conditions other than SSc.
- Severe pulmonary arterial hypertension (PAH) (Who class III and IV).
- Malabsorption or any severe organ failure (e.g., lung, kidney, liver) or any life-threatening condition.
- Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, or prostacyclin analogs) during the past 3 months prior to randomization.
- Treatment with inhaled or oral prostanoids one month prior to randomization.
- Previous treatment with bosentan.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis
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.
- Conditions
- Digital Ulcers, Systemic Sclerosis
- Being tested
- Bosentan 62.5 mg, Bosentan 125 mg, Placebo
- Keywords
- Scleroderma, Finger Ulcers, Digital Ulcers, Systemic Sclerosis
- Medical subject headings
- digital ulcers, Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bosentan 62.5 mgDrug
Also called Ro 47-0203
Oral tablets containing 62.5 mg of bosentan
Bosentan 125 mgDrug
Also called Ro 47-0203
Oral tablets containing 125 mg of bosentan
PlaceboDrug
Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Bosentan 62.5 mg; Drug: Bosentan 125 mg |
| Placebo | Placebo comparator | The patients received the matching placebo for 24 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks
Measured: 24 weeks
Total number of new digital ulcers per patient up to Week 24
Measured: 24 weeks
Secondary outcomes (4)
Change from baseline to Week 24 in hand pain
Pain assessed on visual analog scales
Measured: Baseline and Week 24
Change from baseline to Week 24 in hand disability
Hand disability indexed assessed using the Health Assessment Questionaire (HAQ)
Measured: Baseline and Week 24
Proportion of subjects with treatment-emergent adverse events
Measured: up to 32 weeks (8 week post-treatment follow-up)
Proportion of subjects with liver function abnormalities
Increase in aminotransferases
Measured: Every 4 weeks up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2004 (estimated)
- Study startOct 2003
- Primary completionMar 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Digital UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Seibold, MD, Principal investigator, Robert Wood Johnson Medical School, New Brunswick, NJ, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077584
- Sponsor's protocol ID
- AC-052-331
- Acronym
- RAPIDS-2
- Status last verified
- Jan 2025
- First submitted
- 10 Feb 2004
- Last updated
- 3 Feb 2025
- Results posted
- No
Publications
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.
PubMed 20805294Liu 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.
PubMed 33765691
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT00077584
- Acronym / sponsor ID
- RAPIDS-2 / AC-052-331
- Conditions
- Digital Ulcers, Systemic Sclerosis
- Keywords
- Scleroderma, Finger Ulcers, Digital Ulcers, Systemic Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Mar 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 11 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bosentan | Experimental | Drug: Bosentan 62.5 mg, Drug: Bosentan 125 mgThe 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 | Drug: PlaceboThe patients received the matching placebo for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bosentan 62.5 mgAlso: Ro 47-0203Oral tablets containing 62.5 mg of bosentan | Drug | Bosentan |
| Bosentan 125 mgAlso: Ro 47-0203Oral tablets containing 125 mg of bosentan | Drug | Bosentan |
| PlaceboOral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets | Drug | Placebo |
Primary outcome
Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks
Time frame: 24 weeks
Total number of new digital ulcers per patient up to Week 24
Time frame: 24 weeks
4 secondary outcomes
Change from baseline to Week 24 in hand pain
Time frame: Baseline and Week 24
Change from baseline to Week 24 in hand disability
Time frame: Baseline and Week 24
Proportion of subjects with treatment-emergent adverse events
Time frame: up to 32 weeks (8 week post-treatment follow-up)
Proportion of subjects with liver function abnormalities
Time frame: Every 4 weeks up to Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Results publication: PubMed 20805294Matucci-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.
- Derived from this study: PubMed 33765691Liu 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.
Related trials for Digital Ulcers
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
RecruitingObservational study
Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study
Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
Active, not recruiting
A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome
Irritable Bowel Syndrome, Inflammatory Bowel Diseases
RecruitingPhase 2
Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis
Digital Ulcers in Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Seibold, MD principal investigator
Robert Wood Johnson Medical School, New Brunswick, NJ, USA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bosentan 62.5 mg and Bosentan 125 mg in people with Digital Ulcers and Systemic Sclerosis, run by Actelion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00077584, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.