Systematic SclerosisGRegistry SCDUNCT02798055
Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis
An observational study of Systematic Sclerosis and Digital Ulcer, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial summary
GRegistry is a significant collection of data and information on the clinical practice of systemic scleroderma finger ulcers. The GRegistry study is a nationwide (Greece) prospective study recording, which includes consecutive patients with SC-DU diagnosis in clinical management departments of different hospitals… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systematic Sclerosis, Digital Ulcer, Scleroderma
- What is being tested?
- Bosentan group
- How many people
- 148 participants
- Where
- 1 siteGreece
- Study dates
- 30 Sep 2016to 30 Jun 2019
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Digital Ulcers caused by Systematic Scleroderma according to ACR 2013 criteria
Who may be able to join
- Both genders >18 and < 80 years
- ACR 2013 criteria >9 \& =9
- At least one Digital Ulcer
- Raynaud Severity Scale (0-10)
Who cannot join
- < 18 years
- ACR 2013 criteria <9
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment.
GRegistry is a significant collection of data and information on the clinical practice of systemic scleroderma finger ulcers.
The GRegistry study is a nationwide (Greece) prospective study recording, which includes consecutive patients with SC-DU diagnosis in clinical management departments of different hospitals, selected in such a way as to reflect a representation of the country.
The use of Bosentan in the treatment of patients suffering from systemic sclerosis with digital ulcer disease is supported by data from large, placebo-controlled, randomized studies. The beneficial effect of Bosentan in digital ulcers, a vascular event of systemic sclerosis consistent with its beneficial effect on pulmonary arterial hypertension associated with connective tissue disease and its beneficial effect on vascular remodeling.
Read the detailed description
The existence and use of Patient Registries, represents one of the foundations of the progressing medical science, both for studying the natural history of diseases as well as to critically evaluate the therapeutic methods, the collection and analysis of the data from a large number of hospital units, is essential. Furthermore, the assessment of the effectiveness and adequacy of health services should be based on long-term monitoring of large groups of patients, and the assessment of the efficient functioning of the individual units, is only possible only with the availability of information for the patients of these units.
Moreover, the record of health services distribution data is a prerequisite for the design of their future development. The above led to growth of many national and international patient logs, diseases and specific treatments, the operation of which has contributed to the advancement of medical science.
Scleroderma or Systemic Sclerosis (SC) is a chronic autoimmune disease of the connective tissue with an incidence of 1: 10000- 1: 30000. In Greece it is estimated that there are approximately 2,500 patients. The disease usually affects women aged 40-60 years, and the incidence is four women to one man. The pathogenesis of the disease is unknown, while the main causes are considered genetic and environmental factors.
Two of the most critical complications of the disease, are the Pulmonary Arterial Hypertension, which occurs in patients with SC approximately 8-12% of patients, being the main cause of death, and digital ulcers that occur in 30-60 % of patients and are painful sores on the fingers. Digital ulcers, i.e. painful sores on the fingers, as a consequence of the limited blood supply of vessels are seen in approximately 30-60 % of patients with scleroderma. The digital ulcers adversely affect the quality of life of patients, even the simple daily activities and can lead to serious complications, such as amputation. The symptoms of scleroderma can vary between patients and may not be typical of this disease, at least in the early stages, making it difficult to diagnose. Two of the early symptoms are disturbance of blood supply to the extremities by a color change of the skin of the fingers, alternately pallor-cyanation-redness (Raynaud phenomenon) and rigid edematous fingers.
- Conditions
- Systematic Sclerosis, Digital Ulcer, Scleroderma
- Being tested
- Bosentan group
- Medical subject headings
- digital ulcers, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bosentan groupDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reynaud Severity Scale
Measured: 4 months
Number of Ulcers
Measured: 4 months
Modified Rodnan Skin Score - MRSS
Measured: 4 months
Complications of systems
Number of organic systems which are affected by Systematic Scleroderma within last 4 months
Measured: 4 months
Secondary outcomes (1)
Adverse Events
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start30 Sep 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systematic SclerosisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798055
- Sponsor's protocol ID
- 2016-BSN-EL-64
- Acronym
- GRegistry SCDU
- Status last verified
- Dec 2018
- First submitted
- 3 Jun 2016
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Observational, Multi-center Registry to Examine the Characteristics of Patients With Systematic Sclerosis Digital Ulcers and Assess Bosentan Treatment.
- ClinicalTrials.gov ID
- NCT02798055
- Acronym / sponsor ID
- GRegistry SCDU / 2016-BSN-EL-64
- Conditions
- Systematic Sclerosis, Digital Ulcer, Scleroderma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 14 Jun 2016 (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.
GRegistry is a significant collection of data and information on the clinical practice of systemic scleroderma finger ulcers.
The GRegistry study is a nationwide (Greece) prospective study recording, which includes consecutive patients with SC-DU diagnosis in clinical management departments of different hospitals, selected in such a way as to reflect a representation of the country.
The use of Bosentan in the treatment of patients suffering from systemic sclerosis with digital ulcer disease is supported by data from large, placebo-controlled, randomized studies. The beneficial effect of Bosentan in digital ulcers, a vascular event of systemic sclerosis consistent with its beneficial effect on pulmonary arterial hypertension associated with connective tissue disease and its beneficial effect on vascular remodeling.
Detailed description
The existence and use of Patient Registries, represents one of the foundations of the progressing medical science, both for studying the natural history of diseases as well as to critically evaluate the therapeutic methods, the collection and analysis of the data from a large number of hospital units, is essential. Furthermore, the assessment of the effectiveness and adequacy of health services should be based on long-term monitoring of large groups of patients, and the assessment of the efficient functioning of the individual units, is only possible only with the availability of information for the patients of these units.
Moreover, the record of health services distribution data is a prerequisite for the design of their future development. The above led to growth of many national and international patient logs, diseases and specific treatments, the operation of which has contributed to the advancement of medical science.
Scleroderma or Systemic Sclerosis (SC) is a chronic autoimmune disease of the connective tissue with an incidence of 1: 10000- 1: 30000. In Greece it is estimated that there are approximately 2,500 patients. The disease usually affects women aged 40-60 years, and the incidence is four women to one man. The pathogenesis of the disease is unknown, while the main causes are considered genetic and environmental factors.
Two of the most critical complications of the disease, are the Pulmonary Arterial Hypertension, which occurs in patients with SC approximately 8-12% of patients, being the main cause of death, and digital ulcers that occur in 30-60 % of patients and are painful sores on the fingers. Digital ulcers, i.e. painful sores on the fingers, as a consequence of the limited blood supply of vessels are seen in approximately 30-60 % of patients with scleroderma. The digital ulcers adversely affect the quality of life of patients, even the simple daily activities and can lead to serious complications, such as amputation. The symptoms of scleroderma can vary between patients and may not be typical of this disease, at least in the early stages, making it difficult to diagnose. Two of the early symptoms are disturbance of blood supply to the extremities by a color change of the skin of the fingers, alternately pallor-cyanation-redness (Raynaud phenomenon) and rigid edematous fingers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Digital Ulcers caused by Systematic Scleroderma according to ACR 2013 criteria
Key inclusion criteria (4 listed)
- Both genders >18 and < 80 years
- ACR 2013 criteria >9 \& =9
- At least one Digital Ulcer
- Raynaud Severity Scale (0-10)
Key exclusion criteria (2 listed)
- < 18 years
- ACR 2013 criteria <9
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 group | Drug | – |
Primary outcome
Reynaud Severity Scale
Time frame: 4 months
Number of Ulcers
Time frame: 4 months
Modified Rodnan Skin Score - MRSS
Time frame: 4 months
Complications of systems
Time frame: 4 months
Number of organic systems which are affected by Systematic Scleroderma within last 4 months
1 secondary outcome
Adverse Events
Time frame: 4 months
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 5 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systematic Sclerosis and Digital Ulcer, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Reynaud Severity Scale (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2019.