NCT02798055

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 30, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 5, 2019

Status Verified

December 1, 2018

Enrollment Period

2.7 years

First QC Date

June 3, 2016

Last Update Submit

July 2, 2019

Conditions

Systematic SclerosisDigital UlcerScleroderma

Outcome Measures

Primary Outcomes (4)

  • Reynaud Severity Scale

    4 months

  • Number of Ulcers

    4 months

  • Modified Rodnan Skin Score - MRSS

    4 months

  • Complications of systems

    Number of organic systems which are affected by Systematic Scleroderma within last 4 months

    4 months

Secondary Outcomes (1)

  • Adverse Events

    4 months

Interventions

Bosentan groupDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Digital Ulcers caused by Systematic Scleroderma according to ACR 2013 criteria

You may qualify if:

  • Both genders \>18 and \< 80 years
  • ACR 2013 criteria \>9 \& =9
  • At least one Digital Ulcer
  • Raynaud Severity Scale (0-10)

You may not qualify if:

  • \< 18 years
  • ACR 2013 criteria \<9

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic, Laiko Hospital

Athens, Greece

Location

MeSH Terms

Conditions

digital ulcersScleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 14, 2016

Study Start

September 30, 2016

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 5, 2019

Record last verified: 2018-12

Locations

GR(1)