Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis

Early Diffuse Cutaneous Systemic Sclerosis Clinical Trial

— ESOS  

Official title:

Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339441
• Other study ID #: 10H101429
• Status: Completed
• Phase: N/A
• First received: December 22, 2014
• Last updated: May 12, 2016
• Start date: June 2010
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: ESOS Oversight Board
• Study type: Observational

Clinical Trial Summary

The aim of the study is to compare the effectiveness of commonly used immunosuppressant treatments for early diffuse cutaneous systemic sclerosis (SSc).

Description:

Diffuse cutaneous systemic sclerosis (SSc) is a rare autoimmune disease characterised by excessive connective tissue in the skin (causing skin thickening called 'scleroderma'), muscle, joints and internal organs. A number of different drugs with effects on the immune system (known as 'immunosuppressants') are currently being used by clinicians in the treatment of early diffuse cutaneous SSc, but all can have significant side effects. We want to know whether any one is definitely effective and, if so, which is the most effective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age > 18 Skin thickening < 3 years Immunosuppressant use < 4 months Proximal skin involvement to face/neck, elbow or knee

Exclusion Criteria:

Previous use of more than 4 months of methotrexate, mycophenolate mofetil, cyclophosphamide or other immunosuppressive treatments

Previous use of immunosuppressant therapy other than methotrexate, mycophenolate mofetil or cyclophosphamide within previous months

Previous stem cell transplantation therapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Early Diffuse Cutaneous Systemic Sclerosis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

Drug:
• Methotrexate
Immunosuppressant agent. Patients treated with Methotrexate at the entry of the study, either oral or subcutaneous with a target dose of 20-25mg weekly.
• Mycophenolate mofetil
Immunosuppressant agent. Patients treated with Methotrexate at the entry of the study,recommended dose 500 mg twice daily for 2 weeks increasing to 1gm twice daily.
• Cyclophosphamide
Immunosuppressant agent. Patients treated with Methotrexate at the entry of the study, recommend use (i) IV. Minimum monthly dose 500mg/m2 with a recommended duration of 6-12 months. (ii) Oral. 1-2mg/day with a recommended duration of 12 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin score as measured by modified rodnan skin score		24 months	No
Secondary	Pulmonary function as measured by right ventricular systolic pressure (RVSP) or pulmonary artery pressure (PAP)		24 months	No
Secondary	Echocardiographic findings		24 months	No
Secondary	Cochin hand function		24 months	No
Secondary	Fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) scale		24 months	No
Secondary	Short form 36 questionnaire (SF-36)		24 months	No
Secondary	Scleroderma Health Assessment Questionnaire		24 months	No
Secondary	Haemoglobin		24 months	No
Secondary	Erythrocyte sedimentation rate		24 months	No
Secondary	Estimated glomerular filtration rate (eGFR)		24 months	No