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Completed

NCT Number: NCT02339441

Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis

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

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Key information

Conditions

Early Diffuse Cutaneous Systemic Sclerosis Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. Skin score as measured by modified rodnan skin score

    Time frame: 24 months

Secondary outcomes

  1. Pulmonary function as measured by right ventricular systolic pressure (RVSP) or pulmonary artery pressure (PAP)

    Time frame: 24 months

  2. Echocardiographic findings

    Time frame: 24 months

  3. Cochin hand function

    Time frame: 24 months

  4. Fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) scale

    Time frame: 24 months

  5. Short form 36 questionnaire (SF-36)

    Time frame: 24 months

  6. Scleroderma Health Assessment Questionnaire

    Time frame: 24 months

  7. Haemoglobin

    Time frame: 24 months

  8. Erythrocyte sedimentation rate

    Time frame: 24 months

  9. Estimated glomerular filtration rate (eGFR)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Acronym: ESOS

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Jan 15, 2015
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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