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Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis (ESOS)

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ClinicalTrials.gov Identifier: NCT02339441
Recruitment Status : Completed
First Posted : January 15, 2015
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Early Diffuse Cutaneous Systemic Sclerosis Drug: Methotrexate Drug: Mycophenolate mofetil Drug: Cyclophosphamide

Detailed 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.

Study Design

Study Type : Observational
Actual Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis
Study Start Date : June 2010
Primary Completion Date : December 2015
Study Completion Date : March 2016


Groups and Cohorts

Group/Cohort Intervention/treatment
Methotrexate
Patients treated with Methotrexate at the entry of the study.
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
Patients treated with Mycophenolate Mofetil at the entry of the study.
Drug: 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
Patients treated with Cyclophosphamide at the entry of the study
Drug: 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.
No Immunosuppressant
Patients without immunosuppressant treatment at the entry of the study


Outcome Measures

Primary Outcome Measures :
  1. Skin score as measured by modified rodnan skin score [ Time Frame: 24 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligibility:

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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339441


Sponsors and Collaborators
University of Manchester
Investigators
Principal Investigator: Ariane Herrick, MD, phD University of Manchester
More Information

Responsible Party: Prof. Ariane herrick, Professor, University of Manchester
ClinicalTrials.gov Identifier: NCT02339441     History of Changes
Other Study ID Numbers: 10H101429
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by Prof. Ariane herrick, University of Manchester:
Systemic sclerosis

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Cyclophosphamide
Methotrexate
Immunosuppressive Agents
Mycophenolic Acid
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents