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
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Condition or disease | Intervention/treatment |
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Early Diffuse Cutaneous Systemic Sclerosis | Drug: Methotrexate Drug: Mycophenolate mofetil Drug: Cyclophosphamide |
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 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | March 2016 |

Group/Cohort | Intervention/treatment |
---|---|
Methotrexate
Patients treated with Methotrexate at the entry of the study.
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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.
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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
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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
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- Skin score as measured by modified rodnan skin score [ Time Frame: 24 months ]
- Pulmonary function as measured by right ventricular systolic pressure (RVSP) or pulmonary artery pressure (PAP) [ Time Frame: 24 months ]
- Echocardiographic findings [ Time Frame: 24 months ]
- Cochin hand function [ Time Frame: 24 months ]
- Fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) scale [ Time Frame: 24 months ]
- Short form 36 questionnaire (SF-36) [ Time Frame: 24 months ]
- Scleroderma Health Assessment Questionnaire [ Time Frame: 24 months ]
- Haemoglobin [ Time Frame: 24 months ]
- Erythrocyte sedimentation rate [ Time Frame: 24 months ]
- Estimated glomerular filtration rate (eGFR) [ Time Frame: 24 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Eligibility:
Age > 18 Skin thickening < 3 years Immunosuppressant use < 4 months Proximal skin involvement to face/neck, elbow or knee
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

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
Principal Investigator: | Ariane Herrick, MD, phD | University of Manchester |
Responsible Party: | Prof. Ariane herrick, Professor, University of Manchester |
ClinicalTrials.gov Identifier: | NCT02339441 |
Other Study ID Numbers: |
10H101429 |
First Posted: | January 15, 2015 Key Record Dates |
Last Update Posted: | May 13, 2016 |
Last Verified: | May 2016 |
Systemic sclerosis |
Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Pathologic Processes Connective Tissue Diseases Skin Diseases Mycophenolic Acid Cyclophosphamide Methotrexate Immunosuppressive Agents 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 |