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Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis

NCT02339441 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2016-05-13

No results posted yet for this study

Summary

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

Conditions

  • Early Diffuse Cutaneous Systemic Sclerosis

Interventions

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.

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.

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.

Sponsors & Collaborators

  • University of Manchester

    lead OTHER

Principal Investigators

  • Ariane Herrick, MD, phD · University of Manchester

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2015-12-31
Completion
2016-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02339441 on ClinicalTrials.gov