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Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis (ESOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02339441
Recruitment Status : Completed
First Posted : January 15, 2015
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Ariane herrick, University of Manchester

Tracking Information
First Submitted Date December 22, 2014
First Posted Date January 15, 2015
Last Update Posted Date May 13, 2016
Study Start Date June 2010
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2015)
Skin score as measured by modified rodnan skin score [ Time Frame: 24 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 15, 2015)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: January 12, 2015)
  • Pulmonary function as measured by right ventricular systolic pressure (RVSP) or pulmonary artery pressure (PAP) [ Time Frame: 24 months ]
  • Echocardiograhic findings [ Time Frame: 24 months ]
  • Cochin hand function [ Time Frame: 24 months ]
  • Fatigue as measured by the FACIT fatigue 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis
Official Title Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis
Brief Summary The aim of the study is to compare the effectiveness of commonly used immunosuppressant treatments for early diffuse cutaneous systemic sclerosis (SSc).
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition Early Diffuse Cutaneous 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.
  • 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.
Study Groups/Cohorts
  • Methotrexate
    Patients treated with Methotrexate at the entry of the study.
    Intervention: Drug: Methotrexate
  • Mycophenolate Mofetil
    Patients treated with Mycophenolate Mofetil at the entry of the study.
    Intervention: Drug: Mycophenolate mofetil
  • Cyclophosphamide
    Patients treated with Cyclophosphamide at the entry of the study
    Intervention: Drug: Cyclophosphamide
  • No Immunosuppressant
    Patients without immunosuppressant treatment at the entry of the study
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 12, 2015)
320
Original Actual Enrollment Same as current
Actual Study Completion Date March 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02339441
Other Study ID Numbers 10H101429
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Prof. Ariane herrick, University of Manchester
Original Responsible Party Same as current
Current Study Sponsor University of Manchester
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Ariane Herrick, MD, phD University of Manchester
PRS Account University of Manchester
Verification Date May 2016