Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis (ESOS)

University of Manchester

Status: Completed

Conditions: Early Diffuse Cutaneous Systemic Sclerosis

Treatments: Drug: Cyclophosphamide; Drug: Mycophenolate mofetil; Drug: Methotrexate

Study type: Observational

Funder types: Other

Identifiers

NCT02339441

10H101429

Details and patient eligibility

About

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

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

320 participants in 4 patient groups

Methotrexate

Description:

Patients treated with Methotrexate at the entry of the study.

Treatment:

Drug: Methotrexate

Mycophenolate Mofetil

Description:

Patients treated with Mycophenolate Mofetil at the entry of the study.

Treatment:

Drug: Mycophenolate mofetil

Cyclophosphamide

Description:

Patients treated with Cyclophosphamide at the entry of the study

Treatment:

Drug: Cyclophosphamide

No Immunosuppressant

Description:

Patients without immunosuppressant treatment at the entry of the study