Systemic sclerosis Musculoskeletal Diseases Systemic sclerosis
Conditions
Interventions
Current interventions as of 27/04/2020:
Participants are asked to sign a consent form following a full explanation of the study. Before any treatment is given, individuals are asked to
Sponsors
The University of Manchester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients presenting with diffuse cutaneous systemic sclerosis with skin involvement extending to the proximal limb and/or trunk 2. Male or female age = 18 years 3. Skin involvement of less than 3 years defined by patient report or clinician opinion 4. Patient is able and willing to follow the requirements of the study 5. Fully written informed consent
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 27/04/2020: 1. Patients with significant uncontrolled Stage 1 Hypertension (clinic BP > 140/90mmHg). Patients with previous hypertension which is controlled (clinic BP 140/90mmHg). Patients with previous hypertension which is controlled (clinic BP < 140/90mmHg) for at least 4 weeks are considered eligible 2. Previous renal crisis or significant renal impairment (estimated Glomerular Filtration Rate (eGFR) < 40 ml/min) 3. Patients currently on steroid therapy, or previous steroid therapy within the last 4 weeks, with the exception of inhaled steroids for respiratory diseases 4. Patients currently participating in another randomised controlled trial of an investigational agent or device, or previous participation within the last 30 days 5. Patients currently receiving an immunosuppressant or biologic therapy the dose of which has changed in the last 4 weeks, or is likely to change during the first 3 months of study treatment 6. Patients with major myositis or inflammatory arthritis. Patients with low level myositis or inflammatory arthritis are eligible for inclusion (for example, in the case of myositis, a creatine kinase less than 4 times the upper limit of normal or myositis only demonstrable on magnetic resonance imaging). 7. Female patients who are pregnant at time of screening 8. Patients with significant inflammatory bowel disease as judged by the investigator 9. It is important that patients do not suddenly stop taking the study medication
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/04/2020: 1. Functional ability and pain are measured using the HAQ-DI at six weeks and six months 2. Skin score is measured using the mRSS at six weeks and six months 3. Percentage change in skin score from baseline is measured using the mRSS at six weeks, three months and six months 4. Functional ability, to complement the HAQ-DI, will be measured by the 11 point scleroderma functional index at baseline, six weeks, three months and six months 5. Pain is measured using the visual analogue scale (part of the HAQ-DI) at baseline, six weeks, three months and six months 6. Pruritus is measured using the 5-D Itch questionnaire at baseline, six weeks, three months and six months 7. Hand function is measured using the Cochin Hand Function scale at baseline, six weeks, three months and six months 8. Fatigue is measured using the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire at baseline, six weeks, three months and six months 9. Anxiety and depression are measured using the Hospital Anxiety and Depression Scale at baseline, six weeks, three months and six months 10. Helplessness is measured using the Helplessness questionnaire at baseline, six weeks, three months and six months 11. Health-related quality of life is measured using the Short Form (36) Health Survey (version 2) (SF-36v2) and the EuroQol five dimensions questionnaire (EQ-5D) at baseline, six weeks, three months and six months 12. A patient global assessment and physician global assessment are measured using a visual analogue scale at baseline, six weeks, three months and six months 13. Digital Ulcer Count, Tendon Friction Rubs and joint count are measured at baseline, six weeks, three months and six months 14. Arthritis Inde | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Functional ability is measured using the Health Assessment Questionnaire Disability Index (HAQ-DI) at baseline and three months 2. Pain is measured using the Health Assessment Questionnaire Disability Index (HAQ-DI) at baseline and three months 3. Skin score is measured using the modified Rodnan skin score (mRSS) at baseline and three months | — |
Countries
United Kingdom
Contacts
Public ContactDeb Griffiths-Jones
Outcome results
None listed