A Study of Prednisolone in Patients with Early (within 3 years of onset) Diffuse Cutaneous Scleroderma (Systemic Sclerosis)

Phase 1

• Conditions: Early diffuse cutaneous systemic sclerosis; MedDRA version: 20.0Level: LLTClassification code 10012977Term: Diffuse systemic sclerosisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-002651-25-GB
• Lead Sponsor: Research Governance and Integrity, University of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-08
• Last Update Posted: 14 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1) Patients presenting with dcSSc 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 with the requirements of the study.
5) Fully written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 61
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

1) Patients with significant uncontrolled Stage 1 Hypertension (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. Patients who do not fully understand this, will be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified