A Phase II Randomised Controlled Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis - PRedSS: Prednisolone in Early Diffuse Systemic Sclerosis. Version 1.0

Research Governance and Integrity, University of Manchester0 个研究点目标入组 72 人开始时间: 2018年5月8日最近更新: 2018年5月14日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Research Governance and Integrity, University of Manchester