A Phase II randomised study of oral prednisolone in early diffuse cutaneous systemic sclerosis (initially double-blind, then switched to open-label because of COVID-19)

The University of Manchester0 sites35 target enrollmentJune 27, 2017

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: The University of Manchester
Enrollment: 35
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2020 Protocol article in https://journals.sagepub.com/doi/full/10.1177/2397198320957552 protocol (added 11/09/2020)

Registry

who.int

Start Date

June 27, 2017

End Date

May 27, 2021

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

The University of Manchester

Eligibility 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

•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) 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 or topical steroids for skin disease
•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 prior to the baseline visit, 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