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Prednisolone in Early Diffuse Systemic Sclerosis

NCT03708718 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2021-07-30

No results posted yet for this study

Summary

This is a randomised placebo-controlled study of moderate dose prednisolone for 6 months in patients with early diffuse cutaneous systemic sclerosis (dcSSc). Seventy-two patients within 3 years of the onset of skin thickening will be recruited from 14 UK centres over 3 years. Co-primary end-points will be the Health Assessment Questionnaire Disability Index (HAQ-DI) and the modified Rodnan skin score (mRSS). Patients will be assessed 5 times: screening, baseline, 6 weeks, 3 and 6 months, with a code-break on exit from the study at 6 months.

Please note: From August 2020, the trial was re-started following halt due to Covid-19 as open-label. The placebo arm is the 'no treatment' arm and there is no longer a code-break at study exit.

Conditions

Interventions

DRUG

Prednisolone 5 mg

5mg prednisolone, once a day for 6 months

DRUG

Placebo oral capsule; From August 2020 'no additional treatment'

Matched placebo capsule, once a day for 6 months; From August 2020 - no additional treatment above standard of care medication

Sponsors & Collaborators

  • Versus Arthritis

    collaborator OTHER

  • Prof. Ariane herrick

    lead OTHER

Principal Investigators

  • Professor Ariane Herrick · University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2021-03-04
Completion
2021-05-27

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03708718 on ClinicalTrials.gov