Prednisolone in Early Diffuse Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT03708718
• Date of registration: 08/10/2018
• Prospective Registration: No
• Primary sponsor: Prof. Ariane herrick
• Public title: Prednisolone in Early Diffuse Systemic Sclerosis PRedSS
• Scientific title: 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)
• Date of first enrolment: December 21, 2017
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03708718
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Professor Ariane Herrick
• Affiliation: University of Manchester

Key inclusion & exclusion criteria

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 the requirements of the study.

5. Fully written informed consent.

Exclusion Criteria:

1. Patients with significant uncontrolled Stage 1 Hypertension (clinic BP >140/90mmHg
i.e. either >140mmHg OR >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 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. Female patients who are breastfeeding.

9. Patients with significant inflammatory bowel disease as judged by the investigator.

10. It is important that patients do not suddenly stop taking the study medication.
Patients who do not fully understand this, will be excluded.

11. Patients who are unwilling or unable to provide informed consent.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Sclerosis

Intervention(s)

Drug: Prednisolone 5 mg

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

Primary Outcome(s)

modified Rodnan Skin Score (mRSS) [Time Frame: Baseline to 3 months]

Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: Baseline to 3 months]

Secondary Outcome(s)

Assessment of pain - Clinician assessment [Time Frame: Baseline to 6 weeks, 3 months and 6 months]

Health related quality of life - Assessed by Questionnaire [Time Frame: Baseline to 6 weeks, 3 months and 6 months]

Pain and disability [Time Frame: Baseline to 6 weeks and 6 months]

Anxiety and depression - Assessed by questionnaire [Time Frame: Baseline to 6 weeks, 3 months and 6 months]

Functional ability - Assessed by Questionnaire [Time Frame: Baseline to 6 weeks, 3 months and 6 months]

Quality of life and functional ability - Assessed by Questionnaire [Time Frame: Baseline to 6 weeks and 6 months]

Pain and disability - Assessed by Questionnaire [Time Frame: Baseline to 6 weeks, 3 months and 6 months]

Hand function - Assessed by Questionnaire [Time Frame: Baseline to 6 weeks, 3 months and 6 months]

Pain and disability [Time Frame: Baseline to 6 weeks, 3 months and 6 months]

Fatigue - Assessed by Questionnaire [Time Frame: Baseline to 6 weeks, 3 months and 6 months]

Pain associated with itch - Assessed by Questionnaire [Time Frame: Baseline to 6 weeks, 3 months and 6 months]

Secondary ID(s)

119220

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Versus Arthritis