Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2017-12-21
2021-05-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis
NCT02635204
A Study to Evaluate the Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis
NCT05896527
To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
NCT04566666
A Study of PRCL-02 in Moderate to Severe Chronic Plaque Psoriasis
NCT03614078
A Study of PRCL-02 in Healthy Volunteers and Plaque Psoriasis
NCT03062618
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Our aim is to investigate whether treatment with the steroid prednisolone is beneficial in patients with early diffuse cutaneous systemic sclerosis (also termed "scleroderma"). This is a controversial subject. Although it is very possible that prednisolone can help relieve the severe pain, itching, and disability (due to contractures and musculoskeletal involvement) of early diffuse scleroderma, doctors are often reluctant to prescribe prednisolone because of possible side effects, particularly an increased risk of serious kidney problems. Our proposed trial, treating patients with either prednisolone or placebo therapy for 6 months, should provide clinicians with a long awaited answer to the important clinical question: Can prednisolone be used as a therapy in this group of patients?
The study, funded by Arthritis Research UK, aims to determine:
1. Is moderate dose prednisolone effective in reducing pain, disability and skin thickening in patients with early diffuse scleroderma?
2. Is moderate dose prednisolone a safe therapy in patients with early diffuse scleroderma (with particular reference to kidney function)?
If the answer to both is 'yes', then prednisolone therapy will be much more widely prescribed for this patient group.
The patient population will be selected from individuals with early dcSSc, as defined by skin involvement of less than 3 years, who are considered potentially able to benefit from this treatment. Following screening, to minimise bias, eligible patients will be randomised at the baseline visit to receive either daily moderate dose prednisolone (as determined by body weight) or a matched placebo. To further eliminate subjective and unrecognised bias both the research team and patients will be blind to the randomisation. A placebo control, as opposed to an active treatment control, will be administered. This is necessary as the study treatment is adjunctive to and not a substitute for any other therapies which may be prescribed, such as immunosuppressant therapies.
Patients will attend on 5 occasions (screen, baseline, 6 weeks, 3 and 6 months). All patients will be considered off-study at the end of the 6 month visit whereupon the treatment code will be broken. At each visit a number of measurements will be taken including functional ability, degree of skin involvement (skin score), mood and kidney function. This will allow us to determine whether 'active' (prednisolone) therapy is effective and free from serious side-effects.
Please note: from August 2020, due to Covid-19 the trial was re-designed and re-started following trial halt as open-label. A placebo is no longer required. The aims, primary outcome measures and number of visits remain unchanged. However, to further mitigate the ongoing impact of Covid-19, the screen and baseline assessments may now be conducted at the same visit. Remote visits can also be carried out at 6 weeks and 6 months, if necessary.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
From August 2020: Under the open-label design, patients are allocated to receive prednisolone or no additional treatment. The randomisation allocation is 1:1.
TREATMENT
TRIPLE
From August 2020: Open-Label - The patient, site research team and site pharmacy are unblind. The trial management team are unblind for patients recruited from August 2020 onwards but remain blind to patients randomised to trial under the double-blind design. The trial monitor and trial statistician continue to be unblind for all patients randomised to trial.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prednisolone
Prednisolone 5mg enteric-coated tablets, over-encapsulated in a hard gelatine capsule and filled with lactose BP. The prednisolone will be self-administered, orally with water before or after a meal once a day. Dosing will be continuous for a total of 6 months.
The total dose prescribed will be equivalent to approximately 0.3mg/kg/day. The minimum dose prescribed will be 10mg per day (2 capsules) and a maximum of 30mg per day (6 capsules).
From August 2020: The prednisolone is no longer over-encapsulated. Prednisolone 5mg enteric-coated tablets will be prescribed and taken as above.
Prednisolone 5 mg
5mg prednisolone, once a day for 6 months
Placebo oral capsule; From August 2020 - 'no additional treatment'
The placebo will be a hard gelatine capsule filled with lactose BP and identically matched to the prednisolone capsules. The placebo will be self-administered once a day, orally with water before or after a meal. Dosing will be continuous for a total of 6 months.
From August 2020 - no placebo capsule will be administered.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prednisolone 5 mg
5mg prednisolone, once a day for 6 months
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Versus Arthritis
OTHER
Prof. Ariane herrick
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Ariane herrick
Professor of Rheumatology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Professor Ariane Herrick
Role: PRINCIPAL_INVESTIGATOR
University of Manchester
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aberdeen Royal Infirmary - NHS Grampian
Aberdeen, Aberdeenshire, United Kingdom
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, United Kingdom
Glasgow Royal Infirmary -
Glasgow, Lanarkshire, United Kingdom
Aintree University Hospitals NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
Queen's Medical Centre - Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom
Royal National Hospital For Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
Bath, Somerset, United Kingdom
Royal Hallamshire Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
Freeman Hospital - The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, West Midlands, United Kingdom
Leeds Institute of Rheumatic and Musculoskeletal Medicine
Leeds, West Yorkshire, United Kingdom
Southmead Hospital Bristol - North Bristol NHS Trust
Bristol, , United Kingdom
Ninewells Hospital and Medical School - NHS Tayside
Dundee, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Griffiths-Jones DJ, Garcia YS, Ryder WD, Pauling JD, Hall F, Lanyon P, Bhat S, Douglas K, Gunawardena H, Akil M, Anderson M, Griffiths B, Del Galdo F, Youssef H, Madhok R, Arthurs B, Buch M, Fligelstone K, Zubair M, Mason JC, Denton CP, Herrick AL. A Phase II randomized controlled trial of oral prednisolone in early diffuse cutaneous systemic sclerosis (PRedSS). Rheumatology (Oxford). 2023 Sep 1;62(9):3133-3138. doi: 10.1093/rheumatology/kead012.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
119220
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.