Systemic SclerosisPhase 2PRedSSNCT03708718
Prednisolone in Early Diffuse Systemic Sclerosis
A Phase 2 study testing Prednisolone 5 mg in people with Systemic Sclerosis, run by Prof. Ariane herrick at 14 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Prednisolone 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- 21 Dec 2017to 27 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with dcSSc with skin involvement extending to the proximal limb and/or trunk.
- Male or female age ≥ 18 years.
- Skin involvement of less than 3 years defined by patient report or clinician opinion.
- Patient is able and willing to follow the requirements of the study.
- Fully written informed consent.
Who cannot join
- 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.
- Previous renal crisis or significant renal impairment (estimated Glomerular Filtration Rate (eGFR) < 40 ml/min).
- Patients currently on steroid therapy, or previous steroid therapy within the last 4 weeks, with the exception of inhaled steroids for respiratory diseases.
- Patients currently participating in another randomised controlled trial of an investigational agent or device, or previous participation within the last 30 days.
- 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.
- 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).
Show all 11Show fewer
- Female patients who are pregnant at time of screening.
- Female patients who are breastfeeding.
- Patients with significant inflammatory bowel disease as judged by the investigator.
- It is important that patients do not suddenly stop taking the study medication. Patients who do not fully understand this, will be excluded.
- Patients who are unwilling or unable to provide informed consent.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Aberdeen Royal Infirmary - NHS Grampian
Aberdeen, Aberdeenshire, AB25 2ZN
Royal National Hospital For Rheumatic Diseases - Royal United Hospitals Bath NHS Foundation Trust
Bath, Somerset, BA1 1RL
Southmead Hospital Bristol - North Bristol NHS Trust
Bristol, BS10 5NB
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
The Dudley Group NHS Foundation Trust
Dudley, West Midlands, DY1 2HQ
Ninewells Hospital and Medical School - NHS Tayside
Dundee, DD1 9SY
Glasgow Royal Infirmary -
Glasgow, Lanarkshire, G4 0SF
Leeds Institute of Rheumatic and Musculoskeletal Medicine
Leeds, West Yorkshire, LS7 4SA
Aintree University Hospitals NHS Foundation Trust
Liverpool, Merseyside, L9 7AL
Royal Free London NHS Foundation Trust
London, NW3 2QG
Freeman Hospital - The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Queen's Medical Centre - Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD
Royal Hallamshire Hospital - Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF
About this study
Official 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)
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.
Read the detailed description
The study is a non-commercial phase II randomised, double-blind, placebo-controlled, multi-centre study to test moderate dose prednisolone versus placebo in patients with early diffuse cutaneous systemic sclerosis (dcSSc).
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:
- Is moderate dose prednisolone effective in reducing pain, disability and skin thickening in patients with early diffuse scleroderma?
- 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
- Systemic Sclerosis
- Being tested
- Prednisolone 5 mg, Placebo oral capsule; From August 2020 'no additional treatment'
- Keywords
- Diffuse cutaneous systemic sclerosis (dcSSc), Prednisolone, Randomised Controlled Trial, Disability, Pain, Fatigue
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone 5 mgDrug
5mg prednisolone, once a day for 6 months
Placebo oral capsule; From August 2020 'no additional treatment'Drug
Matched placebo capsule, once a day for 6 months; From August 2020 - no additional treatment above standard of care medication
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Active comparator | 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. Receives: Drug: Prednisolone 5 mg |
| Placebo oral capsule; From August 2020 - 'no additional treatment' | Placebo comparator | 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. Receives: Drug: Placebo oral capsule; From August 2020 'no additional treatment' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Assessment Questionnaire Disability Index (HAQ-DI)
The mean difference in HAQ-DI at 3 months
Measured: Baseline to 3 months
modified Rodnan Skin Score (mRSS)
The difference in mRSS at 3 months
Measured: Baseline to 3 months
Secondary outcomes (17)
Quality of life and functional ability - Assessed by Questionnaire
HAQ-DI
Measured: Baseline to 6 weeks and 6 months
Pain and disability
Skin involvement as measured by the mRSS
Measured: Baseline to 6 weeks and 6 months
Functional ability - Assessed by Questionnaire
11-point Scleroderma Functional Index
Measured: Baseline to 6 weeks, 3 months and 6 months
Pain associated with itch - Assessed by Questionnaire
Assessment of Pruritus
Measured: Baseline to 6 weeks, 3 months and 6 months
Hand function - Assessed by Questionnaire
Cochin Hand Function
Measured: Baseline to 6 weeks, 3 months and 6 months
Fatigue - Assessed by Questionnaire
Functional Assessment of Chronic Illness Therapy (FACIT)
Measured: Baseline to 6 weeks, 3 months and 6 months
Anxiety and depression - Assessed by questionnaire
Hospital Anxiety and Depression Scale (HADS) . This questionnaire has 14 questions, each with 4 options designed to assess aspects of mental health
Measured: Baseline to 6 weeks, 3 months and 6 months
Health related quality of life - Assessed by Questionnaire
Helplessness Questionnaire
Measured: Baseline to 6 weeks, 3 months and 6 months
Health related quality of life - Assessed by Questionnaire
Short Form (36) Health Survey
Measured: Baseline to 6 weeks, 3 months and 6 months
Health related quality of Life - Assessed by Questionnaire
EuroQol 5 Dimensions
Measured: Baseline to 6 weeks, 3 months and 6 months
Pain and disability
Patient Global Assessment
Measured: Baseline to 6 weeks, 3 months and 6 months
Pain and disability
Physician Global Assessment
Measured: Baseline to 6 weeks, 3 months and 6 months
Assessment of pain - Clinician assessment
Digital Ulcer Count: The site and total number of ulcers on the hand are recorded by the patients clinician on a diagram of a hand
Measured: Baseline to 6 weeks, 3 months and 6 months
Assessment of pain - Clinician assessment
Tender Friction Rubs - the total number of tendon friction rubs on 12 possible anatomical sites are recorded
Measured: Baseline to 6 weeks, 3 months and 6 months
Assessment of pain - Clinician assessment
Joint Count: The number of tender or swollen joints are assessed from 14 anatomical sites (both left and right side) and recorded out of a total of 28 (14 sites, left and right side) tender joints and 28 swollen joints
Measured: Baseline to 6 weeks, 3 months and 6 months
Pain and disability - Assessed by Questionnaire
Assessment of Arthritis Index
Measured: Baseline to 6 weeks, 3 months and 6 months
Pain and disability
Assessment in percentage change of mRSS
Measured: Baseline to 6 weeks, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start21 Dec 2017
- Primary completion4 Mar 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are allocated to received either prednisolone or matched placebo for the duration of the trial. The allocation is randomised 1:1. From August 2020: Under the open-label design, patients are allocated to receive prednisolone or no additional treatment. The randomisation allocation is 1:1.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Ariane herrick
- Sponsor type
- University, hospital or other
- Collaborators
- Versus Arthritis
- Responsible party
- Sponsor-investigator, Prof. Ariane herrick, University of Manchester
- Investigators
- Professor Ariane Herrick, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708718
- Sponsor's protocol ID
- 119220
- Acronym
- PRedSS
- Status last verified
- Jul 2021
- First submitted
- 8 Oct 2018
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared with collaborating centres. It is undecided if this information will be shared with researchers unconnected with the trial.
Publications
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.
PubMed 36637209
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03708718
- Acronym / sponsor ID
- PRedSS / 119220
- Conditions
- Systemic Sclerosis
- Keywords
- Diffuse cutaneous systemic sclerosis (dcSSc), Prednisolone, Randomised Controlled Trial, Disability, Pain, Fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Prof. Ariane herrickUniversity, hospital or other
- Collaborators
- Versus Arthritis
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a non-commercial phase II randomised, double-blind, placebo-controlled, multi-centre study to test moderate dose prednisolone versus placebo in patients with early diffuse cutaneous systemic sclerosis (dcSSc).
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:
- Is moderate dose prednisolone effective in reducing pain, disability and skin thickening in patients with early diffuse scleroderma?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients are allocated to received either prednisolone or matched placebo for the duration of the trial. The allocation is randomised 1:1. From August 2020: Under the open-label design, patients are allocated to receive prednisolone or no additional treatment. The randomisation allocation is 1:1.
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Active comparator | Drug: Prednisolone 5 mgPrednisolone 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. |
| Placebo oral capsule; From August 2020 - 'no additional treatment' | Placebo comparator | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients presenting with dcSSc with skin involvement extending to the proximal limb and/or trunk.
- Male or female age ≥ 18 years.
- Skin involvement of less than 3 years defined by patient report or clinician opinion.
- Patient is able and willing to follow the requirements of the study.
- Fully written informed consent.
Key exclusion criteria (11 listed)
- 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.
- Previous renal crisis or significant renal impairment (estimated Glomerular Filtration Rate (eGFR) < 40 ml/min).
- Patients currently on steroid therapy, or previous steroid therapy within the last 4 weeks, with the exception of inhaled steroids for respiratory diseases.
- Patients currently participating in another randomised controlled trial of an investigational agent or device, or previous participation within the last 30 days.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisolone 5 mg5mg prednisolone, once a day for 6 months | Drug | Prednisolone |
| 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 | Drug | Placebo oral capsule; From August 2020 - 'no additional treatment' |
Primary outcome
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Baseline to 3 months
The mean difference in HAQ-DI at 3 months
modified Rodnan Skin Score (mRSS)
Time frame: Baseline to 3 months
The difference in mRSS at 3 months
17 secondary outcomes
Quality of life and functional ability - Assessed by Questionnaire
Time frame: Baseline to 6 weeks and 6 months
Pain and disability
Time frame: Baseline to 6 weeks and 6 months
Functional ability - 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
Hand function - Assessed by Questionnaire
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
Anxiety and depression - Assessed by questionnaire
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
Health related quality of life - Assessed by Questionnaire
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, 3 months and 6 months
Pain and disability
Time frame: Baseline to 6 weeks, 3 months and 6 months
Assessment of pain - Clinician assessment
Time frame: Baseline to 6 weeks, 3 months and 6 months
Assessment of pain - Clinician assessment
Time frame: Baseline to 6 weeks, 3 months and 6 months
Assessment of pain - Clinician assessment
Time frame: Baseline to 6 weeks, 3 months and 6 months
Pain and disability - 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Derived from this study: PubMed 36637209Griffiths-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.
- Individual participant dataSharing planned: Undecided. IPD will be shared with collaborating centres. It is undecided if this information will be shared with researchers unconnected with the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Ariane Herrick principal investigator
University of Manchester
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisolone 5 mg in people with Systemic Sclerosis, run by Prof. Ariane herrick at 14 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Assessment Questionnaire Disability Index (HAQ-DI) (time frame: Baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03708718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.