Rheumatoid ArthritisTEMPLATENCT06544343
Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy
A study testing Remote Monitoring and On site monitoring in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by University Of Perugia at 1 site in Italy.
Trial summary
Systemic autoimmune and chronic inflammatory diseases are a group of chronic illnesses whose treatment is usually very prolonged, often lifelong, and is essential to keep the disease under control, thus reducing the risk of complications and allowing the best possible quality of life for patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus
- What is being tested?
- Remote Monitoring and On site monitoring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to 18 Mar 2026
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient with one of the following conditions
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Spondyloarthritis
- Ankylosing Spondylitis
- Systemic Sclerosis
Show all 22Show fewer
- Systemic Lupus Erythematosus
- Sjogren's Disease who are prescribed a new immunosuppressive medication for the treatment of their disease among the following:
- Methotrexate
- Sulfasalazine
- Leflunomide
- Mycophenolate Mofetil
- Azathioprine
- Cyclosporine A
- Tacrolimus
- TNF inhibitors (etanercept, adalimumab, golimumab, certolizumab pegol)
- IL6 inhibitors (tocilizumab)
- IL-17 inhibitors (secukinumab, ixekizumab)
- IL-23 inhibitors (ustekinumab, guselkumab, risankizumab)
- JAK-inhibitors (tofacitinib, baricitinib, upadacitinib, filgotinib)
- Belimumab
- Anifrolumab
Who cannot join
- Treatment with a medication not approved for the condition
- Inability to use a device for remote call, not even with the help of a caregiver
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Rheumatology Unit - Perugia Univeristy Hospital
Perugia, PG, 06129
Elena Bartoloni, MD, 0755783975 ext. +39, elena.bartolonibocci@unipg.it
Giacomo Cafaro, MD PhD, 0755783975 ext. +39, giacomo.cafaro@unipg.it
About this study
Official title: Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy in Patients With Rheumatologic Diseases: Comparison With Standard Management
Systemic autoimmune and chronic inflammatory diseases are a group of chronic illnesses whose treatment is usually very prolonged, often lifelong, and is essential to keep the disease under control, thus reducing the risk of complications and allowing the best possible quality of life for patients.
The drugs used for treating these diseases are mostly immunosuppressants, which reduce the activity of the immune system, whose alteration is responsible for the disease. Although all available drugs are effective for treating these diseases, for reasons largely unknown, each drug is effective only in a percentage of patients. As a result, it is often necessary to try several different treatments before identifying an effective one for the individual patient.
The therapeutic effects are often slow, and it is therefore necessary to take a treatment for weeks or months before its effectiveness can be determined. The initial period is also when side effects most often appear. The aim of this study is to evaluate whether the addition of remote monitoring visits and other patient support services to traditional periodic medical visits in the first months after the introduction of a new treatment leads to an improvement in adherence, response, and quality of life for the patient.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Spondyloarthritis, Axial, Ankylosing Spondylitis
- Being tested
- Remote Monitoring, On site monitoring
- Keywords
- Immunosuppression, Quality of Life
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Axial Spondyloarthritis, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote MonitoringOther
Follow-up at outpatient clinic at 3 and 6 months from drug prescription Two remote consultations at 15 and 45 days from drug prescription
On site monitoringOther
Follow-up at outpatient clinic at 3 and 6 months from drug prescription.
| Study group | Role | What they receive |
|---|---|---|
| Remote Monitoring | Experimental | Not described Receives: Other: Remote Monitoring; Other: On site monitoring |
| On site only | Placebo comparator | Not described Receives: Other: On site monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment persistence
Percentage of patients taking the same medication prescribed at baseline
Measured: 6 months
Secondary outcomes (30)
Treatment Persistence
Percentage of patients taking the same medication prescribed at baseline
Measured: 3 months
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)
Only applies to rheumatoid arthritis patients
Measured: 3 months
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)
Only applies to rheumatoid arthritis patients
Measured: 6 months
Psoriatic Arthritis Disease Activity Score (PASDAS)
Only applies to psoriatic arthritis patients
Measured: 3 months
Psoriatic Arthritis Disease Activity Score (PASDAS)
Only applies to psoriatic arthritis patients
Measured: 6 months
Body Surface Area (BSA)
Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients
Measured: 3 months
Body Surface Area (BSA)
Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients
Measured: 6 months
Minimal Disease Activity (MDA)
Binary outcome. Only applies to psoriatic arthritis patients
Measured: 3 months
Minimal Disease Activity (MDA)
Binary outcome. Only applies to psoriatic arthritis patients
Measured: 6 months
Modified Rodnan's skin score
Only applies to systemic sclerosis patients
Measured: 3 months
Modified Rodnan's skin score
Only applies to systemic sclerosis patients
Measured: 6 months
Medical Research Council (MRC) dyspnoea scale
Only applies to systemic sclerosis patients with interstitial lung disease
Measured: 3 months
Medical Research Council (MRC) dyspnoea scale
Only applies to systemic sclerosis patients with interstitial lung disease
Measured: 6 months
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Only applies to Sjogren's disease patients
Measured: 3 months
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Only applies to Sjogren's disease patients
Measured: 6 months
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Only applies to Sjogren's disease patients
Measured: 3 months
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Only applies to Sjogren's disease patients
Measured: 6 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
Only applies to systemic lupus erythematosus patients
Measured: 3 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
Only applies to systemic lupus erythematosus patients
Measured: 6 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Only applies to ankylosing spondylitis and axial spondyloarthritis patients
Measured: 3 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Only applies to ankylosing spondylitis and axial spondyloarthritis patients
Measured: 6 months
Health Assessment Questionnaire Disability Index (HAQ-DI)
Range 0 (best condition) - 3 (worst condition)
Measured: 3 months
Health Assessment Questionnaire Disability Index (HAQ-DI)
Range 0 (best condition) - 3 (worst condition)
Measured: 6 months
Anxiety and Depression
Hospital Anxiety and Depression Scale - Anxiety and Depression range 0 - 21 each (higher values mean higher degrees of depression or anxiety)
Measured: 3 months
Anxiety and Depression
Hospital Anxiety and Depression Scale - Anxiety and Depression range 0 - 21 each (higher values mean higher degrees of depression or anxiety)
Measured: 6 months
EQ-5D-5L score
The score measures quality of life and includes 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which is scored from 1 (perfect health) to 5 (complete inability).
Measured: 3 months
EQ-5D-5L score
The score measures quality of life and includes 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which is scored from 1 (perfect health) to 5 (complete inability).
Measured: 6 months
Number of phone calls to Rheumatology Outpatient Clinic
Measured: 6 months
Number of additional, unscheduled rheumatology consultations
Measured: 6 months
Number of consultations to GP due to prescribed treatment-related issues
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jul 2024
- Primary completion18 Mar 2026 (estimated)
- Study completion18 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Bartoloni Bocci, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544343
- Sponsor's protocol ID
- 4663/24
- Acronym
- TEMPLATE
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Remote Monitoring in the Management of Chronic Immunosuppressive Therapy in Patients With Rheumatologic Diseases: Comparison With Standard Management
- ClinicalTrials.gov ID
- NCT06544343
- Acronym / sponsor ID
- TEMPLATE / 4663/24
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Spondyloarthritis, Axial, Ankylosing Spondylitis
- Keywords
- Immunosuppression, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 18 Mar 2026 (estimated)
- Study completion
- 18 Mar 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
Systemic autoimmune and chronic inflammatory diseases are a group of chronic illnesses whose treatment is usually very prolonged, often lifelong, and is essential to keep the disease under control, thus reducing the risk of complications and allowing the best possible quality of life for patients.
The drugs used for treating these diseases are mostly immunosuppressants, which reduce the activity of the immune system, whose alteration is responsible for the disease. Although all available drugs are effective for treating these diseases, for reasons largely unknown, each drug is effective only in a percentage of patients. As a result, it is often necessary to try several different treatments before identifying an effective one for the individual patient.
The therapeutic effects are often slow, and it is therefore necessary to take a treatment for weeks or months before its effectiveness can be determined. The initial period is also when side effects most often appear. The aim of this study is to evaluate whether the addition of remote monitoring visits and other patient support services to traditional periodic medical visits in the first months after the introduction of a new treatment leads to an improvement in adherence, response, and quality of life for the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Monitoring | Experimental | Other: Remote Monitoring, Other: On site monitoring |
| On site only | Placebo comparator | Other: On site monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Any patient with one of the following conditions
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Spondyloarthritis
- Ankylosing Spondylitis
Key exclusion criteria (2 listed)
- Treatment with a medication not approved for the condition
- Inability to use a device for remote call, not even with the help of a caregiver
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 |
|---|---|---|
| Remote MonitoringFollow-up at outpatient clinic at 3 and 6 months from drug prescription Two remote consultations at 15 and 45 days from drug prescription | Other | Remote Monitoring |
| On site monitoringFollow-up at outpatient clinic at 3 and 6 months from drug prescription. | Other | On site only, Remote Monitoring |
Primary outcome
Treatment persistence
Time frame: 6 months
Percentage of patients taking the same medication prescribed at baseline
30 secondary outcomes
Treatment Persistence
Time frame: 3 months
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)
Time frame: 3 months
Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)
Time frame: 6 months
Psoriatic Arthritis Disease Activity Score (PASDAS)
Time frame: 3 months
Psoriatic Arthritis Disease Activity Score (PASDAS)
Time frame: 6 months
Body Surface Area (BSA)
Time frame: 3 months
Body Surface Area (BSA)
Time frame: 6 months
Minimal Disease Activity (MDA)
Time frame: 3 months
Minimal Disease Activity (MDA)
Time frame: 6 months
Modified Rodnan's skin score
Time frame: 3 months
Modified Rodnan's skin score
Time frame: 6 months
Medical Research Council (MRC) dyspnoea scale
Time frame: 3 months
Medical Research Council (MRC) dyspnoea scale
Time frame: 6 months
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Time frame: 3 months
EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
Time frame: 6 months
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Time frame: 3 months
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Time frame: 6 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
Time frame: 3 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K
Time frame: 6 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: 3 months
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: 6 months
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: 3 months
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: 6 months
Anxiety and Depression
Time frame: 3 months
Anxiety and Depression
Time frame: 6 months
EQ-5D-5L score
Time frame: 3 months
EQ-5D-5L score
Time frame: 6 months
Number of phone calls to Rheumatology Outpatient Clinic
Time frame: 6 months
Number of additional, unscheduled rheumatology consultations
Time frame: 6 months
Number of consultations to GP due to prescribed treatment-related issues
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Rheumatology Unit - Perugia Univeristy Hospital
Perugia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Monitoring and On site monitoring in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by University Of Perugia at 1 site in Italy.
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 22 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment persistence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2024.