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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

  • 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

    Recruiting

Other trials in Italy

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.

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 groups in NCT06544343
Study groupRoleWhat they receive
Remote MonitoringExperimentalNot described
Receives: Other: Remote Monitoring; Other: On site monitoring
On site onlyPlacebo comparatorNot described
Receives: Other: On site monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment persistence

    Percentage of patients taking the same medication prescribed at baseline

    Measured: 6 months

Secondary outcomes (30)

  1. Treatment Persistence

    Percentage of patients taking the same medication prescribed at baseline

    Measured: 3 months

  2. Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)

    Only applies to rheumatoid arthritis patients

    Measured: 3 months

  3. Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP)

    Only applies to rheumatoid arthritis patients

    Measured: 6 months

  4. Psoriatic Arthritis Disease Activity Score (PASDAS)

    Only applies to psoriatic arthritis patients

    Measured: 3 months

  5. Psoriatic Arthritis Disease Activity Score (PASDAS)

    Only applies to psoriatic arthritis patients

    Measured: 6 months

  6. Body Surface Area (BSA)

    Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients

    Measured: 3 months

  7. Body Surface Area (BSA)

    Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients

    Measured: 6 months

  8. Minimal Disease Activity (MDA)

    Binary outcome. Only applies to psoriatic arthritis patients

    Measured: 3 months

  9. Minimal Disease Activity (MDA)

    Binary outcome. Only applies to psoriatic arthritis patients

    Measured: 6 months

  10. Modified Rodnan's skin score

    Only applies to systemic sclerosis patients

    Measured: 3 months

  11. Modified Rodnan's skin score

    Only applies to systemic sclerosis patients

    Measured: 6 months

  12. Medical Research Council (MRC) dyspnoea scale

    Only applies to systemic sclerosis patients with interstitial lung disease

    Measured: 3 months

  13. Medical Research Council (MRC) dyspnoea scale

    Only applies to systemic sclerosis patients with interstitial lung disease

    Measured: 6 months

  14. EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

    Only applies to Sjogren's disease patients

    Measured: 3 months

  15. EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

    Only applies to Sjogren's disease patients

    Measured: 6 months

  16. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)

    Only applies to Sjogren's disease patients

    Measured: 3 months

  17. EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)

    Only applies to Sjogren's disease patients

    Measured: 6 months

  18. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K

    Only applies to systemic lupus erythematosus patients

    Measured: 3 months

  19. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K

    Only applies to systemic lupus erythematosus patients

    Measured: 6 months

  20. Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Only applies to ankylosing spondylitis and axial spondyloarthritis patients

    Measured: 3 months

  21. Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Only applies to ankylosing spondylitis and axial spondyloarthritis patients

    Measured: 6 months

  22. Health Assessment Questionnaire Disability Index (HAQ-DI)

    Range 0 (best condition) - 3 (worst condition)

    Measured: 3 months

  23. Health Assessment Questionnaire Disability Index (HAQ-DI)

    Range 0 (best condition) - 3 (worst condition)

    Measured: 6 months

  24. 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

  25. 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

  26. 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

  27. 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

  28. Number of phone calls to Rheumatology Outpatient Clinic

    Measured: 6 months

  29. Number of additional, unscheduled rheumatology consultations

    Measured: 6 months

  30. 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.

  1. First posted9 Aug 2024
  2. Study start1 Jul 2024
  3. Primary completion18 Mar 2026 (estimated)
  4. Study completion18 Mar 2026 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT06544343.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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