NCT06544343

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2026

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

July 19, 2024

Last Update Submit

August 6, 2024

Conditions

Rheumatoid ArthritisPsoriatic ArthritisSystemic Lupus ErythematosusSystemic SclerosisSpondyloarthritis, AxialAnkylosing Spondylitis

Keywords

ImmunosuppressionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Treatment persistence

    Percentage of patients taking the same medication prescribed at baseline

    6 months

Secondary Outcomes (30)

  • Treatment Persistence

    3 months

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

    3 months

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

    6 months

  • Psoriatic Arthritis Disease Activity Score (PASDAS)

    3 months

  • Psoriatic Arthritis Disease Activity Score (PASDAS)

    6 months

  • +25 more secondary outcomes

Study Arms (2)

Remote Monitoring

EXPERIMENTAL
Other: Remote MonitoringOther: On site monitoring

On site only

PLACEBO COMPARATOR
Other: On site monitoring

Interventions

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

Remote Monitoring
On site monitoringOTHER

Follow-up at outpatient clinic at 3 and 6 months from drug prescription.

On site onlyRemote Monitoring

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient with one of the following conditions
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Spondyloarthritis
  • Ankylosing Spondylitis
  • Systemic Sclerosis
  • 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
  • +7 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology Unit - Perugia Univeristy Hospital

Perugia, PG, 06129, Italy

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis, PsoriaticLupus Erythematosus, SystemicScleroderma, SystemicAxial SpondyloarthritisSpondylitis, Ankylosing

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesAnkylosis

Intervention Hierarchy (Ancestors)

TelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 19, 2024

First Posted

August 9, 2024

Study Start

July 1, 2024

Primary Completion

March 18, 2026

Study Completion

March 18, 2026

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)