Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis, Spondyloarthritis, Axial, Systemic Lupus Erythematosus, Systemic Sclerosis
Conditions
Keywords
Immunosuppression, Quality of Life
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.
Interventions
OTHERRemote Monitoring
Follow-up at outpatient clinic at 3 and 6 months from drug prescription Two remote consultations at 15 and 45 days from drug prescription
OTHEROn site monitoring
Follow-up at outpatient clinic at 3 and 6 months from drug prescription.
Sponsors
University Of Perugia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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 * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment persistence | 6 months | Percentage of patients taking the same medication prescribed at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity score on 28 joints with C-Reactive Protein (DAS28-CRP) | 3 months | Only applies to rheumatoid arthritis patients |
| Psoriatic Arthritis Disease Activity Score (PASDAS) | 3 months | Only applies to psoriatic arthritis patients |
| Body Surface Area (BSA) | 3 months | Percentage of skin surface with psoriatic lesions. Only applies to psoriatic arthritis patients |
| Minimal Disease Activity (MDA) | 3 months | Binary outcome. Only applies to psoriatic arthritis patients |
| Modified Rodnan's skin score | 3 months | Only applies to systemic sclerosis patients |
| Medical Research Council (MRC) dyspnoea scale | 3 months | Only applies to systemic sclerosis patients with interstitial lung disease |
| EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) | 3 months | Only applies to Sjogren's disease patients |
| EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) | 3 months | Only applies to Sjogren's disease patients |
| Treatment Persistence | 3 months | Percentage of patients taking the same medication prescribed at baseline |
| Ankylosing Spondylitis Disease Activity Score (ASDAS) | 3 months | Only applies to ankylosing spondylitis and axial spondyloarthritis patients |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | 3 months | Range 0 (best condition) - 3 (worst condition) |
| Anxiety and Depression | 3 months | Hospital Anxiety and Depression Scale - Anxiety and Depression range 0 - 21 each (higher values mean higher degrees of depression or anxiety) |
| EQ-5D-5L score | 3 months | 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). |
| Number of phone calls to Rheumatology Outpatient Clinic | 6 months | — |
| Number of additional, unscheduled rheumatology consultations | 6 months | — |
| Number of consultations to GP due to prescribed treatment-related issues | 6 months | — |
| Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)-2K | 3 months | Only applies to systemic lupus erythematosus patients |
Countries
Italy
Outcome results
None listed