Evaluating Upadacitinib for Psoriatic and Rheumatoid Arthritis
Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis. OPTimising IMAging For The Use In The Follow-Up Of Arthritis: The OPTIMA Study
This study is testing how well Upadacitinib works for people with active Psoriatic Arthritis and Rheumatoid Arthritis over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 178 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Drugs / interventions | Upadacitinib |
| Locations | 14 sites (Legnano, Milano and 13 other locations) |
| Trial ID | NCT06630715 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of Upadacitinib in treating patients with active Psoriatic Arthritis and Rheumatoid Arthritis. Participants will be monitored over six months, with evaluations at baseline and follow-up visits to collect clinical, laboratory, and imaging data. The study will utilize ultrasound and MRI to track disease activity and treatment response. By comparing these outcomes, the study seeks to understand the interrelationship between imaging results and patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with active Psoriatic Arthritis or Rheumatoid Arthritis who are starting therapy with Upadacitinib.
Not a fit: Patients with inactive disease or those not eligible for Upadacitinib therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of Upadacitinib for managing Psoriatic and Rheumatoid Arthritis, potentially improving treatment strategies.
How similar studies have performed: Other studies have shown promising results with Jak-Inhibitors in similar conditions, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
The inclusion criteria for Psoriatic Arthritis patients are:
1. Patients diagnosed with peripheral Psoriatic Arthritis according to the CASPAR criteria or with axial Psoriatic Arthritis according to ASAS criteria and with at least one of the following:
1. With active peripheral Psoriatic Arthritis regarding ongoing therapy in one of the following sites: MCP joints 1-5, proximal interphalangeal (PIP) joints of hands 1-5, distal interphalangeal (DIP) joints of hands 2-5, wrists, elbows, knees and ankles/heels and feet, according to any of the following criteria:
I) DAPSA ≥ 15 and joint inflammation according to the Global OMERACT-EULAR US scoring for synovitis and power Doppler (GLOESS) with a grade at patient level \>3,2
II) With a clinical enthesitis and an active enthesitis (positive power Doppler of any grade), in the clinical symptomatic site, according to the OMERACT US definitions
III) With active dactylitis (clinical diagnosis made by the physician at the time of baseline visit) and a positive US dactylitis according to the DACTylitis glObal Sonographic (DACTOS) score \>3
IV) DAPSA ≥ 15 and tenosynovitis according to the OMERACT US scoring system for tenosynovitis with a grade \>1
2. With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and active sacroiliitis according to the ASAS MRI definitions
2. Who are eligible according to the current guidelines/regulations to start treatment with UPA and present a favorable risk/benefit profile according to the clinician's opinion for such treatment.
3. Aged older than 18 years.
4. Able to provide informed consent, according to requirements of local IRB/ethics committee.
The inclusion criteria for Rheumatoid Arthritis patients are:
1. Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria
2. With active Rheumatoid Arthritis according to the following criteria: DAS28-PCR \>3.2, and the presence of at least one US finding of the following:
1. Joint inflammation at hands and wrists according to the Global OMERACT-EULAR (GLOESS) US scoring for synovitis and power Doppler with a grade at patient level \>2
2. One tenosynovitis at hands or wrists, according to the OMERACT US scoring system for tenosynovitis with a grade \>1
3. Who are eligible according to the current guidelines/regulations to start treatment with Upadacitinib and present a favourable risk/benefit profile according to the clinician's opinion for such treatment.
4. Aged older than 18 years.
5. Able to provide informed consent, according to requirements of local IRB/ethics committee.
Exclusion Criteria:
1. Patients with any contraindication to Upadacitinib:
1. women who are pregnant or breastfeeding
2. active infection
3. evidence of tuberculosis infection
4. known infection with human immunodeficiency virus or hepatitis B or C
5. patients who have current malignancy or history of malignancy in the last 5 years
6. high cardiovascular risk
7. high risk of venous thromboembolism
8. patients with severe hepatic impairment
2. Patients with associated fibromyalgia syndrome according to the 2016 ACR diagnostic criteria
3. Unable to provide informed consent, according to requirements of local IRB/ethics committee.
Where this trial is running
Legnano, Milano and 13 other locations
- Ospedale Civile di Legnano — Legnano, Milano, Italy (Recruiting)
- IRCCS Ospedale Humanitas — Rozzano, Milano, Italy (Recruiting)
- IRCCS Policlinico San Donato — San Donato, Milano, Italy (Recruiting)
- IRCCS Ospedale Galeazzi-Sant'Ambrogio, — Milan, Mi, Italy (Recruiting)
- IRCCS San Gerardo — Monza, Monza E Brianza, Italy (Recruiting)
- ASST Papa Giovanni XXIII — Bergamo, Italy (Recruiting)
- ASST Spedali Civili — Brescia, Italy (Recruiting)
- ASST Gaetano Pini CTO — Milan, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
- ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (Recruiting)
- ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco — Milan, Italy (Recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
- IRCCS Istituti Clinici Scientifici Maugeri — Pavia, Italy (Recruiting)
- ASST Settelaghi - Ospedale di Circolo di Varese — Varese, Italy (Recruiting)
Study contacts
- Principal investigator: Georgios Filippou, MD — Università degli Studi di Milano / IRCCS Ospedale Galeazzi-Sant'Ambrogio
- Study coordinator: Georgios Filippou, MD
- Email: georgios.filippou@grupposandonato.it
- Phone: 0039 0283502707
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.