Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.

Recruiting

• Conditions: Rheumatoid Arthritis (RA; Psoriatic Arthritis (PsA
• Interventions: Drug: Upadacitinib 15 MG [Rinvoq]

• Registration Number: NCT06630715
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Brief Summary

The general objective of the OPTIMA study is to assess the time course and interrelationship of imaging (ultrasound and magnetic resonance imaging), clinical, laboratory, and Patient Reported Outcome variables in patients with active Psoriatic Arthritis (any subset) and Rheumatoid Arthritis starting therapy with a Jak-Inhibitor (Upadacitinib), during the first 6 months of follow-up.

Participants will be evaluated at the start of therapy with upadacitinib and during the follow-up visits at 2 weeks, 1, 3, and 6 months post-treatment initiation. At each visit (with the exception of the 2-weeks visit), data relating to the clinical evaluation, laboratory tests, and ultrasound of the affected joints will be collected according to standard clinical practice; questionnaires on disease activity will also be completed. In the case of axial involvement, a magnetic resonance imaging will be performed at baseline and after 6 months of therapy, only if required by the standard of care.

Detailed Description

This is a multicentric prospective observational study in which consecutive patients diagnosed with Psoriatic Arthritis (any subset) and Rheumatoid Arthritis, that according to clinicians' evaluation should be treated with Upadacitinib therapy, will be recruited from the outpatient clinic of the Rheumatology Department of the centers included in the study.

The investigators will enroll consecutive patients with Psoriatic Arthritis and Rheumatoid Arthritis with active disease and fulfilling the inclusion and exclusion criteria, from the outpatient clinic of the Rheumatology Units of the participating centers. Written informed consent will be obtained prior to the beginning of the study. All patients, in line with clinical routine practice, will undergo a standard clinical, laboratory, and imaging assessment in order to define the disease activity according to standardized disease activity indexes, at baseline and during the first 3 follow-up visits. For patients starting new treatments for Psoriatic Arthritis and Rheumatoid Arthritis, the follow-up visits are generally scheduled after 1 month (± 1 week), 3 months (± 2 weeks), and 6 months (± 4 weeks) post-treatment initiation, in accordance with international guidelines and local protocols. In case of suspicion of axial involvement, an MRI of the sacroiliac joints will be performed at baseline and, in case of positivity, will be repeated after 6 months (±1 month) in order to assess disease activity at the spine and the treatment efficacy. Regarding the Patient Reported Outcome, the investigators will assess these during the scheduled visits, and two weeks after the initiation of treatment to evaluate earlier pain and functional improvement. The Patient Reported Outcome assessment at two weeks will be administered in a paper form to participants during the baseline visit, and subsequently participants will return these during the first follow-up visit. The data for the study will be retrieved from the medical records of participants and recorded into an appositely created electronic case report form.

Study Timeline

• Study Start: 2024-07-23
• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-08
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid Arthritis	Upadacitinib 15 MG [Rinvoq]	Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria with active disease starting Upadacitinib
Psoriatic Arthritis	Upadacitinib 15 MG [Rinvoq]	Patients diagnosed with peripheral Psoriatic Arthritis according to the CASPAR criteria or with axial Psoriatic Arthritis according to ASAS criteria with active disease starting Upadacitinib

Primary Outcome Measures

Name	Time	Method
Difference between US synovitis score	from baseline to 24 weeks	Difference between US synovitis score from baseline to 24 weeks in patients with active synovitis

Secondary Outcome Measures

Name	Time	Method
Difference between US dactylitis score	from baseline to 24 weeks	Difference between US dactylitis score (DACTOS) from baseline to 24 weeks in patients with active dactylitis
Difference between US tenosynovitis score	from baseline to 24 weeks	Difference between US tenosynovitis score from baseline to 24 weeks in patients with active tenosynovitis
Difference between US enthesitis score	from baseline to 24 weeks	Difference between US enthesitis score from baseline to 24 weeks in patients with active enthesitis
Difference between US peritendonitis score	from baseline to 24 weeks	Difference between US peritendonitis score from baseline to 24 weeks in patients with peritendonitis
Difference between SPARCC MRI index	from baseline to 24 weeks	Difference between SPARCC MRI index from baseline to 24 weeks in patients with active sacroiliitis in PsA
Difference between T2 mapping scores	from baseline to 24 weeks	Difference between T2 mapping scores from baseline to 24 weeks in patients with active sacroiliitis in PsA
Difference between SJC66	from baseline to 24 weeks	Difference between SJC66 from baseline to 24 weeks in PsA and RA
Difference between TJC68	from baseline to 24 weeks	Difference between TJC68 from baseline to 24 weeks in PsA and RA
Difference between the SPARCC score	from baseline to and 24 weeks	Difference between the SPARCC score from baseline to and 24 weeks in PsA
Difference between the dactylitis count	from baseline to 24 weeks	Difference between the dactylitis count from baseline to and 24 weeks in PsA
Prevalence of BSA = 0	after 24 weeks	Prevalence of BSA = 0 after 24 weeks in PsA
Difference between CRP levels	from baseline to and 24 weeks	Difference between CRP levels from baseline to and 24 weeks in PsA and RA
Difference between HAQ score	from baseline to and 24 weeks	Difference between HAQ score from baseline to and 24 weeks in PsA and RA
Difference between Physician's Global Assessment of Disease Activity VAS	from baseline to and 24 weeks	Difference between Physician's Global Assessment of Disease Activity VAS from baseline to and 24 weeks in PsA and RA
Difference between VAS pain	from baseline to and 24 weeks	Difference between VAS pain from baseline to and 24 weeks in PsA and RA
Difference between GH-VAS	from baseline to 24 weeks	Difference between GH-VAS from baseline to and 24 weeks in PsA and RA
Difference between ASDAS levels	from baseline to 24 weeks	Difference between ASDAS levels from baseline to and 24 weeks in PsA
Prevalence of MDA	at 24 weeks	Prevalence of MDA at 24 weeks in PsA
Difference between DAS28 levels	baseline and 24 weeks	Difference between DAS28 levels at baseline and 24 weeks in PsA and RA
Time to remission	up to 2 weeks	Time to remission in PsA and RA up to 2 weeks
Adverse events	from baseline and 24 weeks	Adverse events from baseline and 24 weeks

Trial Locations

Locations (14)

Ospedale Civile di Legnano; 🇮🇹 LegNano, Milano, Italy

IRCCS Ospedale Humanitas; 🇮🇹 Rozzano, Milano, Italy

IRCCS Policlinico San Donato; 🇮🇹 San Donato, Milano, Italy

IRCCS Ospedale Galeazzi-Sant'Ambrogio,; 🇮🇹 Milano, Mi, Italy

IRCCS San Gerardo; 🇮🇹 Monza, Monza E Brianza, Italy

ASST Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

ASST Spedali Civili; 🇮🇹 Brescia, Italy

ASST Gaetano Pini CTO; 🇮🇹 Milano, Italy

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italy

ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco; 🇮🇹 Milano, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

IRCCS Istituti Clinici Scientifici Maugeri; 🇮🇹 Pavia, Italy

ASST Settelaghi - Ospedale di Circolo di Varese; 🇮🇹 Varese, Italy