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

NCT06630715 | Recruiting

• 1 other identifier: OPTIMA (L4182)
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 14

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.

Conditions

Rheumatoid Arthritis (RA; Psoriatic Arthritis (PsA

Keywords

rheumathoid Arthritis; Psoriatic Arthritis; Ultrasound; MRI; Upadacitinib; Dactylitis; Enthesitis; Synovitis; sacroiliitis

Outcome Measures

Primary Outcomes (1)

• Difference between US synovitis score

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

  from baseline to 24 weeks

Secondary Outcomes (21)

• Difference between US dactylitis score

  from baseline to 24 weeks

• Difference between US tenosynovitis score

  from baseline to 24 weeks

• Difference between US enthesitis score

  from baseline to 24 weeks

• Difference between US peritendonitis score

  from baseline to 24 weeks

• Difference between SPARCC MRI index

  from baseline to 24 weeks

Study Arms (2)

Rheumatoid Arthritis

Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria with active disease starting Upadacitinib

Drug: Upadacitinib 15 MG [Rinvoq]

Psoriatic Arthritis

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

Drug: Upadacitinib 15 MG [Rinvoq]

Interventions

Upadacitinib 15 MG [Rinvoq] DRUG

15 mg/ day

Psoriatic Arthritis; Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with active Psoriatic Arthritis and patients with active Rheumatoid Arthritis who will start therapy with upadacitinib

You may qualify if:

• 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:
• 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
• With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and active sacroiliitis according to the ASAS MRI definitions
• 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.
• Aged older than 18 years.
• Able to provide informed consent, according to requirements of local IRB/ethics committee.
• Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria
• 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:
• 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
• One tenosynovitis at hands or wrists, according to the OMERACT US scoring system for tenosynovitis with a grade \>1
• 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.

You may not qualify if:

• Patients with any contraindication to Upadacitinib:
• women who are pregnant or breastfeeding
• active infection
• evidence of tuberculosis infection
• known infection with human immunodeficiency virus or hepatitis B or C
• patients who have current malignancy or history of malignancy in the last 5 years
• high cardiovascular risk
• high risk of venous thromboembolism
• patients with severe hepatic impairment
• Patients with associated fibromyalgia syndrome according to the 2016 ACR diagnostic criteria
• Unable to provide informed consent, according to requirements of local IRB/ethics committee.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (14)

Ospedale Civile di Legnano

Legnano, Milano, 20025, Italy

RECRUITING

IRCCS Ospedale Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

IRCCS Policlinico San Donato

San Donato, Milano, 20097, Italy

RECRUITING

IRCCS Ospedale Galeazzi-Sant'Ambrogio,

Milan, Mi, 20157, Italy

RECRUITING

IRCCS San Gerardo

Monza, Monza E Brianza, 20900, Italy

RECRUITING

ASST Papa Giovanni XXIII

Bergamo, 24127, Italy

RECRUITING

ASST Spedali Civili

Brescia, 25153, Italy

RECRUITING

ASST Gaetano Pini CTO

Milan, 20122, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

RECRUITING

ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco

Milan, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, 27100, Italy

RECRUITING

ASST Settelaghi - Ospedale di Circolo di Varese

Varese, 21100, Italy

RECRUITING

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MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Salivary Gland Adenoma, Pleomorphic; Synovitis; Sacroiliitis

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Georgios Filippou, MD

  Università degli Studi di Milano / IRCCS Ospedale Galeazzi-Sant'Ambrogio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios Filippou, MD

CONTACT

0039 0283502707; georgios.filippou@grupposandonato.it

Silvia Sirotti, MD

CONTACT

0039 0283502708; silvia.sirotti@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 8, 2024
• Study Start: July 23, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-09

Locations

IT (14)