Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis. (OPTIMA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriatic Arthritis (PsA; Rheumatoid Arthritis (RA
• Intervention / Treatment: Drug: Upadacitinib 15 MG [Rinvoq]

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 Type: Observational
• Enrollment (Estimated): 178

Contacts and Locations

• Study Contact: Name: Georgios Filippou, MD; Phone Number: 0039 0283502707; Email: georgios.filippou@grupposandonato.it
• Study Contact Backup: Name: Silvia Sirotti, MD; Phone Number: 0039 0283502708; Email: silvia.sirotti@grupposandonato.it

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • Recruiting
    • ASST Papa Giovanni XXIII
    • Contact: Eleonora Bruschi, MD; Phone Number: 0039 035267111; Email: eleonorabruschi@virgilio.it
    • Principal Investigator: Eleonora Bruschi, MD
  • Brescia, Italy, 25153
    • Recruiting
    • ASST Spedali Civili
    • Contact: Matteo Filippini, MD; Phone Number: 0039 03039951; Email: matteofilippini@icloud.com
    • Principal Investigator: Matteo Filippini, MD
  • Milano, Italy, 20132
    • Recruiting
    • Irccs Ospedale San Raffaele
    • Contact: Nicola Boffini, MD; Phone Number: 0039 0226431; Email: boffini.nicola@hsr.it
    • Principal Investigator: Nicola Boffini, MD
  • Milano, Italy, 20162
    • Recruiting
    • ASST Grande Ospedale Metropolitano Niguarda
    • Contact: Oscar Massimiliano Epis, MD; Phone Number: 0039 0264441; Email: oscar.epis@ospedaleniguarda.it
    • Principal Investigator: Oscar Massimiliano Epis, MD
    • Sub-Investigator: Antonella Adinolfi, MD
  • Milano, Italy, 20122
    • Recruiting
    • ASST Gaetano Pini CTO
    • Contact: Orazio De Lucia; Phone Number: 0039 02582961; Email: oraziodelucia@alice.it
    • Principal Investigator: Orazio De Lucia
  • Milano, Italy
    • Recruiting
    • ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco
    • Contact: Bruno Lucchino, MD; Phone Number: 0039 0239041; Email: lucchino.bruno@asst-fbf-sacco.it
    • Principal Investigator: Bruno Lucchino, MD
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
    • Contact: Ludovico De Stefano, MD; Phone Number: 0039 03825011; Email: ludovico.destefano01@universitadipavia.it
    • Sub-Investigator: Ludovico De Stefano, MD
  • Pavia, Italy, 27100
    • Recruiting
    • IRCCS Istituti Clinici Scientifici Maugeri
    • Contact: Garifallia Sakellariou, MD; Phone Number: 0039 03825921; Email: filiciasak@gmail.com
    • Principal Investigator: Garifallia Sakellariou, MD
  • Varese, Italy, 21100
    • Recruiting
    • ASST Settelaghi - Ospedale di Circolo di Varese
    • Contact: Alberto Batticciotto, MD; Phone Number: 0039 0332 278111; Email: alberto.batticciotto@asst-settelaghi.it
    • Principal Investigator: Alberto Batticciotto,, MD
  • Mi
    • Milano, Mi, Italy, 20157
      • Recruiting
      • IRCCS Ospedale Galeazzi-Sant'Ambrogio,
      • Contact: Georgios Filippou, MD; Phone Number: 0039 0283532707; Email: georgios.filippou@grupposandonato.it
      • Principal Investigator: Georgios Filippou, MD
      • Sub-Investigator: Silvia Sirotti, MD
      • Sub-Investigator: Luca Maria Sconfienza, MD
  • Milano
    • LegNano, Milano, Italy, 20025
      • Recruiting
      • Ospedale Civile di Legnano
      • Contact: Laura Castelnovo, MD; Phone Number: 0039 0331449111; Email: laura.castelnovo@asst-ovestmi.it
      • Principal Investigator: Laura Castelnovo, MD
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • IRCCS Ospedale Humanitas
      • Contact: Marta Caprioli, MD; Phone Number: 0039 0282241; Email: marta.caprioli78@gmail.com
      • Principal Investigator: Marta Caprioli, MD
    • San Donato, Milano, Italy, 20097
      • Recruiting
      • IRCCS Policlinico San Donato
      • Contact: Nikoleta Vaso, MD; Phone Number: 0039 02527741; Email: nikoleta.vaso@grupposandonato.it
      • Principal Investigator: Nikoleta Vaso, MD
  • Monza E Brianza
    • Monza, Monza E Brianza, Italy, 20900
      • Recruiting
      • IRCCS San Gerardo
      • Contact: Carlo Alberto Scirè, MD; Phone Number: 0039 0392331; Email: carlo.scire@unimib.it
      • Sub-Investigator: Carlo Alberto Scirè, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rheumatoid Arthritis; Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria with active disease starting Upadacitinib	Drug: Upadacitinib 15 MG [Rinvoq]; 15 mg/ day
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]; 15 mg/ day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
• Investigators: Principal Investigator: Georgios Filippou, MD, Università degli Studi di Milano / IRCCS Ospedale Galeazzi-Sant'Ambrogio

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Ultrasound; Psoriatic Arthritis; Upadacitinib; Synovitis; sacroiliitis; Enthesitis; rheumathoid Arthritis; Dactylitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; Janus Kinase Inhibitors; Upadacitinib
• Other Study ID Numbers: OPTIMA (L4182)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No