Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.
NCT ID: NCT06630715
Last Updated: 2024-10-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
178 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-07-23
Study Completion Date
2025-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Rheumatoid Arthritis (RA
Psoriatic Arthritis (PsA
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Rheumatoid Arthritis
Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria with active disease starting Upadacitinib
Upadacitinib 15 MG [Rinvoq]
Intervention Type
DRUG
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
Upadacitinib 15 MG [Rinvoq]
Intervention Type
DRUG
15 mg/ day
Interventions
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Upadacitinib 15 MG [Rinvoq]
15 mg/ day
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
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.
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.
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.
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Georgios Filippou, MD
Role: PRINCIPAL_INVESTIGATOR
Università degli Studi di Milano / IRCCS Ospedale Galeazzi-Sant'Ambrogio
Locations
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Ospedale Civile di Legnano
Legnano, Milano, Italy
Site Status
RECRUITING
IRCCS Ospedale Humanitas
Rozzano, Milano, Italy
Site Status
RECRUITING
IRCCS Policlinico San Donato
San Donato, Milano, Italy
Site Status
RECRUITING
IRCCS Ospedale Galeazzi-Sant'Ambrogio,
Milan, Mi, Italy
Site Status
RECRUITING
IRCCS San Gerardo
Monza, Monza E Brianza, Italy
Site Status
RECRUITING
ASST Papa Giovanni XXIII
Bergamo, , Italy
Site Status
RECRUITING
ASST Spedali Civili
Brescia, , Italy
Site Status
RECRUITING
ASST Gaetano Pini CTO
Milan, , Italy
Site Status
RECRUITING
IRCCS Ospedale San Raffaele
Milan, , Italy
Site Status
RECRUITING
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Site Status
RECRUITING
ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco
Milan, , Italy
Site Status
RECRUITING
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Site Status
RECRUITING
IRCCS Istituti Clinici Scientifici Maugeri
Pavia, , Italy
Site Status
RECRUITING
ASST Settelaghi - Ospedale di Circolo di Varese
Varese, , Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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References
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Balint PV, Terslev L, Aegerter P, Bruyn GAW, Chary-Valckenaere I, Gandjbakhch F, Iagnocco A, Jousse-Joulin S, Moller I, Naredo E, Schmidt WA, Wakefield RJ, D'Agostino MA; OMERACT Ultrasound Task Force members. Reliability of a consensus-based ultrasound definition and scoring for enthesitis in spondyloarthritis and psoriatic arthritis: an OMERACT US initiative. Ann Rheum Dis. 2018 Dec;77(12):1730-1735. doi: 10.1136/annrheumdis-2018-213609. Epub 2018 Aug 3.
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D'Agostino MA, Terslev L, Aegerter P, Backhaus M, Balint P, Bruyn GA, Filippucci E, Grassi W, Iagnocco A, Jousse-Joulin S, Kane D, Naredo E, Schmidt W, Szkudlarek M, Conaghan PG, Wakefield RJ. Scoring ultrasound synovitis in rheumatoid arthritis: a EULAR-OMERACT ultrasound taskforce-Part 1: definition and development of a standardised, consensus-based scoring system. RMD Open. 2017 Jul 11;3(1):e000428. doi: 10.1136/rmdopen-2016-000428. eCollection 2017.
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Schoels MM, Aletaha D, Alasti F, Smolen JS. Disease activity in psoriatic arthritis (PsA): defining remission and treatment success using the DAPSA score. Ann Rheum Dis. 2016 May;75(5):811-8. doi: 10.1136/annrheumdis-2015-207507. Epub 2015 Aug 12.
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Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.
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Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006 Aug;54(8):2665-73. doi: 10.1002/art.21972.
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Mease P, Setty A, Papp K, Van den Bosch F, Tsuji S, Keiserman M, Carter K, Li Y, McCaskill R, McDearmon-Blondell E, Wung P, Tillett W. Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study. Clin Exp Rheumatol. 2023 Nov;41(11):2286-2297. doi: 10.55563/clinexprheumatol/8l7bbk. Epub 2023 Jul 5.
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BACKGROUND
Gossec L, Baraliakos X, Kerschbaumer A, de Wit M, McInnes I, Dougados M, Primdahl J, McGonagle DG, Aletaha D, Balanescu A, Balint PV, Bertheussen H, Boehncke WH, Burmester GR, Canete JD, Damjanov NS, Kragstrup TW, Kvien TK, Landewe RBM, Lories RJU, Marzo-Ortega H, Poddubnyy D, Rodrigues Manica SA, Schett G, Veale DJ, Van den Bosch FE, van der Heijde D, Smolen JS. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):700-712. doi: 10.1136/annrheumdis-2020-217159.
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Celis R, Cuervo A, Ramirez J, Canete JD. Psoriatic Synovitis: Singularity and Potential Clinical Implications. Front Med (Lausanne). 2019 Feb 11;6:14. doi: 10.3389/fmed.2019.00014. eCollection 2019.
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McGonagle D, Lories RJ, Tan AL, Benjamin M. The concept of a "synovio-entheseal complex" and its implications for understanding joint inflammation and damage in psoriatic arthritis and beyond. Arthritis Rheum. 2007 Aug;56(8):2482-91. doi: 10.1002/art.22758. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OPTIMA (L4182)
Identifier Type: -
Identifier Source: org_study_id
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