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Rheumatoid Arthritis (RAOPTIMANCT06630715

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

An observational study of Rheumatoid Arthritis (RA and Psoriatic Arthritis (PsA, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 14 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Upadacitinib 15 MG [Rinvoq]
How many people
178 participants
Where
14 sitesItaly
Study dates
23 Jul 2024to Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country.

Georgios Filippou, MD contact

0039 0283502707

georgios.filippou@grupposandonato.it

Silvia Sirotti, MD contact

0039 0283502708

silvia.sirotti@grupposandonato.it

14 sites in 1 country

Italy14 sites, 14 recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, 24127

    Eleonora Bruschi, MD, 0039 035267111, eleonorabruschi@virgilio.it

    Eleonora Bruschi, MD

    Recruiting

  • ASST Spedali Civili

    Brescia, 25153

    Matteo Filippini, MD, 0039 03039951, matteofilippini@icloud.com

    Matteo Filippini, MD

    Recruiting

  • Ospedale Civile di Legnano

    Legnano, Milano, 20025

    Laura Castelnovo, MD, 0039 0331449111, laura.castelnovo@asst-ovestmi.it

    Laura Castelnovo, MD

    Recruiting

  • IRCCS Ospedale Galeazzi-Sant'Ambrogio,

    Milan, Mi, 20157

    Georgios Filippou, MD, 0039 0283532707, georgios.filippou@grupposandonato.it

    Georgios Filippou, MD

    Recruiting

  • ASST Gaetano Pini CTO

    Milan, 20122

    Orazio De Lucia, 0039 02582961, oraziodelucia@alice.it

    Orazio De Lucia

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Nicola Boffini, MD, 0039 0226431, boffini.nicola@hsr.it

    Nicola Boffini, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Oscar Massimiliano Epis, MD, 0039 0264441, oscar.epis@ospedaleniguarda.it

    Oscar Massimiliano Epis, MD

    Recruiting

  • ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco

    Milan

    Bruno Lucchino, MD, 0039 0239041, lucchino.bruno@asst-fbf-sacco.it

    Bruno Lucchino, MD

    Recruiting

  • IRCCS San Gerardo

    Monza, Monza E Brianza, 20900

    Carlo Alberto Scirè, MD, 0039 0392331, carlo.scire@unimib.it

    Carlo Alberto Scirè, MD

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Ludovico De Stefano, MD, 0039 03825011, ludovico.destefano01@universitadipavia.it

    Ludovico De Stefano, MD

    Recruiting

  • IRCCS Istituti Clinici Scientifici Maugeri

    Pavia, 27100

    Garifallia Sakellariou, MD, 0039 03825921, filiciasak@gmail.com

    Garifallia Sakellariou, MD

    Recruiting

  • IRCCS Ospedale Humanitas

    Rozzano, Milano, 20089

    Marta Caprioli, MD, 0039 0282241, marta.caprioli78@gmail.com

    Marta Caprioli, MD

    Recruiting

  • IRCCS Policlinico San Donato

    San Donato, Milano, 20097

    Nikoleta Vaso, MD, 0039 02527741, nikoleta.vaso@grupposandonato.it

    Nikoleta Vaso, MD

    Recruiting

  • ASST Settelaghi - Ospedale di Circolo di Varese

    Varese, 21100

    Alberto Batticciotto, MD, 0039 0332 278111, alberto.batticciotto@asst-settelaghi.it

    Alberto Batticciotto,, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Upadacitinib 15 MG [Rinvoq]
Keywords
rheumathoid Arthritis, Psoriatic Arthritis, Ultrasound, MRI, Upadacitinib, Dactylitis, Enthesitis, Synovitis, sacroiliitis
Medical subject headings
Arthritis, Rheumatoid, Arthritis, Psoriatic, Salivary Gland Adenoma, Pleomorphic, Synovitis, Sacroiliitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Upadacitinib 15 MG [Rinvoq]Drug

    15 mg/ day

Study groups in NCT06630715
Study groupRoleWhat they receive
Rheumatoid ArthritisPatients diagnosed with RA according to the ACR/EULAR 2010 classification criteria with active disease starting Upadacitinib
Receives: Drug: Upadacitinib 15 MG [Rinvoq]
Psoriatic ArthritisPatients diagnosed with peripheral Psoriatic Arthritis according to the CASPAR criteria or with axial Psoriatic Arthritis according to ASAS criteria with active disease starting Upadacitinib
Receives: Drug: Upadacitinib 15 MG [Rinvoq]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference between US synovitis score

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

    Measured: from baseline to 24 weeks

Secondary outcomes (21)

  1. Difference between US dactylitis score

    Difference between US dactylitis score (DACTOS) from baseline to 24 weeks in patients with active dactylitis

    Measured: from baseline to 24 weeks

  2. Difference between US tenosynovitis score

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

    Measured: from baseline to 24 weeks

  3. Difference between US enthesitis score

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

    Measured: from baseline to 24 weeks

  4. Difference between US peritendonitis score

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

    Measured: from baseline to 24 weeks

  5. Difference between SPARCC MRI index

    Difference between SPARCC MRI index from baseline to 24 weeks in patients with active sacroiliitis in PsA

    Measured: from baseline to 24 weeks

  6. Difference between T2 mapping scores

    Difference between T2 mapping scores from baseline to 24 weeks in patients with active sacroiliitis in PsA

    Measured: from baseline to 24 weeks

  7. Difference between SJC66

    Difference between SJC66 from baseline to 24 weeks in PsA and RA

    Measured: from baseline to 24 weeks

  8. Difference between TJC68

    Difference between TJC68 from baseline to 24 weeks in PsA and RA

    Measured: from baseline to 24 weeks

  9. Difference between the SPARCC score

    Difference between the SPARCC score from baseline to and 24 weeks in PsA

    Measured: from baseline to and 24 weeks

  10. Difference between the dactylitis count

    Difference between the dactylitis count from baseline to and 24 weeks in PsA

    Measured: from baseline to 24 weeks

  11. Prevalence of BSA = 0

    Prevalence of BSA = 0 after 24 weeks in PsA

    Measured: after 24 weeks

  12. Difference between CRP levels

    Difference between CRP levels from baseline to and 24 weeks in PsA and RA

    Measured: from baseline to and 24 weeks

  13. Difference between HAQ score

    Difference between HAQ score from baseline to and 24 weeks in PsA and RA

    Measured: from baseline to and 24 weeks

  14. 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

    Measured: from baseline to and 24 weeks

  15. Difference between VAS pain

    Difference between VAS pain from baseline to and 24 weeks in PsA and RA

    Measured: from baseline to and 24 weeks

  16. Difference between GH-VAS

    Difference between GH-VAS from baseline to and 24 weeks in PsA and RA

    Measured: from baseline to 24 weeks

  17. Difference between ASDAS levels

    Difference between ASDAS levels from baseline to and 24 weeks in PsA

    Measured: from baseline to 24 weeks

  18. Prevalence of MDA

    Prevalence of MDA at 24 weeks in PsA

    Measured: at 24 weeks

  19. Difference between DAS28 levels

    Difference between DAS28 levels at baseline and 24 weeks in PsA and RA

    Measured: baseline and 24 weeks

  20. Time to remission

    Time to remission in PsA and RA up to 2 weeks

    Measured: up to 2 weeks

  21. Adverse events

    Adverse events from baseline and 24 weeks

    Measured: from baseline and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start23 Jul 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
178 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630715
Sponsor's protocol ID
OPTIMA (L4182)
Acronym
OPTIMA
Status last verified
Sep 2024
First submitted
25 Sep 2024
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Albano D, Bignone R, Chianca V, Cuocolo R, Messina C, Sconfienza LM, Ciccia F, Brunetti A, Midiri M, Galia M. T2 mapping of the sacroiliac joints in patients with axial spondyloarthritis. Eur J Radiol. 2020 Oct;131:109246. doi: 10.1016/j.ejrad.2020.109246. Epub 2020 Aug 29.

    PubMed 32911127

  • Maksymowych WP, Inman RD, Salonen D, Dhillon SS, Williams M, Stone M, Conner-Spady B, Palsat J, Lambert RG. Spondyloarthritis research Consortium of Canada magnetic resonance imaging index for assessment of sacroiliac joint inflammation in ankylosing spondylitis. Arthritis Rheum. 2005 Oct 15;53(5):703-9. doi: 10.1002/art.21445.

    PubMed 16208659

  • Lambert RG, Bakker PA, van der Heijde D, Weber U, Rudwaleit M, Hermann KG, Sieper J, Baraliakos X, Bennett A, Braun J, Burgos-Vargas R, Dougados M, Pedersen SJ, Jurik AG, Maksymowych WP, Marzo-Ortega H, Ostergaard M, Poddubnyy D, Reijnierse M, van den Bosch F, van der Horst-Bruinsma I, Landewe R. Defining active sacroiliitis on MRI for classification of axial spondyloarthritis: update by the ASAS MRI working group. Ann Rheum Dis. 2016 Nov;75(11):1958-1963. doi: 10.1136/annrheumdis-2015-208642. Epub 2016 Jan 14.

    PubMed 26768408

  • Sudol-Szopinska I, Jurik AG, Eshed I, Lennart J, Grainger A, Ostergaard M, Klauser A, Cotten A, Wick MC, Maas M, Miese F, Egund N, Boutry N, Rupreht M, Reijnierse M, Oei EH, Meier R, O'Connor P, Feydy A, Mascarenhas V, Plagou A, Simoni P, Platzgummer H, Rennie WJ, Mester A, Teh J, Robinson P, Guglielmi G, Astrom G, Schueller-Weiderkamm C. Recommendations of the ESSR Arthritis Subcommittee for the Use of Magnetic Resonance Imaging in Musculoskeletal Rheumatic Diseases. Semin Musculoskelet Radiol. 2015 Sep;19(4):396-411. doi: 10.1055/s-0035-1564696. Epub 2015 Nov 19.

    PubMed 26583367

  • Torp-Pedersen S, Christensen R, Szkudlarek M, Ellegaard K, D'Agostino MA, Iagnocco A, Naredo E, Balint P, Wakefield RJ, Torp-Pedersen A, Terslev L. Power and color Doppler ultrasound settings for inflammatory flow: impact on scoring of disease activity in patients with rheumatoid arthritis. Arthritis Rheumatol. 2015 Feb;67(2):386-95. doi: 10.1002/art.38940.

    PubMed 25370843

  • Moller I, Janta I, Backhaus M, Ohrndorf S, Bong DA, Martinoli C, Filippucci E, Sconfienza LM, Terslev L, Damjanov N, Hammer HB, Sudol-Szopinska I, Grassi W, Balint P, Bruyn GAW, D'Agostino MA, Hollander D, Siddle HJ, Supp G, Schmidt WA, Iagnocco A, Koski J, Kane D, Fodor D, Bruns A, Mandl P, Kaeley GS, Micu M, Ho C, Vlad V, Chavez-Lopez M, Filippou G, Ceron CE, Nestorova R, Quintero M, Wakefield R, Carmona L, Naredo E. The 2017 EULAR standardised procedures for ultrasound imaging in rheumatology. Ann Rheum Dis. 2017 Dec;76(12):1974-1979. doi: 10.1136/annrheumdis-2017-211585. Epub 2017 Aug 16.

    PubMed 28814430

  • Gutierrez M, Filippucci E, Salaffi F, Di Geso L, Grassi W. Differential diagnosis between rheumatoid arthritis and psoriatic arthritis: the value of ultrasound findings at metacarpophalangeal joints level. Ann Rheum Dis. 2011 Jun;70(6):1111-4. doi: 10.1136/ard.2010.147272. Epub 2011 Mar 15.

    PubMed 21406459

  • Moon SJ, Lee WY, Hwang JS, Hong YP, Morisky DE. Accuracy of a screening tool for medication adherence: A systematic review and meta-analysis of the Morisky Medication Adherence Scale-8. PLoS One. 2017 Nov 2;12(11):e0187139. doi: 10.1371/journal.pone.0187139. eCollection 2017.

    PubMed 29095870

  • Horta-Baas G. Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake? Patient Relat Outcome Meas. 2022 Mar 30;13:79-95. doi: 10.2147/PROM.S256715. eCollection 2022.

    PubMed 35388274

  • Oji V, Luger TA. The skin in psoriasis: assessment and challenges. Clin Exp Rheumatol. 2015 Sep-Oct;33(5 Suppl 93):S14-9. Epub 2015 Oct 15.

    PubMed 26472560

  • Maksymowych WP, Mallon C, Morrow S, Shojania K, Olszynski WP, Wong RL, Sampalis J, Conner-Spady B. Development and validation of the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index. Ann Rheum Dis. 2009 Jun;68(6):948-53. doi: 10.1136/ard.2007.084244. Epub 2008 Jun 4.

    PubMed 18524792

  • Duarte-Garcia A, Leung YY, Coates LC, Beaton D, Christensen R, Craig ET, de Wit M, Eder L, Fallon L, FitzGerald O, Gladman DD, Goel N, Holland R, Lindsay C, Maxwell L, Mease P, Orbai AM, Shea B, Strand V, Veale DJ, Tillett W, Ogdie A. Endorsement of the 66/68 Joint Count for the Measurement of Musculoskeletal Disease Activity: OMERACT 2018 Psoriatic Arthritis Workshop Report. J Rheumatol. 2019 Aug;46(8):996-1005. doi: 10.3899/jrheum.181089. Epub 2019 Feb 15.

    PubMed 30770518

  • Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, Baraliakos X, Landewe RBM, Van den Bosch FE, Boteva B, Bremander A, Carron P, Ciurea A, van Gaalen FA, Geher P, Gensler L, Hermann J, de Hooge M, Husakova M, Kiltz U, Lopez-Medina C, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compan V, Nissen MJ, Pimentel-Santos FM, Poddubnyy D, Proft F, Rudwaleit M, Telkman M, Zhao SS, Ziade N, van der Heijde D. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):19-34. doi: 10.1136/ard-2022-223296. Epub 2022 Oct 21.

    PubMed 36270658

  • Smolen JS, Landewe RBM, Bergstra SA, Kerschbaumer A, Sepriano A, Aletaha D, Caporali R, Edwards CJ, Hyrich KL, Pope JE, de Souza S, Stamm TA, Takeuchi T, Verschueren P, Winthrop KL, Balsa A, Bathon JM, Buch MH, Burmester GR, Buttgereit F, Cardiel MH, Chatzidionysiou K, Codreanu C, Cutolo M, den Broeder AA, El Aoufy K, Finckh A, Fonseca JE, Gottenberg JE, Haavardsholm EA, Iagnocco A, Lauper K, Li Z, McInnes IB, Mysler EF, Nash P, Poor G, Ristic GG, Rivellese F, Rubbert-Roth A, Schulze-Koops H, Stoilov N, Strangfeld A, van der Helm-van Mil A, van Duuren E, Vliet Vlieland TPM, Westhovens R, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):3-18. doi: 10.1136/ard-2022-223356. Epub 2022 Nov 10.

    PubMed 36357155

  • Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.2016.08.012. Epub 2016 Aug 30.

    PubMed 27916278

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis (RA and Psoriatic Arthritis (PsA, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 14 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Georgios Filippou, MD (0039 0283502707, georgios.filippou@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference between US synovitis score (time frame: from baseline to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06630715, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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