Ultrasound in Psoriatic Arthritis Treatment

NCT03330769 | Unknown

• 1 other identifier: F8MRG
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 4

Brief Summary

BACKGROUND Psoriatic arthritis (PsA) is a systemic inflammatory disease with articular and extra-articular features. Establishing the prognosis of a patient with PsA is hence important to define the treatment strategy. Currently, observational and prospective cohort studies have identified prognostic factors correlating with the achievement of therapeutic response. Nevertheless, despite the importance of identifying prognostic factors in a disease with a functional disability comparable to rheumatoid arthritis, the studies are still limited. PRIMARY OBJECTIVE In PsA with clinically active joint disease starting a new course of therapy, to evaluate the additional value of UltraSound(US)-score over clinical examination in detecting patients achieving MDA at 6 months. STUDY DESIGN The study follows a multi-centre observational prospective cohort study design. PATIENTS AND METHODS INCLUSION CRITERIA

• Adult \> 18 years of age with PsA (PsA according to the ClASsification criteria for Psoriatic Arthritis (CASPAR) - with joint involvement)
• At least one joint clinically involved (both swelling and tenderness);
• prescription of new course of d NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional Disease-Modifying AntiRheumatic Drugs (DMARDs), biologic DMARDs, including switches or dose augmentations indicated by the treating rheumatologist according to usual clinical practice before US acquisition;
• Stable treatment before treatment modification (6 weeks);
• Signed informed consent form. CLINICAL ASSESSMENT Patient's clinical assessment will be performed according to the core set of domains for PsA proposed by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT). ULTRASOUND ASSESSMENT Sonographic evaluations will be performed by expert ultrasonographers in 44 joints, 36 tendons, 12 entheses and 2 bursae according to the score developed for psoriatic arthritis by the study group ultrasound of the Italian Society of Rheumatology (US-score PsA-SIR) EXPECTED RESULTS AND SIGNIFICANCE The aim of this study is to identify clinical and US predictors of achieving MDA in PsA patients with active peripheral arthritis starting a new course of therapy.

Conditions

Arthritis, Psoriatic; Ultrasonography; Minimal Disease, Residual

Keywords

Psoriatic Arthritis; Ultrasonography; Minimal disease activity

Outcome Measures

Primary Outcomes (1)

• Minimal disease activity

  The Minimal disease activity (MDA) calculation will be based on the evaluation of 7 variables: 1. 68 tender joints count (≤1) 2. 66 swollen joint count (≤1) 3. Body Surface Area (BSA) ≤3 4. Patient pain VAS (≤15 mm); 5. Patient global disease activity VAS (≤20 mm); 6. HAQ (≤0.5); 7. Leeds Enthesitis Index (LEI) tender entheseal points (≤1) Patients will be classified as having MDA if they meet 5 out of these 7 criteria (value in brackets).

  6 months

Secondary Outcomes (7)

• Minimal disease activity

  12 months

• Disease Activity for Psoriatic Arthritis (DAPSA)

  6 and 12 months

• American College of Rheumatology (ACR) response score

  6 and 12 months

• X-ray structural progression (mSVH score)

  12 and 24 months

• Ultraosund structural progression

  12 and 24 months

Study Arms (1)

Patients with active Psoriatic Arthritis

Patients with clinically diagnosed PsA with clinically active joint disease starting a new course of treatment.

Drug: New course of treatment

Interventions

New course of treatment DRUG

Prescription of new course of NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional DMARDs, biologic DMARDs, including switches or dose augmentations, indicated by the treating rheumatologist according to usual clinical practice.

Also known as: NSAIDs, steroid intra-articular injections, Conventional DMARDs, biologic DMARDs

Patients with active Psoriatic Arthritis

Eligibility Criteria

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

Study Population

Clinically diagnosed PsA with clinically active joint disease starting a new course of therapy for active joint disease.

You may qualify if:

• Adult \> 18 years of age with PsA (according to the CASPAR classification Criteria)
• Clinically active arthritis, with at least one joint clinically involved (both swelling and tenderness) in patient not achieving the MDA;
• Subject newly prescribed NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional DMARD, biologic DMARDs as indicated by the treating rheumatologist according to usual clinical practice before US acquisition;
• Stable treatment before treatment modification (6 weeks);
• Signed informed consent form;

You may not qualify if:

• Minimal disease activity a the time of enrolment

Sponsors & Collaborators

• University of Cagliari: lead
• Italian Society for Rheumatology: collaborator
• University of Turin, Italy: collaborator
• University Hospital, Udine, Italy: collaborator
• Azienda Sanitaria Locale Roma E: collaborator

Study Sites (4)

Azienda Ospedaliera Universitaria

Cagliari, 09042, Italy

RECRUITING

Local Health Unit (ASL) Rome-1, Rome-4

Roma, Italy

RECRUITING

University of Turin

Torino, Italy

RECRUITING

University Hospital "Santa Maria della Misericordia"

Udine, Italy

RECRUITING

Related Publications (10)

• Moll JM, Wright V. Psoriatic arthritis. Semin Arthritis Rheum. 1973;3(1):55-78. doi: 10.1016/0049-0172(73)90035-8. No abstract available.

  PMID: 4581554 BACKGROUND

• Coates LC, Helliwell PS. Validation of minimal disease activity criteria for psoriatic arthritis using interventional trial data. Arthritis Care Res (Hoboken). 2010 Jul;62(7):965-9. doi: 10.1002/acr.20155.

  PMID: 20589696 BACKGROUND

• Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, Emery P, Landewe R, Oliver S, Aletaha D, Betteridge N, Braun J, Burmester G, Canete JD, Damjanov N, FitzGerald O, Haglund E, Helliwell P, Kvien TK, Lories R, Luger T, Maccarone M, Marzo-Ortega H, McGonagle D, McInnes IB, Olivieri I, Pavelka K, Schett G, Sieper J, van den Bosch F, Veale DJ, Wollenhaupt J, Zink A, van der Heijde D. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Mar;75(3):499-510. doi: 10.1136/annrheumdis-2015-208337. Epub 2015 Dec 7.

  PMID: 26644232 BACKGROUND

• Saber TP, Ng CT, Renard G, Lynch BM, Pontifex E, Walsh CA, Grier A, Molloy M, Bresnihan B, Fitzgerald O, Fearon U, Veale DJ. Remission in psoriatic arthritis: is it possible and how can it be predicted? Arthritis Res Ther. 2010;12(3):R94. doi: 10.1186/ar3021. Epub 2010 May 18.

  PMID: 20482783 BACKGROUND

• Glintborg B, Ostergaard M, Krogh NS, Andersen MD, Tarp U, Loft AG, Lindegaard HM, Holland-Fischer M, Nordin H, Jensen DV, Olsen CH, Hetland ML. Clinical response, drug survival, and predictors thereof among 548 patients with psoriatic arthritis who switched tumor necrosis factor alpha inhibitor therapy: results from the Danish Nationwide DANBIO Registry. Arthritis Rheum. 2013 May;65(5):1213-23. doi: 10.1002/art.37876.

  PMID: 23460467 BACKGROUND

• Coates LC, Moverley AR, McParland L, Brown S, Navarro-Coy N, O'Dwyer JL, Meads DM, Emery P, Conaghan PG, Helliwell PS. Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial. Lancet. 2015 Dec 19;386(10012):2489-98. doi: 10.1016/S0140-6736(15)00347-5. Epub 2015 Oct 1.

  PMID: 26433318 BACKGROUND

• Mandl P, Navarro-Compan V, Terslev L, Aegerter P, van der Heijde D, D'Agostino MA, Baraliakos X, Pedersen SJ, Jurik AG, Naredo E, Schueller-Weidekamm C, Weber U, Wick MC, Bakker PA, Filippucci E, Conaghan PG, Rudwaleit M, Schett G, Sieper J, Tarp S, Marzo-Ortega H, Ostergaard M; European League Against Rheumatism (EULAR). EULAR recommendations for the use of imaging in the diagnosis and management of spondyloarthritis in clinical practice. Ann Rheum Dis. 2015 Jul;74(7):1327-39. doi: 10.1136/annrheumdis-2014-206971. Epub 2015 Apr 2.

  PMID: 25837448 BACKGROUND

• Gladman DD, Mease PJ, Healy P, Helliwell PS, Fitzgerald O, Cauli A, Lubrano E, Krueger GG, van der Heijde D, Veale DJ, Kavanaugh A, Nash P, Ritchlin C, Taylor W, Strand V. Outcome measures in psoriatic arthritis. J Rheumatol. 2007 May;34(5):1159-66.

  PMID: 17477479 BACKGROUND

• Gladman DD, Mease PJ, Strand V, Healy P, Helliwell PS, Fitzgerald O, Gottlieb AB, Krueger GG, Nash P, Ritchlin CT, Taylor W, Adebajo A, Braun J, Cauli A, Carneiro S, Choy E, Dijkmans B, Espinoza L, van der Heijde D, Husni E, Lubrano E, McGonagle D, Qureshi A, Soriano ER, Zochling J. Consensus on a core set of domains for psoriatic arthritis. J Rheumatol. 2007 May;34(5):1167-70.

  PMID: 17477480 BACKGROUND

• Canzoni M, Piga M, Zabotti A, Scire CA, Carrara G, Olivieri I, Iagnocco A. Clinical and ultrasonographic predictors for achieving minimal disease activity in patients with psoriatic arthritis: the UPSTREAM (Ultrasound in PSoriatic arthritis TREAtMent) prospective observational study protocol. BMJ Open. 2018 Jul 10;8(7):e021942. doi: 10.1136/bmjopen-2018-021942.

  PMID: 29991631 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic; Neoplasm, Residual

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Annamaria Iagnocco, Prof

  Università di Torino, Italy

  PRINCIPAL INVESTIGATOR

• Alen Zabotti, MD

  University Hospital "Santa Maria della Misericordia", Udine, Italy

  PRINCIPAL INVESTIGATOR

• Marco Canzoni

  Local Health Unit (ASL) Rome-1, Rome-4, Viterbo, Italy

  PRINCIPAL INVESTIGATOR

• Ignazio Benedetto Olivieri

  Italian Society of Rheumatology

  STUDY CHAIR

Central Study Contacts

Matteo Piga, MD

CONTACT

+3970675; matteopiga@unica.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: February 3, 2017
• Primary Completion: February 28, 2020
• Study Completion: February 29, 2020
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 12 months of study completion.
• Access Criteria: Data access requests will be reviewed by the Steering Committee and by an external independent review panel. Requestors will be required to sign a Data Access Agreement.

Locations

IT (4)