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Ultrasound in Psoriatic Arthritis Treatment (UPSTREAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330769
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Italian Society for Rheumatology
University of Turin, Italy
University Hospital, Udine, Italy
Azienda Sanitaria Locale Roma E
Information provided by (Responsible Party):
Matteo Piga, University of Cagliari

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.


Condition or disease Intervention/treatment
Arthritis, Psoriatic Ultrasonography Minimal Disease, Residual Drug: New course of treatment

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound in PSoriatic Arthritis TREAtMent - UPSTREAM
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : February 29, 2020


Group/Cohort Intervention/treatment
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
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.
Other Names:
  • NSAIDs
  • steroid intra-articular injections
  • Conventional DMARDs
  • biologic DMARDs




Primary Outcome Measures :
  1. Minimal disease activity [ Time Frame: 6 months ]

    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).


Secondary Outcome Measures :
  1. Minimal disease activity [ Time Frame: 12 months ]

    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. 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).


  2. Disease Activity for Psoriatic Arthritis (DAPSA) [ Time Frame: 6 and 12 months ]

    The DAPSA calculation is based on the evaluation of 5 variables:

    1. 68 tender joints count (TJC)
    2. 66 swollen joint count (SJC)
    3. Patient's pain (VAS)
    4. Patient's global disease activity assessment (VAS)
    5. C-reactive protein

    As a result the DAPSA index gives a value with:

    >28 indicating high disease activity 14-28 indicating moderate disease activity 4-13 indicating low disease activity

    ≤4 indicating complete remission

    Using DAPSA the clinical response can be defined:

    Minor : 50% DAPSA change from baseline Moderate: 75% DAPSA change from baseline Major : 85% DAPSA change from baseline


  3. American College of Rheumatology (ACR) response score [ Time Frame: 6 and 12 months ]

    The ACR 20 response criteria require ≥ 20% [ACR 50 ≥ 50% or ACR 70 ≥ 70%] improvement in both the TJC and SJC, as well as a 20% improvement in 3 of the following 5 items:

    1. patient global assessments of disease activity (VAS),
    2. patient reported pain score (VAS),
    3. physician global assessment (VAS),
    4. Health Assessment Questionnaire (HAQ),
    5. either Erythrocyte Sedimentation Rate (ESR) or C-Reactive Protein (CRP).

  4. X-ray structural progression (mSVH score) [ Time Frame: 12 and 24 months ]
    Using the modified Sharp-Vander Heijde score. at 12 and 24 months

  5. Ultraosund structural progression [ Time Frame: 12 and 24 months ]
    US-damage score

  6. Functional worsening [ Time Frame: 12 and 24 months ]
    Functional worsening with a delta HAQ>0.23.

  7. Health Related Quality of life [ Time Frame: 12 and 24 months ]
    Impairment of HRQoL using the PSAID-12 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Clinically diagnosed PsA with clinically active joint disease starting a new course of therapy for active joint disease.
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • Minimal disease activity a the time of enrolment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330769


Contacts
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Contact: Matteo Piga, MD +3970675 ext 4069 matteopiga@unica.it

Locations
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Italy
Azienda Ospedaliera Universitaria Recruiting
Cagliari, Italy, 09042
Contact: Matteo Piga    +3970609 ext 3348      
Local Health Unit (ASL) Rome-1, Rome-4 Recruiting
Roma, Italy
Contact: Marco Canzoni         
University of Turin Recruiting
Torino, Italy
Contact: Annamaria Iagnocco         
University Hospital "Santa Maria della Misericordia" Recruiting
Udine, Italy
Contact: Alen Zabotti         
Sponsors and Collaborators
University of Cagliari
Italian Society for Rheumatology
University of Turin, Italy
University Hospital, Udine, Italy
Azienda Sanitaria Locale Roma E
Investigators
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Principal Investigator: 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
Study Chair: Ignazio Benedetto Olivieri Italian Society of Rheumatology
  Study Documents (Full-Text)

Documents provided by Matteo Piga, University of Cagliari:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matteo Piga, Researcher, University of Cagliari
ClinicalTrials.gov Identifier: NCT03330769    
Other Study ID Numbers: F8MRG
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available to all investigators participating in the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matteo Piga, University of Cagliari:
Psoriatic Arthritis
Ultrasonography
Minimal disease activity
Additional relevant MeSH terms:
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Neoplasm, Residual
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Antirheumatic Agents