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Ultrasound Enthesitis Response in Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT03955861
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Collaborators:
British Medical Association
Psoriasis and Psoriatic Arthritis Alliance
Queen's University, Belfast
Information provided by (Responsible Party):
Belfast Health and Social Care Trust

Study Description
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Brief Summary:

The aim of this observational study will be to recruit 100 Psoriatic Arthritis (PsA) patients beginning on their biologic therapy and asses, both clinically and with the use of ultrasound (US), how enthesitis responds to biologic treatment.

The decision to start treatment with a biologic therapy will be made by the patients' usual clinical rheumatology team, as part of their standard clinical care. This is independent of the study. Patients in whom treatment with these drugs for their PsA has been recommended will then be invited to participate in this study.They will then be commenced on biologic therapy at doses in line with the Summary of Product characteristics (SPC) for the product and followed up in the hospital outpatient clinic.

Patients will have a full history taken and clinical exam performed prior to commencing on their prescribed biologic. The patient's history, Health Assessment Questionnaire scores and biobanking samples will be taken by the co-investigator. They will also calculate the patients tender and swollen joint score, dactylitis score, skin score, nail score and clinical enthesitis score.They will then have their tender entheseal points scanned as well as those as per the MASEI (Madrid Sonographic Enthesitis Index ) protocol by a single rheumatologist. The rheumatologist will be trained in ultrasound and will perform the scans blinded to this information both at initial consultation and at subsequent reviews.

The patient will then commence their biologic treatment as planned at a separate review as per usual practise with their clinical team.

Follow-up and final assessment at 4 months (±2 weeks) after starting biologic will include the clinical and ultrasound assessments as per the initial review and outlined in the schedule of assessments. They will also have a final blood sample taken at this point.


Condition or disease Intervention/treatment
Psoriatic Arthritis Psoriasis Enthesitis Biological: adalimumab Biological: Certolizumab Biological: Etanercept Biological: Golimumab Biological: Secukinumab

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Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study Evaluating the Utility of Ultrasound Confirmed Enthesitis as a Prognostic Marker for Response to Biologic Therapy in Psoriatic Arthritis
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Biological: adalimumab
    Subcutaneous injection
    Other Name: Humira
  • Biological: Certolizumab
    Subcutaneous injection
    Other Name: Cimzia
  • Biological: Etanercept
    Subcutaneous injection
    Other Name: Enbrel
  • Biological: Golimumab
    Subcutaneous injection
    Other Name: Simponi
  • Biological: Secukinumab
    Subcutaneous injection
    Other Name: Cosentyx

Outcome Measures
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Primary Outcome Measures :
  1. The change in Madrid enthesitis ultrasound index (MASEI) score [ Time Frame: 4 months ]
    Ultrasound enthesitis response score. This is a validated tool for assessing enthesitis in spondyloarthropathy. It assess both chronic a active features of enthesitis at the knee, plantar fascia, achilles tendon and triceps tendon. A total score of 136 can be achieved.


Secondary Outcome Measures :
  1. The change in Minimal Disease Activity (MDA) response from baseline assessment [ Time Frame: 4 months ]

    Composite clinical score for Psoriatic Arthritis. To be classified as MDA you need to achieve a score of at least 5/7 in the following parameters.

    • Swollen Joint count of ≤ 1 of 66
    • Tender joint score of ≤ 1 out of 68
    • Either a PASI (Psoriasis Area Severity Index) skin score ≤ 15 or a Body Surface Score (BSA) of ≤ 3%
    • Patient Pain Visual Analogue Score (VAS) of ≤ 15
    • Patient Global Disease Activity VAS of ≤ 20
    • HAQ ≤ 0.5
    • Tender Entheseal score of ≤1out of 6 as per the Leeds Enthesitis score

  2. The change in Leeds Enthesitis Index (LEI) score from baseline assessment [ Time Frame: 4 months ]

    Enthesitis clinical score that gives a score out of 6 based on clinical exam of entheseal sites at

    • Both Lateral Epicondyle of the Humerus
    • Both Medial Condyle of the Femur
    • Both Achilles insertion

  3. The change in Dactylitis score from baseline assessment [ Time Frame: 4 months ]
    Dactylitis is the uniform swelling of a whole digit such that the joints cannot be identified. Tenderness when examining dactylitis should be recorded. One dactylitic digit = one swollen joint and score is out of 20 for all five digits.

  4. The change in 66/68 tender and swollen joint counts from baseline assessment [ Time Frame: 4 months ]
    Validated tool to assess 68 sites for tender joints and 66 sites for swollen joints above and below the waist in Psoriatic Arthritis

  5. The change in Psoriatic Arthritis Response Criteria (PsARC) response from baseline assessment [ Time Frame: 4 months ]

    Composite disease activity score in Psoriatic Arthritis

    The PsARC is defined as improvement in at least two of the following 4 criteria (one of which must be tender joint or swollen joint score) with no worsening of any criteria:

    20% or more improvement in physician global assessment of disease activity 20% or more improvement in patient global assessment of disease activity 30% or more improvement in tender joint count 30% or more improvement in swollen joint count


  6. Assess change in Ultrasound (US) findings at nail bed [ Time Frame: 4 months ]
    Nail bed semi quantitative score changes looking at nail bed matrix thickness, nail plate morphology, colour doppler signal and nail bed thickness

  7. Relationship of baseline MASEI score to the clinical outcomes at baseline [ Time Frame: 4 months ]
    A regression analysis will be a carried out on the improvement in participant ultrasound enthesitis scores at 4 months with relation to clinical outcomes


Biospecimen Retention:   Samples With DNA
Bloods samples with whole blood/serum/plasma storage for future biomarker analysis

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Psoriatic Arthritis patients with active disease who are naive to biologic therapy
Criteria

Inclusion criteria for PsA patients

Patients with PsA will be included if they meet ALL of the following criteria:

  1. Aged ≥ 18 years
  2. Fulfil the Classification criteria for PSA (CASPAR)
  3. Have not previously had biologic disease modifying treatment for their PsA
  4. Are due to commence on subcutaneous TNF inhibitor or secukinumab as part of their standard clinical care, in line with SPC for the product prescribed
  5. Are able and willing to give informed consent and comply with the requirements of the study protocol NOTE: DMARD therapy will be permitted and used as per standard clinical practice

Exclusion criteria:

Patients will not be eligible if they meet ANY of the following criteria:

  1. History of or current autoimmune rheumatic disease other than PsA
  2. Previously received a biologic therapy for PsA
  3. Receiving infliximab (IV TNF inhibitor)
  4. Haemoglobin ≤9 g/dl
  5. Known HUMAN immunodeficiency Virus (HIV), hepatitis C or B infection
  6. Current oral steroids
  7. Intramuscular steroids within 6 weeks of baseline (IA steroid injection will be allowed) assessment
  8. Pregnancy or breast feeding
  9. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness. -
Contacts and Locations
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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): NCT03955861


Contacts
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Contact: Madeline Rooney, MB Bch BAO +447895563206 M.Rooney@qub.ac.uk
Contact: Alison Murphy +442890636366 alison.murphy@belfasttrust.hscni.net

Locations
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United Kingdom
Musgrave Park Hospital Recruiting
Belfast, Antrim, United Kingdom, BT9 7JB
Contact: Ashley Elliott, MB Bch BAO    +447895563206    aelliott09@doctors.org.uk   
Contact: Madeleine Rooney, MD    +447711719293    M.Rooney@qub.ac.uk   
Sponsors and Collaborators
Belfast Health and Social Care Trust
British Medical Association
Psoriasis and Psoriatic Arthritis Alliance
Queen's University, Belfast
Investigators
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Study Director: Madeleine Rooney, MD Queens University, Belfast
More Information
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Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT03955861     History of Changes
Other Study ID Numbers: 18046MR-SW
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Enthesopathy
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Tendinopathy
Muscular Diseases
 Tendon Injuries
Wounds and Injuries
Adalimumab
Etanercept
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors