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Multi-Center PAMPA Study (PAMPA)

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ClinicalTrials.gov Identifier: NCT05004727
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : January 5, 2024
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care.

The primary objective of our proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will:

  1. Diminish MSKPDUS findings at 24 weeks, and
  2. Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: Guselkumab Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Participants, investigator staff, persons performing the assessments, and the CTT will remain blind to the identity of the treatment from the time of randomization until database lock.
Primary Purpose: Treatment
Official Title: Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort
Actual Study Start Date : February 16, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Guselkumab

Arm Intervention/treatment
Experimental: Guselkumab + Topicals (GUS) Drug: Guselkumab
Guselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).

Placebo Comparator: Placebo + Topicals (PBO) Drug: Guselkumab
Guselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).

Drug: Placebo
• Placebo to Guselkumab 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (Month 0 to Week 20 for Arm 2).

No Intervention: Standard-of-Care Therapy (SOC)
In this third, non-randomized arm, patients would continue treatment with topical therapy or UVB, as part of our ongoing natural history of disease registries. This arm will include participants fulfilling RM-PsASon criteria but also those that do not (to serve as "negative" controls).



Primary Outcome Measures :
  1. Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score [ Time Frame: Baseline, Week 24 ]
    Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.

  2. Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2 [ Time Frame: Year 2 ]

    To meet CASPAR criteria for diagnosis of PsA, a participant must have inflammatory articular disease (joint, spine, entheseal or dactyitic) and at least 3 points from the following:

    1. Evidence of current psoriasis (2pts), personal history of psoriasis (2pts), family history (1pt)
    2. Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis observed on current physical examination (1pt)
    3. A negative test result for the presence of rheumatoid factor by any method except latex (1pt)
    4. Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a rheumatologist (1pt)
    5. Radiographic evidence of juxta-articular new bone formation appearing as ill-defined ossification near joint margins (but excluding osteophyte formation) on plain radiographs of the hand or foot (1pt) The eCRF will autopopulate the total number of points. If the total score ≥ 3, the participant meets criteria for PsA diagnosis.


Secondary Outcome Measures :
  1. Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1 [ Time Frame: Year 1 ]

    To meet CASPAR criteria for diagnosis of PsA, a participant must have inflammatory articular disease (joint, spine, entheseal or dactyitic) and at least 3 points from the following:

    1. Evidence of current psoriasis (2pts), personal history of psoriasis (2pts), family history (1pt)
    2. Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis observed on current physical examination (1pt)
    3. A negative test result for the presence of rheumatoid factor by any method except latex (1pt)
    4. Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a rheumatologist (1pt)
    5. Radiographic evidence of juxta-articular new bone formation appearing as ill-defined ossification near joint margins (but excluding osteophyte formation) on plain radiographs of the hand or foot (1pt) The eCRF will autopopulate the total number of points. If the total score ≥ 3, the participant meets criteria for PsA diagnosis.

  2. Severity of PsA at the time of synovio-entheseal development [ Time Frame: Year 2 ]
    Severity will be categorized as mild, moderate, or severe.

  3. Change in the ultrasound composite score of synovitis [ Time Frame: Baseline, week 24 ]
    Graded from 0-3 as absent, mild, moderate or severe according to images of a reference atlas (Hammer HB 2011). PD signal: 0=no PD-signal, 1=up to three single or two confluent signals, 2=less than half of the visible intracapsular area and 3=half or more of the visible intracapsular area covered by PD-signals.

  4. Change in Madrid Sonographic Enthesis Index (MASEI) Score [ Time Frame: Baseline, week 24 ]
    MASEI: Structure is considered pathological (score=1) if there is a loss of fibrillar pattern, hypoechoic aspect, or fusiform thickening of the entheses. Erosions are defined as a cortical breakage with a step-down contour defect at the attachment of entheses at bone and graded with 0=absent or 3=present. Fascia and tendon thickness are measured at the point of maximal thickness on the bony insertion and graded with 0=normal or 1=thickened according to the reference values of the MASEI index. Enthesophytes are defined as calcifications at the entheses insertions into bone and graded with 0=absent, 1=small calcification, 2=clear presence of enthesophyte/calcification, 3= large calcifications or ossifications. PD-signals within entheses are scored with 0=absent or 3=present. Bursitis is investigated at the level of distal patellar tendon (infrapatellar bursitis) and the level of Achilles tendon insertion (retrocalcaneal bursitis) and graded with 0=absent and 1=present.

  5. Psoriasis Body Surface Area (BSA) [ Time Frame: Week 24 ]
    The total BSA affected by plaque-type psoriasis will be estimated from the percentages of areas affected, including head, trunk, upper limbs and lower limbs. The following calculations will be done: each reported percentage will be multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages will be added up to estimate the total BSA affected by psoriasis.

  6. Achieved IGA mod 2011 Score [ Time Frame: Week 24 ]
    Score 0 - Clear - No signs of psoriasis. Post-inflammatory hyperpigmentation may be present Score 1 - Almost clear - Normal to pink coloration of lesions; no thickening; no to minimal focal scaling Score 2 - Mild disease - Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling Score 3 - Moderate disease - Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling Score 4 - Severe disease - Bright to deep dark red coloration; severe thickening with hard edges; severe / coarse scaling covering almost all or all lesions

  7. Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale [ Time Frame: Week 24 ]
    FACIT consists of 13 statements regarding fatigue (e.g., "I feel fatigued", "I feel weak all over", "I feel tired", etc.). Items are scored as follows: 4=not at all, 3=a little bit, 2=somewhat, 1=quite a bit; 0=very much, EXCEPT items #7 and 8 which are reversed scored. Total score range is 0-52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life.

  8. Change in EuroQol-5D (EQ-5D) Score [ Time Frame: Baseline, Week 24 ]
    The scale measures how good or bad one's health is on the day of the questionnaire. Total score is 0-100; the higher the score, the better the health (0 = worst health one can imagine, 100 = best health one can imagine)

  9. Change in EuroQol-5D (EQ-5D) Score [ Time Frame: Baseline, Year 2 ]
    The scale measures how good or bad one's health is on the day of the questionnaire. Total score is 0-100; the higher the score, the better the health (0 = worst health one can imagine, 100 = best health one can imagine)

  10. Change in International Dermatology Outcome Measures - Musculoskeletal -8 (IDEOM-MSK-8) Score [ Time Frame: Baseline, Week 24 ]
    IDEOM-MSK-8 is a short questionnaire that allows people with MSK conditions to report their symptoms and quality of life in a standardized way. The total range of score is 0-56; the higher the score, the better the MSK health status. In order to calculate the total score, the numbers next to the boxes that the participant has ticked on the questionnaire form is added up.

  11. Change in Ultrasound Score [ Time Frame: Baseline, Week 24 ]
    Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years old or older;
  2. Both male & female;
  3. Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
  4. Willing and able to provide informed consent;
  5. Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition of HR if they fulfill the following criteria: a) PsO duration >2 years and Psoriasis Body Surface Area (BSA) >3% and positive imaging findings in MSKPDUS defined as a RM-PsASon score of >3.36

Exclusion Criteria:

  1. Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
  2. Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
  3. RA seropositivity (mid-high RF/ACPA titers);
  4. Current active malignancy;
  5. History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
  6. Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
  7. Known hypersensitivity to the study agent.

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): NCT05004727


Contacts
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Contact: Jose Scher, MD 6465017400 Jose.Scher@nyulangone.org
Contact: Fizaa Ahmed Fizaa.Ahmed@nyulangone.org

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Joseph Merola, MD, MMSc         
Principal Investigator: Joseph Merola, MD, MMSc         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Jose Scher, MD       Jose.Scher@nyulangone.org   
Contact: Amina Abdelaziz, EdD       Amina.Abdelaziz@nyulangone.org   
Principal Investigator: Jose Scher, MD         
Sub-Investigator: Andrea Neimann, MD, MSCE         
Sub-Investigator: Jonathan Samuels, MD         
Sub-Investigator: Rebecca Haberman, MD, MSCI         
Sub-Investigator: Rebecca Blank, MD, PhD         
Sub-Investigator: Michael Toprover, MD         
Sub-Investigator: Andrea Troxel, ScD         
Sub-Investigator: Jiyuan Hu, PhD         
University of Rochester Medical Center (URMC) Recruiting
Rochester, New York, United States, 14623
Contact: Christopher Ritchlin, MD, MPH         
Contact       Christopher_Ritchlin@urmc.rochester.edu   
Sub-Investigator: Francisco Tausk, MD         
Sub-Investigator: Ralf Thiele, MD         
Principal Investigator: Christopher Ritchlin, MD, MPH         
Canada, Newfoundland and Labrador
Memorial University Recruiting
Saint John's, Newfoundland and Labrador, Canada, A1C 5B8
Contact: Wayne Gulliver, MD       drgulliver@newlabresearch.com   
Sub-Investigator: Proton Rahman, MD         
Principal Investigator: Wayne Gulliver, MD, FRCPC         
Canada, Ontario
Women's College Research Institute, University of Toronto Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Lihi Eder, MD PhD       lihi.eder@wchospital.ca   
Principal Investigator: Lihi Eder, MD PhD         
Sub-Investigator: Vincent Piguet, MD PhD         
Sub-Investigator: Jensen Yeung, MD         
Sponsors and Collaborators
NYU Langone Health
Janssen Scientific Affairs, LLC
Investigators
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Principal Investigator: Jose Scher, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT05004727    
Other Study ID Numbers: 20-01158
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to jose.scher@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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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.: Yes
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases