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Multi-Center PAMPA Study (PAMPA)

Primary Purpose

Psoriasis

Status

Recruiting

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Guselkumab

Placebo

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years old or older;
Both male & female;
Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
Willing and able to provide informed consent;
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:

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

Sites / Locations

Brigham and Women's HospitalRecruiting
NYU Langone HealthRecruiting
University of Rochester Medical Center (URMC)Recruiting
Memorial UniversityRecruiting
Women's College Research Institute, University of TorontoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Guselkumab + Topicals (GUS)

Placebo + Topicals (PBO)

Standard-of-Care Therapy (SOC)

Arm Description

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).

Outcomes

Primary Outcome Measures

Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score

Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.

Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at 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: Evidence of current psoriasis (2pts), personal history of psoriasis (2pts), family history (1pt) Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis observed on current physical examination (1pt) A negative test result for the presence of rheumatoid factor by any method except latex (1pt) Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a rheumatologist (1pt) 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

Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1

Severity of PsA at the time of synovio-entheseal development

Severity will be categorized as mild, moderate, or severe.

Change in the ultrasound composite score of synovitis

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.

Change in Madrid Sonographic Enthesis Index (MASEI) Score

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.

Psoriasis Body Surface Area (BSA)

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.

Achieved IGA mod 2011 Score

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

Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale

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.

Change in EuroQol-5D (EQ-5D) Score

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)

Change in EuroQol-5D (EQ-5D) Score

Change in International Dermatology Outcome Measures - Musculoskeletal -8 (IDEOM-MSK-8) Score

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.

Change in Ultrasound Score

Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.

Full Information

NCT ID

NCT05004727

First Posted

August 6, 2021

Last Updated

February 15, 2023

Sponsor

NYU Langone Health

Collaborators

Janssen Scientific Affairs, LLC

1. Study Identification

Unique Protocol Identification Number

NCT05004727

Brief Title

Multi-Center PAMPA Study

Acronym

PAMPA

Official Title

Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 16, 2022 (Actual)

Primary Completion Date

March 1, 2025 (Anticipated)

Study Completion Date

September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

Janssen Scientific Affairs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

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.

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Guselkumab + Topicals (GUS)

Arm Type

Experimental

Arm Title

Placebo + Topicals (PBO)

Arm Type

Placebo Comparator

Arm Title

Standard-of-Care Therapy (SOC)

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Guselkumab

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

• 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).

Primary Outcome Measure Information:

Title

Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score

Description

Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.

Time Frame

Baseline, Week 24

Title

Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2

Description

Time Frame

Year 2

Secondary Outcome Measure Information:

Title

Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1

Description

Time Frame

Year 1

Title

Severity of PsA at the time of synovio-entheseal development

Description

Severity will be categorized as mild, moderate, or severe.

Time Frame

Year 2

Title

Change in the ultrasound composite score of synovitis

Description

Time Frame

Baseline, week 24

Title

Change in Madrid Sonographic Enthesis Index (MASEI) Score

Description

Time Frame

Baseline, week 24

Title

Psoriasis Body Surface Area (BSA)

Description

Time Frame

Week 24

Title

Achieved IGA mod 2011 Score

Description

Time Frame

Week 24

Title

Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale

Description

Time Frame

Week 24

Title

Change in EuroQol-5D (EQ-5D) Score

Description

Time Frame

Baseline, Week 24

Title

Change in EuroQol-5D (EQ-5D) Score

Description

Time Frame

Baseline, Year 2

Title

Change in International Dermatology Outcome Measures - Musculoskeletal -8 (IDEOM-MSK-8) Score

Description

Time Frame

Baseline, Week 24

Title

Change in Ultrasound Score

Description

Score is defined by the ultrasound (General Electric Logiq E9 or E10) equipment, not calculated through a scale.

Time Frame

Baseline, Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years old or older; Both male & female; Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants); Willing and able to provide informed consent; 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: Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam; Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever); RA seropositivity (mid-high RF/ACPA titers); Current active malignancy; History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis; Known hypersensitivity to the study agent.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jose Scher, MD

Phone

6465017400

Jose.Scher@nyulangone.org

First Name & Middle Initial & Last Name or Official Title & Degree

Amina Abdelaziz, EdD

Amina.Abdelaziz@nyulangone.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose Scher, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joseph Merola, MD, MMSc

First Name & Middle Initial & Last Name & Degree

Joseph Merola, MD, MMSc

Facility Name

NYU Langone Health

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose Scher, MD

Jose.Scher@nyulangone.org

First Name & Middle Initial & Last Name & Degree

Amina Abdelaziz, EdD

Amina.Abdelaziz@nyulangone.org

First Name & Middle Initial & Last Name & Degree

Jose Scher, MD

First Name & Middle Initial & Last Name & Degree

Andrea Neimann, MD, MSCE

First Name & Middle Initial & Last Name & Degree

Jonathan Samuels, MD

First Name & Middle Initial & Last Name & Degree

Rebecca Haberman, MD, MSCI

First Name & Middle Initial & Last Name & Degree

Rebecca Blank, MD, PhD

First Name & Middle Initial & Last Name & Degree

Michael Toprover, MD

First Name & Middle Initial & Last Name & Degree

Andrea Troxel, ScD

First Name & Middle Initial & Last Name & Degree

Jiyuan Hu, PhD

Facility Name

University of Rochester Medical Center (URMC)

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher Ritchlin, MD, MPH

Christopher_Ritchlin@urmc.rochester.edu

First Name & Middle Initial & Last Name & Degree

Francisco Tausk, MD

First Name & Middle Initial & Last Name & Degree

Ralf Thiele, MD

First Name & Middle Initial & Last Name & Degree

Christopher Ritchlin, MD, MPH

Facility Name

Memorial University

City

Saint John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1C 5B8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wayne Gulliver, MD

drgulliver@newlabresearch.com

First Name & Middle Initial & Last Name & Degree

Proton Rahman, MD

First Name & Middle Initial & Last Name & Degree

Wayne Gulliver, MD, FRCPC

Facility Name

Women's College Research Institute, University of Toronto

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5S 1B2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lihi Eder, MD PhD

lihi.eder@wchospital.ca

First Name & Middle Initial & Last Name & Degree

Lihi Eder, MD PhD

First Name & Middle Initial & Last Name & Degree

Vincent Piguet, MD PhD

First Name & Middle Initial & Last Name & Degree

Jensen Yeung, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing 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.

Learn more about this trial

Multi-Center PAMPA Study

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