Clinical Trial: A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Ps

Brief Summary: The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Detailed Summary:
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24 [ Time Frame: Week 24 ]

ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change From Baseline in HAQ-DI Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area).
  • Percentage of Participants who Achieve an ACR 50 Response at Week 24 [ Time Frame: Week 24 ]
    ACR 50 Response is defined as >= 50 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
  • Percentage of Participants With a Psoriasis Response of IGA at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline [ Time Frame: Week 24 ]
    Psoriasis response is defined as an Investigator's Global Assessment (IGA) psoriasis score of 0 [cleared] or 1 [minimal] and >=2-grade reduction from baseline. The IGA of Psoriasis documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate) and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  • Percentage of Participants who Achieve an ACR 20 Response at Week 16 [ Time Frame: Week 16 ]
    ACR 20 Response is defined as >= 20 percent improvement from baseline in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement from baseline in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10, 0 = no pain and 10 = worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, 0=very well and 10=very poor), physician's global assessment of disease activity using VAS (0=no arthritis activity and 10 = extremely active arthritis), patient's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
  • Change From Baseline in Modified van der Heijde-Sharp (vdH-S) Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score based on x-rays of both hands and both feet. The total score ranges from 0 to 528 with higher scores indicating more joint damage.
  • Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline [ Time Frame: Week 24 ]
    Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence or absence of pain by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. Leeds Enthesitis Index scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
  • Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants with Dactylitis at Baseline [ Time Frame: Week 24 ]
    The presence and severity of dactylitis will be assessed in both hands and feet using a scoring system from 0 to 3 (0 = no dactylitis, 1 = mild dactylitis, 2 = moderate dactylitis, and 3 = severe dactylitis).
  • Change From Baseline in Enthesitis Score (based on Leeds Enthesitis Index [LEI]) at Week 24 Among the Participants with Enthesitis at Baseline [ Time Frame: Baseline and Week 24 ]
    Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence or absence of pain by applying local pressure to Lateral elbow epicondyle, left and right, Medial

    Original Secondary Outcome: Same as current

    Information By: Janssen Research & Development, LLC

    Dates:
    Date Received: May 16, 2017
    Date Started: July 7, 2017
    Date Completion: December 27, 2021
    Last Updated: May 16, 2017
    Last Verified: May 2017