Clinical Trial: A Study of Golimumab in Participants With Active Psoriatic Arthritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects With Active Psoriat

Brief Summary: The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).

Detailed Summary: This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of golimumab compared with placebo in participants with active psoriatic arthritis. The study will include 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase (Week 0 to Week 24), Active treatment phase (Week 24 to Week 52), and Safety follow-up phase (8 weeks from last study drug administration). Total duration of the study will be 60 weeks per participant. Eligible Participants will be randomly assigned to either Treatment Group 1: Placebo or Treatment Group 2: Golimumab. Participants randomized to Placebo Group, will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all participants receiving placebo will begin receiving intravenous infusions of golimumab (2 mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab Group, will receive intravenous infusions of golimumab 2 mg/kg at Week 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants randomized to golimumab Group will receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by measuring percentage of participants who achieve a 20 percent improvement from baseline in the assessment used in active psoriatic arthritis at Week 14. Participants' safety will be monitored throughout the study.
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 14 [ Time Frame: Week 14 ]

The ACR 20 response is defined as greater or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) score at Week 14 [ Time Frame: Baseline and week 14 ]
    The HAQ-DI 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), each scored from 0 (no difficulty) to 3 (inability to perform a task).
  • Percentage of Participants who Achieve an ACR 50 Response at Week 14 [ Time Frame: Week 14 ]
    The ACR 50 response is defined as: greater or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
  • Percentage of Participants achieving Psoriatic Area and Severity Index (PASI) 75 response at Week 14 [ Time Frame: Week 14 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy that is scored from 0 to 72. PASI 75 response is defined as >=75% improvement in PASI score from baseline.
  • Change from baseline in total 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. For the change from baseline, positive values show an increase in damage.


Original Secondary Outcome:

  • Change from baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) score at Week 14 [ Time Frame: Baseline and week 14 ]
    The HAQ-DI 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), each scored from 0 (no difficulty) to 3 (inability to perform a task).
  • Percentage of Participants who Achieve an ACR 50 Response at Week 14 [ Time Frame: Week 14 ]
    The ACR 50 response is defined as: greater or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
  • Percentage of Participants achieving Psoriatic Area and Severity Index (PASI) 75 response at Week 14 [ Time Frame: Week 14 ]
    The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy that is scored from 0 to 72. PASI 75 response is defined as >=75% improvement in PASI score from baseline.
  • Change from baseline in total 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. For the change from baseline, positive values show an increase in damage.
  • Change from baseline in 36-item short form health survey (SF-36) physical Component Summary (PCS) at Week 14 [ Time Frame: Baseline and week 14 ]
    36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores. All scores are based on a scale from 0 to 100, with higher scores indicating more favorable health state.


Information By: Janssen Research & Development, LLC

Dates:
Date Received: July 2, 2014
Date Started: September 8, 2014
Date Completion:
Last Updated: April 20, 2017
Last Verified: April 2017