A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents

This study is currently recruiting participants.
Verified by Centocor, Inc., March 2011
First Received: February 25, 2010 Last Updated: March 3, 2011

Sponsor:
Centocor, Inc.
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01077362

Purpose
The purpose of this study is to evaluate the efficacy (improvement of signs and symptoms) and safety of ustekinumab in patients with psoriatic arthritis.

Condition Intervention Phase
Arthritis, Psoriatic Drug: ustekinumab
Drug: placebo
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Ustekinumab, a Fully Human Anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNFalpha ?Agent(s)

Further study details as provided by Centocor, Inc.:
Primary Outcome Measures:

  • The proportion of patients with American College of Rheumatology (ACR) 20 response at Week 24. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • The change from baseline in total radiographic scores of the hands and feet at Week 24. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • The change from baseline in the Health Assessment Questionnaire score at Week 24. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • The proportion of patients with American College of Rheumatology (ACR) 50 and ACR 70 responses at Week 24. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • The proportion of patients (with baseline = 3% body surface area (BSA) psoriatic involvement) who achieve a Psoriasis Area and Severity Index (PASI) 75 response at Week 24. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions

001: Experimental
placebo Subcutaneously (SC) at Wks 0 4 16 20 24 28 40,ustekinumab 45 mg subcutaneously (SC) at Wks 0 4 and every 12 wks to Wk 40,ustekinumab If Early Escape 90 mg subcutaneously (SC) at Wk 16 & every 12 wks to Wk 40
Interventions:

  • Drug: ustekinumab
  • Drug: placebo
  • Drug: ustekinumab

Drug: ustekinumab
45 mg subcutaneously (SC) at Wks 0, 4 and every 12 wks to Wk 40|
Drug: placebo
Subcutaneously (SC) at Wks 0, 4, 16, 20, 24, 28, 40
Drug: ustekinumab
If Early Escape, 90 mg subcutaneously (SC) at Wk 16 & every 12 wks to Wk 40

 

 

 

002: Experimental
placebo Subcutaneously (SC) at Wks 0 4 16 20 24 28 40,ustekinumab 90 mg subcutaneously (SC) at Wks 0 4 and every 12 wks to Wk 40 Interventions:

  • Drug: ustekinumab
  • Drug: placebo

Drug: ustekinumab
90 mg subcutaneously (SC) at Wks 0, 4 and every 12 wks to Wk 40
Drug: placebo
Subcutaneously (SC) at Wks 0, 4, 16, 20, 24, 28, 40

 

 

003: Experimental
placebo Subcutaneously (SC) at Wks 0 4 16 20 24 28 40,ustekinumab 45 mg subcutaneously (SC) at Wk 24 28 & 40,ustekinumab If Early Escape 45 mg subcutaneously (SC) at Wk 16 20 28 & 40
Interventions:

  • Drug: placebo
  • Drug: ustekinumab
  • Drug: ustekinumab

Drug: placebo
Subcutaneously (SC) at Wks 0, 4, 16, 20, 24, 28, 40
Drug: ustekinumab
If Early Escape, 45 mg subcutaneously (SC) at Wk 16, 20, 28 & 40
Drug: ustekinumab
45 mg subcutaneously (SC) at Wk 24, 28 & 40

 

 

Detailed Description:
This study is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), parallel-group, multicenter study to evaluate the effectiveness and safety of ustekinumab compared to placebo in the treatment of patients with active psoriatic arthritis who have or are currently receiving treatment with a disease-modifying antirheumatic drug (DMARD) and/or a nonsteroidal anti-inflammatory drug (NSAID), including those who have previously received anti-tumor necrosis factor (anti-TNF) agents [(examples are infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira)]. The primary effectiveness endpoint will be measured by the reduction in signs and symptoms of arthritis, as defined by 20% improvement from baseline in American College of Rheumatology (ACR) measurements of arthritis at Week 24. The study will additionally look at higher levels of joint improvement (ie, 50% or 70% improvement from baseline) and improvement in activity and quality of life, as well as the impact of ustekinumab on psoriatic skin lesions. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure) and the occurrence and severity of adverse events (side effects). Patients will be assigned to one of three treatment groups. Patients will receive either 45 mg ustekinumab, 90 mg ustekinumab, or placebo at Weeks 0, 4 and every 12 weeks until Week 40. Patients who do not have >=5% improvement in their disease (tender and swollen joints) at Week 16 may be eligible to receive an increase or change to their ustekinumab dosage. Ustekinumab 45 mg, 90 mg, or placebo subcutaneous injections at Weeks 0 and 4 followed by every-12-week dosing with the last dose at Week 40. Early escape possibility at Week 16. Patients randomized to placebo will crossover to receive ustekinumab at Weeks 24 and 28 followed by every-12-week dosing with the last dose at Week 40. Expected duration of exposure to study agent including follow up for safety is 60 weeks.

Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:

  • Have had a documented diagnosis of psoriatic arthritis (PsA) at least 6 months
  • Have a diagnosis of active PsA at the time of entry into the study with at least 5 tender and 5 swollen joints at baseline
  • May have previously received at least 8 weeks of etanercept, adalimumab, golimumab or certolizumab pegol or at least 14 weeks of infliximab or proven inability to tolerate anti-TNF therapy for 8-14 weeks
  • If the patient is using methotrexate, they should have started treatment at a dose not to exceed 25 mg/week at least 3 months prior to the beginning of the study and should have no serious toxic side effects attributable to methotrexate

Exclusion Criteria:

  • Have other inflammatory diseases, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
  • Have used any therapeutic agent targeted at reducing IL-12 or IL-23, including but not limited to ustekinumab and ABT-874
  • Have used infliximab, golimumab or certolizumab pegol within 12 weeks of first study drug injection, or etanercept or adalimumab within 8 weeks of first study drug injection
  • Have a medical history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening
  • Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years of the beginning of the study
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