A Study of the Safety and Effectiveness of Ustekinumab in Patients With Psoriatic Arthritis

Conditions

• Arthritis, Psoriatic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  SC injections
• Ustekinumab 45 mg — DRUG
  SC injections
• Ustekinumab 90 mg — DRUG
  SC injections

Study Details

The purpose of this study is to evaluate the effectiveness (improvement of signs and symptoms) and safety of ustekinumab in participants with active psoriatic arthritis.

Key Dates

Start date

Dec 31, 2009

Status verified

Feb 2015

Primary completion

Oct 31, 2011

Completion

May 31, 2013

Study Design

Enrollment

615 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Placebo
  Participants will receive subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants will cross over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, SC injections of 45 mg ustekinumab will be given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a SC placebo injection will be given at Week 24 to maintain the blind.
• Experimental: Ustekinumab 45 mg
  Participants will receive SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, SC injections of 90 mg ustekinumab will be given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.
• Experimental: Ustekinumab 90 mg
  Participants will receive SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, the same dosage schedule will continue. Participants will receive SC injections of placebo at Weeks 20 and 24 to maintain the blind.

Primary Outcome Measure

Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24. [ Time Frame: Week 24 ]

Locations (26)

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