Clinical trial NCT02319759
Conditions: Psoriatic Arthritis
Keywords: Psoriatic Arthritis Guselkumab Ustekinumab Placebo
Sponsor: Janssen Research & Development, LLC
Start date: 2015-03-27; Completion date: 2017-01-17
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).

Detailed description:
This is a multi-center (more than one clinical site will work on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study to determine the efficacy and safety of guselkumab in participants with PsA. The study will consist of 4 parts: Screening period (6 weeks), a double-blind treatment period (consists of guselkumab and placebo treatment for 24 weeks), an active treatment period (guselkumab for 20 weeks), and follow-up period (12 weeks). The maximal study duration for a participant will not exceed 62 weeks including the Screening period. Eligible participants will be randomly assigned to one of two groups in a 2:1 ratio to either receive Guselkumab 100 milligram (mg) at Weeks 0, 4 then every 8 weeks or Placebo at Weeks 0, 4 then every 8 weeks until Week 24. At week 24, participants remaining in the placebo group will start to receive guselkumab 100 mg at Weeks 24, 28, 36 and 44. Participants in both treatment groups who have less than (\<) 5 percent (%) improvement from baseline in both tender and swollen joint counts at Week 16 will qualify for early escape and will switch to open-label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication in the particular country of study. The efficacy will be assessed primarily by measuring percentage of participants who achieve an American College of Rheumatology (ACR) 20 Response at Week 24. Participants' safety will be monitored throughout the study.

Arms: arm 1: Participants will receive guselkumab 100 milligram (mg) subcutaneous injection (injected under the skin by way of a needle) at Weeks 0, 4, 12, 20, 28, 36, and 44, and placebo for guselkumab at Week 24 to maintain the blind. Participants who enter early escape at Week 16 will switch to open label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study. arm 2: Participants will receive placebo for guselkumab at Weeks 0, 4, 12, and 20, and guselkumab 100 mg subcutaneous injection at Weeks 24, 28, 36, and 44. Participants who enter early escape at Week 16 will switch to open label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.
Interventions: intervention 1: Guselkumab intervention 2: Ustekinumab intervention 3: Placebo
Intervention descriptions: intervention 1: In the guselkumab group, Guselkumab 100 mg subcutaneous injection will be administered at Weeks 0, 4, 12, 20, 28, 36 and 44. In the placebo group, guselkumab 100 mg subcutaneous injection will be administered at Weeks 24, 28, 36 and 44 for participants remaining on placebo at Week 24. intervention 2: In both placebo and guselkumab groups, if the participants qualify for early escape, they will switch to receive ustekinumab 45 mg or 90 mg subcutaneous injection at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study. intervention 3: In placebo group, Placebo subcutaneous injection will be administered at Weeks 0, 4, 12, and 20. In guselkumab group, placebo subcutaneous injection will be administered at Week 24 to maintain the blind.

Protocol documents: