Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

PHASE2CompletedINTERVENTIONAL
Enrollment

149

Participants

Timeline

Start Date

March 27, 2015

Primary Completion Date

May 31, 2016

Study Completion Date

January 17, 2017

Conditions
Psoriatic Arthritis
Interventions
DRUG

Guselkumab

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.

DRUG

Ustekinumab

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.

DRUG

Placebo

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.

Trial Locations (41)

Unknown

Huntsville

Trumbull

Clearwater

Tampa

Sandy Springs

Indianapolis

Boston

Edina

St Louis

Wyomissing

Jackson

Arlington

Barrie

London

Peterborough

Waterloo

Berlin

Cologne

Hamburg

Herne

Kiel

Lübeck

Bialystok

Elblag

Poznan

Warsaw

Bucharest

Bataysk

Moscow

Novosibirsk

Ryazan

Saint Petersburg

Saratov

Ufa

Ulyanovsk

Yaroslavl

Barcelona

Madrid

Sabadell

Santiago de Compostela

Seville

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02319759 - Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA) | Biotech Hunter | Biotech Hunter