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

NCT ID: NCT02319759

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-27
• Study Completion Date: 2017-01-17

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.

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Guselkumab

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.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

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.

Ustekinumab

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

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.

Placebo

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.

Group Type: EXPERIMENTAL

Guselkumab

Intervention Type: DRUG

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.

Ustekinumab

Intervention Type: DRUG

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.

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening
• Had active PsA as defined by:

1. At least 3 swollen joints and at least 3 tender joints at Screening and at baseline

2. C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory

• Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
• Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (>=) 3% at Screening and baseline
• Has active PsA despite current or previous non-biologic disease-modifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
• If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable

Exclusion Criteria

• Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
• Has previously received guselkumab or ustekinumab
• Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
• Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
• Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Huntsville, Alabama, United States

Trumbull, Connecticut, United States

Clearwater, Florida, United States

Tampa, Florida, United States

Sandy Springs, Georgia, United States

Indianapolis, Indiana, United States

Boston, Massachusetts, United States

Edina, Minnesota, United States

St Louis, Missouri, United States

Wyomissing, Pennsylvania, United States

Jackson, Tennessee, United States

Arlington, Virginia, United States

Barrie, Ontario, Canada

London, Ontario, Canada

Peterborough, Ontario, Canada

Waterloo, Ontario, Canada

Berlin, , Germany

Cologne, , Germany

Hamburg, , Germany

Herne, , Germany

Kiel, , Germany

Lübeck, , Germany

Bialystok, , Poland

Elblag, , Poland

Poznan, , Poland

Warsaw, , Poland

Bucharest, , Romania

Bataysk, , Russia

Moscow, , Russia

Novosibirsk, , Russia

Ryazan, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Ufa, , Russia

Ulyanovsk, , Russia

Yaroslavl, , Russia

Barcelona, , Spain

Madrid, , Spain

Sabadell, , Spain

Santiago de Compostela, , Spain

Seville, , Spain

Countries

United States; Canada; Germany; Poland; Romania; Russia; Spain

References

Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.

Reference Type: DERIVED

PMID: 37906417 (View on PubMed)

Rahman P, Boehncke WH, Mease PJ, Gottlieb AB, McInnes IB, Shawi M, Wang Y, Sheng S, Kollmeier AP, Theander E, Yu J, Leibowitz E, Marrache AM, Coates LC. Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. J Rheumatol. 2023 Jun;50(6):769-780. doi: 10.3899/jrheum.220928. Epub 2023 Jan 15.

Reference Type: DERIVED

PMID: 36642439 (View on PubMed)

Mease PJ, Gladman DD, Deodhar A, McGonagle DG, Nash P, Boehncke WH, Gottlieb A, Xu XL, Xu S, Hsia EC, Karyekar CS, Helliwell PS. Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study. RMD Open. 2020 Jul;6(2):e001217. doi: 10.1136/rmdopen-2020-001217.

Reference Type: DERIVED

PMID: 32665433 (View on PubMed)

Helliwell PS, Deodhar A, Gottlieb AB, Boehncke WH, Xu XL, Xu S, Wang Y, Hsia EC, Gladman DD, Ritchlin CT. Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1579-1588. doi: 10.1002/acr.24046.

Reference Type: DERIVED

PMID: 31421033 (View on PubMed)

Deodhar A, Gottlieb AB, Boehncke WH, Dong B, Wang Y, Zhuang Y, Barchuk W, Xu XL, Hsia EC; CNTO1959PSA2001 Study Group. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2018 Jun 2;391(10136):2213-2224. doi: 10.1016/S0140-6736(18)30952-8. Epub 2018 Jun 1.

Reference Type: DERIVED

PMID: 29893222 (View on PubMed)

Other Identifiers

2014-003697-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNTO1959PSA2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR105964

Identifier Type: -

Identifier Source: org_study_id