A Study of Golimumab in Participants With Active Psoriatic Arthritis

NCT ID: NCT02181673

Last Updated: 2017-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-08
• Study Completion Date: 2017-03-22

Brief Summary

The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).

Detailed Description

This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study of golimumab compared with placebo in participants with active psoriatic arthritis. The study will include 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase (Week 0 to Week 24), Active treatment phase (Week 24 to Week 52), and Safety follow-up phase (8 weeks from last study drug administration). Total duration of the study will be 60 weeks per participant. Eligible Participants will be randomly assigned to either Treatment Group 1: Placebo or Treatment Group 2: Golimumab. Participants randomized to Placebo Group, will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all participants receiving placebo will begin receiving intravenous infusions of golimumab (2 mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab Group, will receive intravenous infusions of golimumab 2 mg/kg at Week 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants randomized to golimumab Group will receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by measuring percentage of participants who achieve a 20 percent improvement from baseline in the assessment used in active psoriatic arthritis at Week 14. Participants' safety will be monitored throughout the study.

Conditions

Arthritis, Psoriatic

Keywords

Psoriatic arthritis; Golimumab; Simponi

Study Design

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

Study Groups

Treatment Group 1: Placebo

Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.

Golimumab

Intervention Type: DRUG

Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.

Treatment Group 2: Golimumab

Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants will receive a placebo infusion to maintain the blind.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.

Golimumab

Intervention Type: DRUG

Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.

Interventions

Placebo

Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.

Intervention Type: DRUG

Golimumab

Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have had psoriatic arthritis (PsA) for at least 6 months prior to the first administration of study agent
• Have a diagnosis of active PSA as defined by 5 or more swollen joints and 5 or more tender joints at Screening and at Baseline and C-reactive protein >=0.6 milligram per deciliter (mg/dL) at Screening
• Have active plaque psoriasis or a documented history of plaque psoriasis
• Have active PsA despite current or previous disease-modifying antirheumatic drugs (DMARD) and/or nonsteroidal anti-inflammatory drug (NSAID) therapy. DMARD therapy is defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance. NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID intolerance

Exclusion Criteria

• Have other inflammatory diseases that might confound the evaluations of benefit of Golimumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease
• Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the study or within 4 months after receiving the last administration of study agent
• Have used any biologic agents that are targeted for reducing tumor necrosis factors (TNF) alpha, including but not limited to Infliximab, Etanercept, Adalimumab, Golimumab, and Certolizumab Pegol
• Have ever used cytotoxic drugs, including Chlorambucil, Cyclophosphamide, Nitrogen mustard, or other Alkylating agents

• 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

Glendale, Arizona, United States

Mesa, Arizona, United States

Huntington Beach, California, United States

Lakewood, California, United States

Granger, Indiana, United States

Indianapolis, Indiana, United States

Monroe, Louisiana, United States

Tupelo, Mississippi, United States

St Louis, Missouri, United States

Orchard Park, New York, United States

Salisbury, North Carolina, United States

Duncansville, Pennsylvania, United States

Austin, Texas, United States

Daw Park, , Australia

Maroochydore, , Australia

Grodno, , Belarus

Homyel, , Belarus

Minsk, , Belarus

Vitebsk, , Belarus

St. John's, Newfoundland and Labrador, Canada

Waterloo, Ontario, Canada

Burlington, , Canada

Bad Doberan, , Germany

Berlin, , Germany

Cologne, , Germany

Erfurt, , Germany

Hamburg, , Germany

Ratingen, , Germany

Zerbst, , Germany

Balatonfüred, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Hévíz, , Hungary

Kistarcsa, , Hungary

Nyíregyháza, , Hungary

Szombathely, , Hungary

Alytus, , Lithuania

Kaunas, , Lithuania

Klaipėda, , Lithuania

Šiauliai, , Lithuania

Vilnius, , Lithuania

Bydgoszcz, , Poland

Bytom, , Poland

Częstochowa, , Poland

Krakow, , Poland

Lublin, , Poland

Nadarzyn, , Poland

Nowa Sól, , Poland

Poznan, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Bucharest, , Romania

Constanța, , Romania

Iași, , Romania

Ploieşti, , Romania

Kemerovo, , Russia

Korolyov, , Russia

Krasnoyarsk, , Russia

Kursk, , Russia

Moscow, , Russia

Novosibirsk, , Russia

Orenburg, , Russia

Petrozavodsk, , Russia

Ryazan, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Tomsk, , Russia

Tver', , Russia

Ulyanovsk, , Russia

Vladimir, , Russia

Yaroslavl, , Russia

Córdoba, , Spain

Getafe, , Spain

Seville, , Spain

Chernihiv, , Ukraine

Dnipropetrovsk, , Ukraine

Kharkiv, , Ukraine

Khmelnitsky, , Ukraine

Kryvyi Rih, , Ukraine

Kyiv, , Ukraine

Lviv, , Ukraine

Odesa, , Ukraine

Poltava, , Ukraine

Sumy, , Ukraine

Ternopil, , Ukraine

Uzhhorod, , Ukraine

Vinnytsia, , Ukraine

Zaporizhzhia, , Ukraine

Countries

Argentina; Brazil; Estonia; Latvia; United States; Australia; Belarus; Canada; Germany; Hungary; Lithuania; Poland; Romania; Russia; Spain; Ukraine

References

Husni ME, Deodhar A, Schwartzman S, Chakravarty SD, Hsia EC, Leu JH, Zhou Y, Lo KH, Kavanaugh A. Pooled safety results across phase 3 randomized trials of intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Arthritis Res Ther. 2022 Mar 21;24(1):73. doi: 10.1186/s13075-022-02753-6.

Reference Type: DERIVED

PMID: 35313978 (View on PubMed)

Mease P, Husni ME, Kafka S, Chakravarty SD, Harrison DD, Lo KH, Xu S, Hsia EC, Kavanaugh A. Inhibition of radiographic progression across levels of composite index-defined disease activity in patients with active psoriatic arthritis treated with intravenous golimumab: results from a phase-3, double-blind, placebo-controlled trial. Arthritis Res Ther. 2020 Mar 6;22(1):43. doi: 10.1186/s13075-020-2126-1.

Reference Type: DERIVED

PMID: 32143685 (View on PubMed)

Husni ME, Kavanaugh A, Murphy F, Rekalov D, Harrison DD, Kim L, Lo KH, Leu JH, Hsia EC. Efficacy and Safety of Intravenous Golimumab Through One Year in Patients With Active Psoriatic Arthritis. Arthritis Care Res (Hoboken). 2020 Jun;72(6):806-813. doi: 10.1002/acr.23905. Epub 2020 May 15.

Reference Type: DERIVED

PMID: 30980514 (View on PubMed)

Kavanaugh A, Husni ME, Harrison DD, Kim L, Lo KH, Noonan L, Hsia EC. Radiographic Progression Inhibition with Intravenous Golimumab in Psoriatic Arthritis: Week 24 Results of a Phase III, Randomized, Double-blind, Placebo-controlled Trial. J Rheumatol. 2019 Jun;46(6):595-602. doi: 10.3899/jrheum.180681. Epub 2019 Feb 15.

Reference Type: DERIVED

PMID: 30770519 (View on PubMed)

Kavanaugh A, Husni ME, Harrison DD, Kim L, Lo KH, Leu JH, Hsia EC. Safety and Efficacy of Intravenous Golimumab in Patients With Active Psoriatic Arthritis: Results Through Week Twenty-Four of the GO-VIBRANT Study. Arthritis Rheumatol. 2017 Nov;69(11):2151-2161. doi: 10.1002/art.40226.

Reference Type: DERIVED

PMID: 28805045 (View on PubMed)

Other Identifiers

2014-000242-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNTO148PSA3001

Identifier Type: OTHER

Identifier Source: secondary_id

CR103796

Identifier Type: -

Identifier Source: org_study_id