Psoriasis Clinical Trial

A Study of Golimumab in Participants With Active Psoriatic Arthritis

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).

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Full 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.

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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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

480

Study ID:

NCT02181673

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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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

Saint 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

Gomel , , Belarus

Grodno , , Belarus

Minsk , , Belarus

Vitebsk , , Belarus

Saint-John'S Newfoundland and Labrador, , Canada

Waterloo Ontario, , Canada

Burlington , , Canada

Bad Doberan , , Germany

Berlin , , Germany

Erfurt , , Germany

Hamburg , , Germany

Köln , , Germany

Ratingen , , Germany

Zerbst , , Germany

Balatonfured , , Hungary

Budapest , , Hungary

Debrecen , , Hungary

Heviz , , Hungary

Kistarcsa , , Hungary

Nyiregyhaza , , Hungary

Szombathely , , Hungary

Alytus , , Lithuania

Kaunas , , Lithuania

Klaipeda , , Lithuania

Siauliai , , Lithuania

Vilnius , , Lithuania

Bydgoszcz , , Poland

Bytom , , Poland

Czestochowa , , Poland

Krakow , , Poland

Lublin , , Poland

Nadarzyn , , Poland

Nowa Sól , , Poland

Poznan , , Poland

Warszawa , , Poland

Wroclaw , , Poland

Bucuresti , , Romania

Constanta , , Romania

Iasi , , Romania

Ploiesti , , Romania

Kemerovo , , Russian Federation

Korolev , , Russian Federation

Krasnoyarsk , , Russian Federation

Kursk , , Russian Federation

Moscow , , Russian Federation

Novosibirsk , , Russian Federation

Orenburg , , Russian Federation

Petrozavodsk , , Russian Federation

Ryazan , , Russian Federation

Saint Petersburg , , Russian Federation

Saint-Petersburg , , Russian Federation

Saratov , , Russian Federation

Tomsk , , Russian Federation

Tver , , Russian Federation

Ulyanovsk , , Russian Federation

Vladimir , , Russian Federation

Yaroslavl , , Russian Federation

Cordoba , , Spain

Getafe , , Spain

Sevilla , , Spain

Chernihiv , , Ukraine

Dnipropetrovsk , , Ukraine

Kharkiv , , Ukraine

Khmelnitsky , , Ukraine

Kryvyi Rih , , Ukraine

Kyiv , , Ukraine

Lviv , , Ukraine

Odessa , , Ukraine

Poltava , , Ukraine

Sumy , , Ukraine

Ternopil , , Ukraine

Uzhhorod , , Ukraine

Vinnytsia , , Ukraine

Zaporizhzhia , , Ukraine

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

480

Study ID:

NCT02181673

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

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