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).
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.
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
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There is 1 Location for this study
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
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