Psoriasis Clinical Trial
A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
Summary
The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.
Full Description
PsA is a chronic inflammatory multi-faceted disease that impacts the peripheral and axial joints, soft tissues, and skin. Guselkumab is a fully human monoclonal antibody (mAb) directed against the p19 subunit of interleukin (IL)-23, blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. Golimumab is a fully human anti-TNF-alpha mAb that binds to TNF-alpha with high affinity, prevents binding to its receptors, thereby inhibiting the biological activity of TNF-alpha and resulting in limited production or activity of inflammatory cytokines, thereby providing therapeutic benefit in various chronic inflammatory disorders, including PsA. This study will consist of a Screening Phase (up to 6 weeks), Double-blind Phase from Weeks 0 to 24 which includes the active treatment phase and the primary efficacy visit (Week 24), and Safety Follow-up Phase from Week 24 to Week 36. Key safety assessments will include adverse events (AEs), clinical laboratory safety tests (hematology and chemistry), vital signs, monitoring for injection-site and hypersensitivity reactions, and early detection of active tuberculosis (TB). The total duration of the study is up to 42 weeks.
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of psoriatic arthritis (PsA) for greater than or equal to (>=) 6 months prior to the first administration of study intervention and meet Classification criteria for PsA (CASPAR) criteria at screening
Have active PsA as defined by having at least 3 swollen joints and at least 3 tender joints at screening and at baseline
Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Have active plaque psoriasis, with at least one psoriatic plaque of >=2 centimeter (cm) diameter or nail changes consistent with psoriasis
Have an inadequate response (IR) to anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapy, defined as presence of active PsA despite treatment with either 1 or 2 prior anti-TNF-alpha agent(s) and the following: a. Lack of benefit to either 1 or 2 prior anti-TNF-alpha therapies, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, or certolizumab pegol therapy, or at least 14-weeks of infliximab, or any biosimilar of these 4 therapies. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; b. The last dose of anti-TNF-alpha therapy must have occurred greater than 5 half-lives of the drug prior to first study intervention administration (washout period)
Exclusion Criteria:
Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr AxSpA), systemic lupus erythematosus, or lyme disease
Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies (mAb), or antibody fragments
Has received prior treatment with golimumab or guselkumab or has documented intolerance to prior anti-TNF-alpha therapy in the participant history by the treating physician
Has received more than 2 prior anti-TNF-alpha agents (or biosimilars)
Positive human immunodeficiency virus (HIV) antibody test
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There are 82 Locations for this study
Phoenix Arizona, 85032, United States
Phoenix Arizona, 85037, United States
Searcy Arkansas, 72143, United States
Avon Park Florida, 33825, United States
Bay Pines Florida, 33744, United States
DeBary Florida, 32713, United States
Miami Florida, 33136, United States
Ocoee Florida, 34761, United States
Ormond Beach Florida, 32174, United States
Marietta Georgia, 30060, United States
Lansing Michigan, 48911, United States
Springfield Missouri, 65807, United States
Bronx New York, 10461, United States
Brooklyn New York, 11201, United States
New York New York, 10016, United States
Rochester New York, 14642, United States
Vandalia Ohio, 45377, United States
Plano Texas, 75024, United States
Tomball Texas, 77375, United States
Seattle Washington, 98122, United States
Frederiksberg , 2000, Denmark
Glostrup , 2600, Denmark
Køge , 4600, Denmark
Silkeborg , 8600, Denmark
Vejle , 7100, Denmark
Le Mans , 72037, France
Toulouse Cedex 9 , 31059, France
Tours , 37044, France
Budapest , 1036, Hungary
Gyula , 5700, Hungary
Szekesfehervar , 8000, Hungary
Veszprem , 8200, Hungary
Cagliari , 09124, Italy
Milano , 20122, Italy
Milano , 20132, Italy
Pavia , 27100, Italy
Reggio Emilia , 42123, Italy
Roma , 00133, Italy
Roma , 00168, Italy
Rome , 00128, Italy
Torino , 10128, Italy
Elblag , 82-30, Poland
Lodz , 90-24, Poland
Nadarzyn , 05-83, Poland
Poznan , 61-11, Poland
Warsaw , 00-87, Poland
Warszawa , 03-29, Poland
Wrocław , 51-68, Poland
Kemerovo , 65000, Russian Federation
Kemerovo , 65007, Russian Federation
Korolev , 14106, Russian Federation
Moscow , 12911, Russian Federation
Orenburg , 46000, Russian Federation
Rostov , 34400, Russian Federation
Ryazan , 39004, Russian Federation
Smolensk , 21402, Russian Federation
St. Petersburg , 19415, Russian Federation
Ufa , 45000, Russian Federation
Yaroslavl , 15000, Russian Federation
A Coruña , 15006, Spain
Barcelona , 08916, Spain
Bilbao , 48013, Spain
Córdoba , 14004, Spain
Madrid , 28041, Spain
Sabadell , 08208, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41009, Spain
Sevilla , 41010, Spain
Sevilla , 41014, Spain
Malmo , 205 0, Sweden
Solna , 171 7, Sweden
Kharkiv , 61039, Ukraine
Kharkiv , 61204, Ukraine
Kyiv , 03037, Ukraine
Kyiv , 03049, Ukraine
Kyiv , 03680, Ukraine
Kyiv , 04107, Ukraine
Poltava , 36011, Ukraine
Ternopil , 46002, Ukraine
Uzhgorod , 88000, Ukraine
Vinnytsia , 21009, Ukraine
Zaporizhzhya , 69600, Ukraine
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