A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/27/2019 |
Start Date: | July 12, 2017 |
End Date: | December 8, 2020 |
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis
The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in
participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and
symptoms of PsA.
participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and
symptoms of PsA.
This is a study of guselkumab in participants with active PsA who are biologically naive and
have had inadequate response to standard therapies. It will evaluate the clinical efficacy of
guselkumab in the reduction of signs and symptoms, structural damage inhibition and the
safety profile of guselkumab in the treatment of PsA. The study will consist of a screening
phase (up to 6 weeks), a blinded treatment phase (approximately 100 weeks) including a
placebo controlled period from Week 0 to Week 24 and an active treatment period from Week 24
to Week 100 and a safety follow-up phase of 12 weeks after the last administration of study
agent. Efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and
pharmacogenomics evaluations will be performed in the study at defined schedule.
have had inadequate response to standard therapies. It will evaluate the clinical efficacy of
guselkumab in the reduction of signs and symptoms, structural damage inhibition and the
safety profile of guselkumab in the treatment of PsA. The study will consist of a screening
phase (up to 6 weeks), a blinded treatment phase (approximately 100 weeks) including a
placebo controlled period from Week 0 to Week 24 and an active treatment period from Week 24
to Week 100 and a safety follow-up phase of 12 weeks after the last administration of study
agent. Efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and
pharmacogenomics evaluations will be performed in the study at defined schedule.
Inclusion Criteria:
- Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the first
administration of study agent and meet Classification criteria for Psoriatic Arthritis
(CASPAR) at screening
- Have active PsA as defined by: at least 5 swollen joints and at least 5 tender joints
at screening and at baseline, and CRP greater than or equal to (>=) 0.6 milligram per
deciLitre (mg/dL) at screening from the central laboratory
- Have 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
(confirmation of sacroiliitis should be performed at the screening visit by a locally
performed pelvic x-ray [single anterior-posterior view] unless a pelvic or SI joint
x-ray or pelvic magnetic resonance imaging (MRI) has been previously performed.
Results must be documented)
- Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter
(cm) diameter or nail changes consistent with psoriasis or documented history of
plaque psoriasis
- Have active PsA despite previous non-biologic disease-modifying antirheumatic drug
(DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
Exclusion Criteria:
- Has other inflammatory diseases that might confound the evaluations or benefit of
guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial
spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis),
systemic lupus erythematosus, or Lyme disease
- Has previously received any biologic treatment
- Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K),
decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor
- Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6
thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4
weeks of the first administration of study agent
- Is currently receiving 2 or more non-biologic DMARDs (other than methotrexate [MTX],
sulfasalazine [SSZ], Hydroxychloroquine [HCQ], leflunomide [LEF]) including, but not
limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the
first administration of study agent
- Has received apremilast within 4 weeks prior to the first administration of study
agent
We found this trial at
9
sites
University of Michigan The University of Michigan was founded in 1817 as one of the...
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