ECLIPSE 2019.
Study characteristics | ||
Methods | RCT, active‐controlled, double‐blind study Date of study: April 2017‐ September 2018 Location: world‐wide (142 sites) Phase 3 |
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Participants |
Randomised: 1048 participants Inclusion criteria
Exclusion criteria
Baseline characteristics N = 1048, mean age of 46 years and 67% men Dropouts and withdrawals
Guselkumab 100 group (27), Secukinumab 300 group (48)
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Interventions |
Intervention A. Guselkumab 100mg (TREMFYA) S.C injection plus placebo (one injection) at weeks 0, 4, 12, and every 8 weeks thereafter until week 44, n=534 Control intervention B. Secukinumab 300mg (COSENTYX) administered as two 150mg S.C injections at weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until week 44, n=514 |
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Outcomes |
At week 48 Primary outcome
Secondary outcomes
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Notes | Funding: Quote (p831):"This study was funded by Janssen Research & Development." Conflict of interest: " Quote (p838): "KR has served as an advisor and paid speaker and has participated in clinical trials for AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Celgene, Covagen, Forward Pharma, Fresenius Medical Care, GlaxoSmithKline, Janssen, Janssen‐Cilag, Kyowa Kirin, LEO Pharma, Eli Lilly, Medac, Merck Sharp & Dohme, Novartis, Miltenyi Biotech, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB, Valeant, XBiotech, and Xenoport. AWA has served as a consultant, research investigator, speaker, or data safety board member for AbbVie, Boehringer Ingelheim/Parexel, Bristol‐Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Genentech, GlaxoSmithKline, Janssen, Janssen‐Ortho, Kyowa Hakko Kirin, LEO Pharma, Menlo Therapeutics, Merck, Modernizing Medicine, Novartis Pharmaceutical Corp, Ortho Dermatologics, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, Science 37, UCB Pharma, and Valeant. RGL has served as principle investigator, as a speaker, and on the scientific advisory board for and received compensation in the form of honoraria from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Janssen, LEO Pharma, Eli Lilly, Merck, Novartis, Pizer, Sun, and UCB Pharma. SF, BR, SL, M‐CH, and PB are all employees of Janssen Research & Development and own stock in Johnson & Johnson, of which Janssen is a subsidiary. AB has served as a scientific advisor or clinical study investigator for AbbVie, Aclaris, Allergan, Almirall, Amgen, Arena, Boehringer Ingelheim, Bristol‐Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, FLX Bio, Galderma, Genentech/Roche, GlaxoSmithKline, Janssen, LEO Pharma, Meiji, Merck Sharp & Dohme, Novartis, Pfizer, Purdue Pharma, Regeneron, Revance, Sandoz, Sanofi Genzyme, Sienna Pharmaceuticals, Sun Pharma, UCB Pharma, Valeant, and Vidac, and as a paid speaker for Janssen, Regeneron, and Sanofi Genzyme." |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote (p833): "Patients were randomly assigned (1:1) to receive either guselkumab or secukinumab. An outside vendor (Paraxel, Waltham, MA, USA) used an interactive web response system to randomly assign patients based on computer‐ generated permuted blocks." Comment: probably done |
Allocation concealment (selection bias) | Low risk | Quote (p833): "An outside vendor (Paraxel, Waltham, MA, USA) used an interactive web response system to randomly assign patients based on computer‐ generated permuted blocks." Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote (p832, 833):"A phase 3, multicentre, randomised, double‐blind, comparator‐controlled study (ECLIPSE)... ." "Patients, investigators, and the funder of the study were masked throughout the 56‐week database lock, with the exception of the unmasked site personnel who dispensed or administered the study agent." Comment: unclear if the process guarented blinding of participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote (p832, 833):"A phase 3, multicentre, randomised, double‐blind, comparator‐controlled study (ECLIPSE)... ." "Patients, investigators, and the funder of the study were masked throughout the 56‐week database lock, with the exception of the unmasked site personnel who dispensed or administered the study agent." Comment: unsure that the process guarented the blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dealing with missing data: Quote (p834, 835):" For efficacy analyses, we included all patients according to the random treatment allocation (intention‐to‐treat [ITT] population), regardless of the treatment received... Patients with missing data were considered non‐ responders (non‐responder imputation)." Randomly assigned 1048, analysed 1048 |
Selective reporting (reporting bias) | Low risk | Comment: the protocol for the study was available on ClinicalTrials.gov (NCT03090100). The prespecified outcomes and those mentioned in the Methods section appeared to have been reported. Results are posted on ClinicalTrials.gov. |