COSMOS: Guselkumab vs Placebo in Psoriatic Arthritis
Research type
Research Study
Full title
Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants with Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy
IRAS ID
257213
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen-Cilag International N.V
Eudract number
2018-003214-41
Clinicaltrials.gov Identifier
40547, CPMS ID Number
Duration of Study in the UK
2 years, 1 months, 2 days
Research summary
This is a research study in 245 adults with Psoriatic Arthritis (PsA). PsA is an inflammatory joint disease affecting a variety of joints including the fingers and toes. It affects men and women equally, causing joints to become swollen which results in stiffness, pain and lack of movement in the areas that are affected.
PsA is estimated to affect between 6-42% of the those already diagnosed with a form of psoriasis. Despite advances in the treatment options for PsA, there remains an unmet medical need for novel therapeutic agents which can clinically treat this condition and offer an improved benefit/risk profile for the patients.
Guselkumab (marketed as TREMFYA for the treatment of plaque psoriasis) has shown in previous studies that it is safe and effective in the treatment of patients with PsA. These studies mostly included biologic-naive patients, so this study is designed to further investigate if guselkumab is safe and effective in reducing PsA signs and symptoms in patients who have had an inadequate response to anti-TNFα therapy previously.
This study will last for a maximum of 62 weeks and is divided into 3 parts:
Screening Phase: 1 or more visits (upto 6 weeks)
Treatment Phase: 11 visits (48 weeks)
Safety Follow-Up Phase: 1 visit (8 weeks)During these visits a variety of tests will be carried out. These tests include, but are not limited to, blood pressure, ECG, physical exam, questionnaires and blood samples. Patients will be randomly assigned (like flipping a coin) to receive either guselkumab or placebo for the first 24 weeks. After Week 24 all patients will receive guselkumab until the end of the treatment phase. If at week 16, a patient is not showing sufficient improvement then there is the option to start treatment with guselkumab early.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0040
Date of REC Opinion
1 Mar 2019
REC opinion
Further Information Favourable Opinion