At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 359 enrolled
Drug / intervention
CHS-0214drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Safety Extension Study (OLSES) Evaluating the Long Term Safety and Durability of Response of CHS-0214 (CHS-0214-05)
In Brief
A Phase 3 clinical trial evaluating CHS-0214 for Rheumatoid Arthritis and Plaque Psoriasis. Completed, enrolled 359 participants across 1 site.
Detailed Summary
An Open-label, Safety Extension Study (OLSES) evaluating the longer-term safety and durability of response of subjects who completed 48 weeks of evaluations in the confirmatory safety and efficacy studies, CHS 0214-02 or CHS-0214-04, evaluating CHS-0214 in patients with rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis, Plaque Psoriasis
CountriesJapan
CollaboratorsDaiichi Sankyo Co., Ltd., Shire
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartJul 2015
Primary CompletionSep 2017
Study CompletionOct 2017
TodayJul 2026
First PostedJul 1, 2015
Enrollment StartJul 1, 2015
Primary CompletionSep 1, 2017
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.0 years ago
Interventions
CHS-0214drug
Open label