Overview

This trial is active, not recruiting.

Conditions rheumatoid arthritis, plaque psoriasis
Treatment chs-0214
Phase phase 3
Sponsor Coherus Biosciences, Inc.
Collaborator Daiichi Sankyo Co., Ltd.
Start date July 2015
End date September 2017
Trial size 359 participants
Trial identifier NCT02486939, CHS-0214-05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
CHS-0214 50 mg weekly
chs-0214
Open label

Primary Outcomes

Measure
Longer-term safety assessed by incidence of adverse events, changes in safety laboratory parameters, vital signs, physical examinations and assessment of immunogenicity
time frame: Up to 115 weeks

Secondary Outcomes

Measure
For subjects with RA, maintenance of at least an ACR20
time frame: Up to 115 weeks
For subjects with PsO, maintenance of at least PASI-50
time frame: Up to 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Have completed 48 weeks of evaluations in CHS-0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS-0214-04 and, at Week 48, had at least a PASI-50 Exclusion Criteria:

Additional Information

Official title An Open-Label Safety Extension Study (OLSES) Evaluating the Long Term Safety and Durability of Response of CHS-0214 (CHS-0214-05)
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Coherus Biosciences, Inc..