A Long Term Safety Extension Study (CHS-0214-05)

Coherus BioSciences

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis; Rheumatoid Arthritis

Treatments: Drug: CHS-0214

Study type: Interventional

Funder types: Industry

Identifiers

NCT02486939

CHS-0214-05

Details and patient eligibility

About

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.

Enrollment: 359 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• None

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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359 participants in 1 patient group

CHS-0214

Experimental group

Description:

CHS-0214 50 mg weekly

Treatment:

Drug: CHS-0214