Coherus Open-Label Safety Extension Study

An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000665-30-GB

Enrollment

447

Registered

2015-05-20

Start date

2015-07-30

Completion date

Unknown

Last updated

2018-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Chronic Plaque Psoriasis MedDRA version: 18.0 Level: LLT Classification code 10042952 Term: Systemic rheumatoid arthritis System Organ Class: 100000004859 MedDRA version: 18.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858

Interventions

Product Code: CHS-0214 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etanercept CAS Number: 185243-69-0 Current Sponsor code: CHS-0214 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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; 2. Women who either: a) Are of childbearing potential with a negative urine pregnancy test at Week 0 Day 0 who agree to use 1 or more approved methods of birth control (hormonal contraception, intrauterine device, diaphragm plus spermicide, condom plus spermicide, or abstinence from heterosexual intercourse—abstinence from heterosexual intercourse will be acceptable only if it is the preferred and usual lifestyle of the subject regardless of study participation; abstinence should be practiced for the duration of the study Follow-up Visit 28 days after the last dose of study drug); b) Have been postmenopausal for at least 2 years (with amenorrhea for at least 1 year) or have had a hysterectomy, bilateral salpingo oophorectomy, or tubal ligation prior to signing the informed consent; and 3. Able and willing to give written informed consent prior to performance of any study related procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 57

Exclusion criteria

Exclusion criteria: 1. Men whose partners may become pregnant (do not agree to use contraception or who are not postmenopausal) or who may breastfeed during the study (Japan only specific exclusion).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate 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 rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.;Secondary Objective: N/A;Primary end point(s): SAFETY: Safety will be assessed by: • Assessment of treatment-emergent AEs; • Determination of subject withdrawal information; • Assessment of injection site reactions; • Assessment of changes in safety laboratory parameters, including hematology, clinical chemistry, and pregnancy tests; • Assessment of changes in vital signs, physical examination, and electrocardiogram findings; • Monitoring for tuberculosis (TB) with regular QuantiFERON®-TB Gold test (every 12 months or more frequently for regions with high incidences of TB or to evaluate signs and symptoms that might be due to TB); and • Assessment of immunogenicity (anti-CHS 0214 antibodies) EFFICACY: Durability of response will be measured as follows: • For subjects with RA, maintenance of an ACR20 response or greater • For subjects with PsO, maintenance of PASI-50 response or greater ;Timepoint(s) of evaluation of this end point: SAFTEY: At 1 month and 3 months following enrollment and every 3 months thereafter EFFICACY: At each visit	—

Measure

Time frame

Main Objective: To evaluate 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 rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively.;Secondary Objective: N/A;Primary end point(s): SAFETY: Safety will be assessed by: • Assessment of treatment-emergent AEs; • Determination of subject withdrawal information; • Assessment of injection site reactions; • Assessment of changes in safety laboratory parameters, including hematology, clinical chemistry, and pregnancy tests; • Assessment of changes in vital signs, physical examination, and electrocardiogram findings; • Monitoring for tuberculosis (TB) with regular QuantiFERON®-TB Gold test (every 12 months or more frequently for regions with high incidences of TB or to evaluate signs and symptoms that might be due to TB); and • Assessment of immunogenicity (anti-CHS 0214 antibodies) EFFICACY: Durability of response will be measured as follows: • For subjects with RA, maintenance of an ACR20 response or greater • For subjects with PsO, maintenance of PASI-50 response or greater ;Timepoint(s) of evaluation of this end point: SAFTEY: At 1 month and 3 months following enrollment and every 3 months thereafter EFFICACY: At each visit

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Secondary

Measure	Time frame
Secondary end point(s): EFFICACY: For subjects with RA, Disease Activity Score using 28 tender and swollen joint counts, high sensitivity C reactive protein, and subject’s global assessment (DAS28-CRP [4]) to < 3.2 (low disease activity) assessed at all visits and < 2.6 (remission) assessed on all visits after DAS28-CRP (4) < 2.6 is achieved Retained Samples: Serum samples will be collected at each visit and retained for potential analysis of serum concentration of CHS 0214, anti-drug antibodies, or other tests as necessary to evaluate AEs, loss of response, or compliance. Serum samples will not be used to assess population pharmacokinetics (PK), biomarkers, or genetics. Samples will be stored at Medpace Reference Laboratory, LLC (MRL) and may be transferred to Charles River Laboratories or other reference laboratory for analysis at the request of the Sponsor. All retained samples and remnants of samples will be destroyed 2 years after the completion of the study (data base lock).;Timepoint(s) of evaluation of this end point: EFFICACY: At all visits. Retained Samples: Up to 2 years after completion of the study (data base lock).	—

Measure

Time frame

Secondary end point(s): EFFICACY: For subjects with RA, Disease Activity Score using 28 tender and swollen joint counts, high sensitivity C reactive protein, and subject’s global assessment (DAS28-CRP [4]) to < 3.2 (low disease activity) assessed at all visits and < 2.6 (remission) assessed on all visits after DAS28-CRP (4) < 2.6 is achieved Retained Samples: Serum samples will be collected at each visit and retained for potential analysis of serum concentration of CHS 0214, anti-drug antibodies, or other tests as necessary to evaluate AEs, loss of response, or compliance. Serum samples will not be used to assess population pharmacokinetics (PK), biomarkers, or genetics. Samples will be stored at Medpace Reference Laboratory, LLC (MRL) and may be transferred to Charles River Laboratories or other reference laboratory for analysis at the request of the Sponsor. All retained samples and remnants of samples will be destroyed 2 years after the completion of the study (data base lock).;Timepoint(s) of evaluation of this end point: EFFICACY: At all visits. Retained Samples: Up to 2 years after completion of the study (data base lock).

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Countries

Australia, Canada, France, Germany, Israel, Italy, Japan, South Africa, Spain, United Kingdom

Contacts

Public ContactDirector of Regulatory Submissions

Medpace UK

b.mcdougall@medpace.com00447825587853

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026