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

NCT02486939 | Completed Phase 3 Results DMC

• 1 other identifier: CHS-0214-05
• Study Type: interventional
• Target: 359
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis; Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Durability of Response (Maintenance of an ACR20 Response or Greater), Which Was Measured at Each Visit in Subjects of RA

  The ACR20 is a composite endpoint based on the following assessments: 66/68 swollen joint count (SJC) or tender joint count (TJC), Subject's pain assessment (SPA)-visual analog scale (VAS),Subject's global assessment of disease activity (SGA)-VAS,Physician's global assessment of disease activity (PGA)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and High sensitivity C-reactive protein (hs-CRP).The baseline value to assess the ACR20 during this study was the same baseline value used to assess the ACR20 during the parent study (ie, the Week 0 assessment in the parent study). Subjects were considered an ACR20 responder at a visit if compared to baseline in the parent study (CHS-0214-02) they achieved: At least 20% decrease in SJC, At least 20% decrease in TJC, and At least 20% improvement in at least 3 of the following 5 measures: C-reactive protein, HAQ-DI, SPA (using a VAS) for pain,SGA (using a VAS), orPGA (using a VAS).

  48 Weeks

• In Subjects With PsO, Durability of Response (Maintenance of PASI-50 Response or Greater), Which Was Measured at Each Visit.

  All PASI score assessors must have demonstrated proficiency at performing the PASI. Every attempt was made to use the same assessor for each subject throughout the study. n subjects with PsO, durability of response (maintenance of a PASI-50 response or greater at each assessment) was based on scoring the PsO lesions on a scale of 0 to 4 for 3 characteristics: erythema, induration, and desquamation, and within 4 anatomical regions: head, trunk, upper extremities, and lower extremities. Within each of these regions, the area of involvement was scored on a scale of 0 to 6, with the total score being a weighted average, and weights defined by the area of involvement. The clinician assessed the subject's PsO lesions according to the PASI and provided this score within the case report form at Weeks 0 (as the Week 48 assessment of the parent study), 4, 12, 24, 36, and 48. Subjects were classified as having a PASI-50 response based upon 50% reduction from baseline of the parent study.

  Week 0,4,12,24,36,48

Secondary Outcomes (2)

• Disease Activity Score Using 28 Tender and Swollen Joint Counts, High Sensitivity C-reactive Protein, and Subject's Global Assessment of Disease Activity (DAS28-CRP[4]) <3.2 (ie, Low Disease Activity) at All Visits for All Subjects With RA.

  108 Weeks

• DAS28-CRP(4) <2.6 (ie, Remission) on All Visits After DAS28-CRP(4) <2.6 Was Achieved for Subjects With RA.

  48 Weeks

Study Arms (1)

CHS-0214

EXPERIMENTAL

CHS-0214 50 mg weekly

Drug: CHS-0214

Interventions

CHS-0214 DRUG

Open label

CHS-0214

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Coherus Oncology, Inc.: lead
• Daiichi Sankyo Co., Ltd.: collaborator
• Shire: collaborator

Study Sites (1)

Oribe Clinic of Rheumatism and Medicine

Ōita, Oita Prefecture, 870-0823, Japan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Barbara K. Finck, MD Chief Medical Officer
• Organization: Coherus BioSciences, Inc

Bfinck@coherus.com

650-649-3529

Study Officials

• Barbara Finck, MD

  Coherus Oncology, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 1, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 27, 2018
• Results First Posted: December 27, 2018

Record last verified: 2017-11

Locations

JP (1)