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Trial record 3 of 3 for:    psoriasis coherus

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02486939
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Collaborators:
Daiichi Sankyo Co., Ltd.
Shire
Information provided by (Responsible Party):
Coherus Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Plaque Psoriasis Drug: CHS-0214 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 359 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Safety Extension Study (OLSES) Evaluating the Long Term Safety and Durability of Response of CHS-0214 (CHS-0214-05)
Study Start Date : July 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: CHS-0214
CHS-0214 50 mg weekly
Drug: CHS-0214
Open label




Primary Outcome Measures :
  1. Durability of Response (Maintenance of an ACR20 Response or Greater), Which Was Measured at Each Visit in Subjects of RA [ Time Frame: 48 Weeks ]

    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).


  2. In Subjects With PsO, Durability of Response (Maintenance of PASI-50 Response or Greater), Which Was Measured at Each Visit. [ Time Frame: Week 0,4,12,24,36,48 ]
    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.


Secondary Outcome Measures :
  1. 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. [ Time Frame: 108 Weeks ]
    The DAS28-CRP(4) is a composite score (ranging from 0 to 9.4) calculated using the results of the TJC (using a 28 joint subset), SJC (using a 28 joint subset), hs-CRP level (mg/L), and SGA (0 to 100 scale). The DAS28-CRP(4) was calculated using the following formula:0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014* SGA + 0.96. For DAS28-CRP(4), scores indicating high disease activity are >5.1; low disease activity are <3.2;and remission are <2.6.

  2. DAS28-CRP(4) <2.6 (ie, Remission) on All Visits After DAS28-CRP(4) <2.6 Was Achieved for Subjects With RA. [ Time Frame: 48 Weeks ]

    The DAS28-CRP(4) is a composite score (ranging from 0 to 9.4) calculated using the results of the TJC (using a 28 joint subset), SJC (using a 28 joint subset), hs-CRP level (mg/L), and SGA (0 to 100 scale). The DAS28-CRP(4) was calculated using the following formula:0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014* SGA + 0.96.

    For DAS28-CRP(4), scores indicating high disease activity are >5.1; low disease activity are <3.2;and remission are <2.6.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486939


Locations
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Japan
Oribe Clinic of Rheumatism and Medicine
Oita, Ōita Prefecture, Japan, 870-0823
Sponsors and Collaborators
Coherus Biosciences, Inc.
Daiichi Sankyo Co., Ltd.
Shire
Investigators
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Study Director: Barbara Finck, MD Coherus Biosciences, Inc.
  Study Documents (Full-Text)

Documents provided by Coherus Biosciences, Inc.:
Study Protocol  [PDF] February 29, 2016
Statistical Analysis Plan  [PDF] October 25, 2017

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Responsible Party: Coherus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02486939    
Other Study ID Numbers: CHS-0214-05
First Posted: July 1, 2015    Key Record Dates
Results First Posted: December 27, 2018
Last Update Posted: December 27, 2018
Last Verified: November 2017
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases