A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Samsung Bioepis Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01895309

First received: July 3, 2013

Last updated: July 13, 2016

Last verified: December 2015

History of Changes

Results First Received: July 13, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Interventions:	Drug: Enbrel (etanercept) Drug: SB4 (proposed biosimilar to etanercept)

Participant Flow

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Recruitment Details

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
SB4 (Proposed Biosimilar to Etanercept)	SB4 50 mg/week via subcutaneous injection
Enbrel (Etanercept)	Enbrel 50 mg/week via subcutaneous injection

Participant Flow: Overall Study

	SB4 (Proposed Biosimilar to Etanercept)	Enbrel (Etanercept)
STARTED	299	297
COMPLETED	259	246
NOT COMPLETED	40	51
Adverse Event	13	17
Protocol Violation	1	0
Lack of Efficacy	1	3
Lost to Follow-up	1	3
Physician Decision	15	10
Withdrawal by Subject	9	18

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
SB4 (Proposed Biosimilar to Etanercept)	SB4 50 mg/week via subcutaneous injection
Enbrel (Etanercept)	Enbrel 50 mg/week via subcutaneous injection
Total	Total of all reporting groups

Baseline Measures

	SB4 (Proposed Biosimilar to Etanercept)	Enbrel (Etanercept)	Total
Overall Participants Analyzed [Units: Participants]	299	297	596

Age [Units: Years] Mean (Standard Deviation)	52.1 (11.72)	51.6 (11.63)	51.8 (11.67)

Gender [Units: Participants]
Female	249	253	502
Male	50	44	94

Outcome Measures

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1. Primary:

American College of Rheumatology 20% Response Criteria (ACR20) [ Time Frame: Week 24 ]

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2. Secondary:

ACR20 [ Time Frame: Week 52 ]

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3. Secondary:

American College of Rheumatology 50% Response Criteria (ACR50) [ Time Frame: Week 24, Week 52 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. If the Sponsor requests, the Site shall remove any Confidential Information (other than Study results) prior to submitting or presenting the materials.

Results Point of Contact:

Name/Title: Director, Clinical Development
Organization: Samsung Bioepis
phone: +82 31 8061 4534

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Emery P, Vencovský J, Sylwestrzak A, Leszczyński P, Porawska W, Baranauskaite A, Tseluyko V, Zhdan VM, Stasiuk B, Milasiene R, Barrera Rodriguez AA, Cheong SY, Ghil J. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017 Jan;76(1):51-57. doi: 10.1136/annrheumdis-2015-207588. Epub 2015 Jul 6.

Responsible Party:	Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01895309 History of Changes
Other Study ID Numbers:	SB4-G31-RA
Study First Received:	July 3, 2013
Results First Received:	July 13, 2016
Last Updated:	July 13, 2016

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