Trial record 3 of 7 for: SB2 samsung

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A Study Comparing SB2 to Remicade® 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:

NCT01936181

First received: September 2, 2013

Last updated: July 13, 2016

Last verified: November 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: Remicade (infliximab) Drug: SB2 (proposed biosimilar to infliximab)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
SB2 (Proposed Biosimilar to Inflixmab)	SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70 SB2 (proposed biosimilar to infliximab)
Remicade (Infliximab)	Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46 At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.
Remicade (Infliximab), Switch to SB2	SB2 3mg/kg at week 54, 62, 70 SB2 (proposed biosimilar to infliximab)
Remicade (Infliximab), Continue as Remicade	Remicade 3mg/kg at week 54, 62, 70 Remicade (infliximab)

Participant Flow for 2 periods

Period 1: Randomised, Double-blind

	SB2 (Proposed Biosimilar to Inflixmab)	Remicade (Infliximab)
STARTED	291	293
COMPLETED	227	225
NOT COMPLETED	64	68
Adverse Event	27	21
Protocol Violation	1	5
Lack of Efficacy	5	6
Lost to Follow-up	0	1
Pregnancy	0	1
Physician Decision	4	4
Withdrawal by Subject	23	26
Subjects from Eastern Ukraine sites	4	4

Period 2: Transition-extension

	SB2 (Proposed Biosimilar to Inflixmab)	Remicade (Infliximab), Switch to SB2	Remicade (Infliximab), Continue as Remicade
STARTED	201	94	101
COMPLETED	186	88	96
NOT COMPLETED	15	6	5
Adverse Event	3	3	1
Lost to Follow-up	3	1	2
Physician Decision	2	0	1
Withdrawal by Subject	7	2	1

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

SB2 (Proposed Biosimilar to Inflixmab)

SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70

SB2 (proposed biosimilar to infliximab)

Remicade (Infliximab)

Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46

At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70.

Total

Total of all reporting groups

Baseline Measures

	SB2 (Proposed Biosimilar to Inflixmab)	Remicade (Infliximab)	Total
Overall Participants Analyzed [Units: Participants]	291	293	584

Age [Units: Years] Mean (Standard Deviation)	51.6 (11.92)	52.6 (11.74)	52.1 (11.83)

Gender [Units: Participants]
Female	232	236	468
Male	59	57	116

Outcome Measures

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1. Primary:

American College of Rheumatology 20% Response Criteria (ACR20) [ Time Frame: Week 30 ]

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2. Secondary:

ACR20 [ Time Frame: Week 54, Week 78 ]

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3. Secondary:

American College of Rheumatology 50% Response Criteria (ACR50) [ Time Frame: Week 30, Week 54, Week 78 ]

Results not yet reported. Anticipated Reporting Date: No text entered.

4. Secondary:

Disease Activity Score Based on a 28 Joint Count (DAS28) [ Time Frame: Week 30, Week 54, Week 78 ]

Results not yet reported. Anticipated Reporting Date: No text entered.

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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):

Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Choi J, Rho YH, Smolen JS. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017 Jan;76(1):58-64. doi: 10.1136/annrheumdis-2015-207764. Epub 2015 Aug 28.

Responsible Party:	Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01936181 History of Changes
Other Study ID Numbers:	SB2-G31-RA
Study First Received:	September 2, 2013
Results First Received:	July 13, 2016
Last Updated:	July 13, 2016

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