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The European Union Clinical Trials Register allows you to search for protocol and results information on:

interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC

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EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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The EU Clinical Trials Register currently displays 43857 clinical trials with a EudraCT protocol, of which 7284 are clinical trials conducted with subjects less than 18 years old. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).

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Clinical Trial Results:
A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Summary
EudraCT number	2013-005013-13
Trial protocol	CZ LT PL BG
Global end of trial date	19 Oct 2015

Results information
Results version number	v1(current)
This version publication date	02 Nov 2016
First version publication date	02 Nov 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

SB5-G31-RA

ISRCTN number

-

US NCT number

-

WHO universal trial number (UTN)

-

Sponsor organisation name

Samsung Bioepis Co., Ltd.

Sponsor organisation address

107, Cheomdan-daero, Yeonsu-gu, Incheon, Korea, Republic of, 21987

Public contact

Information Desk, Samsung Bioepis Co., Ltd. , +82 324553114, bioepisinfo@samsung.com

Scientific contact

Information Desk, Samsung Bioepis Co., Ltd. , +82 324553114, bioepisinfo@samsung.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

19 Oct 2015

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

19 Oct 2015

Was the trial ended prematurely?

Yes

Main objective of the trial

The primary objective of this study is to demonstrate the equivalence of SB5 to Humira® atWeek 24, in terms of American College of Rheumatology 20% response criteria (ACR20) response rate in subjects with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.

Protection of trial subjects

The study and clinical study protocols were reviewed and approved by Independent Ethics Committee (IEC) or Institutional Review Board (IRB). This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki (2008) and that are consistent with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (ICH E6) and applicable local regulatory requirements and laws. The nature and purpose of the study was fully explained to each subject and written informed consent was obtained at Screening from each subject before any study related procedures were performed. The consent documents for the study was reviewed and approved by the appropriate IEC or IRB prior to use.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

12 May 2014

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

2 Months

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 216

Country: Number of subjects enrolled

Bulgaria: 51

Country: Number of subjects enrolled

Czech Republic: 90

Country: Number of subjects enrolled

Lithuania: 35

Country: Number of subjects enrolled

Bosnia and Herzegovina: 65

Country: Number of subjects enrolled

Korea, Republic of: 87

Worldwide total number of subjects

544

EEA total number of subjects

392

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

475

From 65 to 84 years

69

85 years and over

0

Subject disposition

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Recruitment details

-

Screening details

-

Number of subjects started

747 ^[1]

Number of subjects completed

544

Reason: Number of subjects

subject lost to follow up: 3

Reason: Number of subjects

Consent withdrawn by subject: 33

Reason: Number of subjects

Adverse event, non-fatal: 1

Reason: Number of subjects

Other: 6

Reason: Number of subjects

does not meet Inclusion/Exclusion Criteria: 160

Notes
[1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: the Sponsor used data from 'Randomised Set', not 'Enrolled Set' to fill in 'Population of trial subjects' section, thus the total worldwide subject number is same with the overall number of baseline participants. Screened(Pre-assignment) subjects: 747, Randomised subjects: 544.

Period 1 title

Randomised, Double-blind

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

SB5 (Proposed Biosimilar to Adalimumab)

Arm description

SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)

Arm type

Experimental

Investigational medicinal product name

SB5 (proposed adalimumab biosimilar)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects self-administered 40 mg of either SB5 or EU-sourced Humira® every other week, via subcutaneous injection, up to Week 50 (a total of 26 administrations of IP) unless they withdrew early from the study.

Humira (Adalimumab)

Arm description

Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.

Arm type

Active comparator

Investigational medicinal product name

Humira®

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects self-administered 40 mg of either SB5 or EU-sourced Humira® every other week, via subcutaneous injection, up to Week 50 (a total of 26 administrations of IP) unless they withdrew early from the study.

Number of subjects in period 1	SB5 (Proposed Biosimilar to Adalimumab)	Humira (Adalimumab)
Started	271	273
Completed	254	254
Not completed	17	19
Consent withdrawn by subject	11	8
Adverse event, non-fatal	2	9
Other	3	-
Lack of efficacy	1	2

Period 2 title

Transition-extension

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

SB5 (Proposed Biosimilar to Adalimumab)

Arm description

SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)

Arm type

Experimental

Investigational medicinal product name

SB5 (proposed adalimumab biosimilar)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects self-administered 40 mg of either SB5 or EU-sourced Humira® every other week, via subcutaneous injection, up to Week 50 (a total of 26 administrations of IP) unless they withdrew early from the study.

Humira (Adalimumab), Switch to SB5

Arm description

From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.

Arm type

Experimental

Investigational medicinal product name

SB5 (proposed adalimumab biosimilar)

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects self-administered 40 mg of either SB5 or EU-sourced Humira® every other week, via subcutaneous injection, up to Week 50 (a total of 26 administrations of IP) unless they withdrew early from the study.

Humira (Adalimumab), Continue as Humira

Arm description

From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.

Arm type

Active comparator

Investigational medicinal product name

Humira®

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects self-administered 40 mg of either SB5 or EU-sourced Humira® every other week, via ubcutaneous injection, up to Week 50 (a total of 26 administrations of IP) unless they withdrew early from the study.

Number of subjects in period 2	SB5 (Proposed Biosimilar to Adalimumab)	Humira (Adalimumab), Switch to SB5	Humira (Adalimumab), Continue as Humira
Started	254	125	129
Completed	248	117	124
Not completed	6	8	5
Consent withdrawn by subject	2	4	1
Adverse event, non-fatal	2	2	3
Other	1	1	-
Lost to follow-up	1	-	-
Lack of efficacy	-	1	1

Baseline characteristics

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Reporting group title

SB5 (Proposed Biosimilar to Adalimumab)

Reporting group description

SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)

Reporting group title

Humira (Adalimumab)

Reporting group description

Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.

Reporting group values	SB5 (Proposed Biosimilar to Adalimumab)	Humira (Adalimumab)	Total
Number of subjects	271	273	544
Age categorical
Units: Subjects
Adults (18-64 years)	242	233	475
From 65-84 years	29	40	69
Age continuous
Units: years
median (standard deviation)	51 ± 12.67	55 ± 11.91	-
Gender categorical
Units: Subjects
Female	217	224	441
Male	54	49	103

End points

Top of page

Reporting group title

SB5 (Proposed Biosimilar to Adalimumab)

Reporting group description

SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)

Reporting group title

Humira (Adalimumab)

Reporting group description

Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.

Reporting group title

SB5 (Proposed Biosimilar to Adalimumab)

Reporting group description

SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)

Reporting group title

Humira (Adalimumab), Switch to SB5

Reporting group description

From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.

Reporting group title

Humira (Adalimumab), Continue as Humira

Reporting group description

From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.

Primary: American College of Rheumatology 20% Response Criteria (ACR20) response rate in subjects

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End point title

American College of Rheumatology 20% Response Criteria (ACR20) response rate in subjects

End point description

End point type

Primary

End point timeframe

at Week 24

End point values	SB5 (Proposed Biosimilar to Adalimumab)	Humira (Adalimumab)
Number of subjects analysed	239	237
Units: number	173	171

Equivalence test

Comparison groups

Humira (Adalimumab) v SB5 (Proposed Biosimilar to Adalimumab)

Number of subjects included in analysis

476

Analysis specification

Pre-specified

Analysis type

equivalence

Method

Parameter type

Risk difference (RD)

Point estimate

0

Confidence interval

level

95%

sides

2-sided

lower limit

-0.15

upper limit

0.15

Variability estimate

Standard error of the mean

Secondary: American College of Rheumatology 20% Response Criteria (ACR20) response rate in subjects

Top of page

End point title

American College of Rheumatology 20% Response Criteria (ACR20) response rate in subjects

End point description

End point type

Secondary

End point timeframe

at Week 52

End point values	SB5 (Proposed Biosimilar to Adalimumab)	Humira (Adalimumab), Switch to SB5	Humira (Adalimumab), Continue as Humira
Number of subjects analysed	212	106	111
Units: number	163	86	79

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

at Week 24

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

17.0

Reporting group title

SB5 (Proposed Biosimilar to Adalimumab)

Reporting group description

SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)

Reporting group title

Humira (Adalimumab)

Reporting group description

Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.

Serious adverse events	SB5 (Proposed Biosimilar to Adalimumab)	Humira (Adalimumab)
Total subjects affected by serious adverse events
subjects affected / exposed	9 / 268 (3.36%)	16 / 273 (5.86%)
number of deaths (all causes)	0	2
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
subjects affected / exposed	1 / 268 (0.37%)	0 / 273 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glioblastoma multiforme
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lymphoma
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metastases to spine
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Papillary thyroid cancer
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Seminoma
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Craniocerebral injury
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ulna fracture
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular pseudoaneurysm
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	1 / 268 (0.37%)	0 / 273 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Nervous system disorders
Lumber radiculopathy
subjects affected / exposed	1 / 268 (0.37%)	0 / 273 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple sclerosis
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Eosinophilia
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Retinal oedema
subjects affected / exposed	1 / 268 (0.37%)	0 / 273 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Femoral hernia, obstructive
subjects affected / exposed	1 / 268 (0.37%)	0 / 273 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 268 (0.37%)	0 / 273 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nasal inflammation
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
subjects affected / exposed	1 / 268 (0.37%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Escherichia urinary tract infection
subjects affected / exposed	1 / 268 (0.37%)	0 / 273 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 268 (0.37%)	0 / 273 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchopneumonia
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 268 (0.00%)	2 / 273 (0.73%)
occurrences causally related to treatment / all	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 268 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	SB5 (Proposed Biosimilar to Adalimumab)	Humira (Adalimumab)
Total subjects affected by non serious adverse events
subjects affected / exposed	35 / 268 (13.06%)	44 / 273 (16.12%)
Nervous system disorders
Headache
subjects affected / exposed	11 / 268 (4.10%)	14 / 273 (5.13%)
occurrences all number	13	15
Infections and infestations
Nasopharyngitis
subjects affected / exposed	24 / 268 (8.96%)	30 / 273 (10.99%)
occurrences all number	27	34

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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