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

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The EU Clinical Trials Register currently displays 44334 clinical trials with a EudraCT protocol, of which 7366 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 Double-blind Randomised, Parallel Phase I/IIb Study to Evaluate Initial Safety and Efficacy, Comparative Pharmacokinetics and Immunogenicity for CT-P6 and Herceptin in Metastatic Breast Cancer

Summary
EudraCT number	2009-014463-39
Trial protocol	LV BG GB
Global end of trial date	29 Dec 2023

Results information
Results version number	v1(current)
This version publication date	24 Aug 2024
First version publication date	24 Aug 2024
Other versions

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

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Trial information

Top of page

Sponsor protocol code

1.1

ISRCTN number

-

US NCT number

-

WHO universal trial number (UTN)

-

Sponsor organisation name

Celltrion, Inc.

Sponsor organisation address

23, Academy-ro, Yeonsu-gu, Incheon, Korea, Republic of, 22014, Incheon, Korea, Republic of,

Public contact

Celltrion, Inc., Celltrion, Inc., 82 850 5000, contact@celltrion.com, Celltrion, Inc., 82 8505000,

Scientific contact

Celltrion, Inc., Celltrion, Inc., 82 850 5000, contact@celltrion.com, Celltrion, Inc., 82 8505000,

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

18 Mar 2024

Is this the analysis of the primary completion data?

Yes

Primary completion date

25 Jun 2012

Global end of trial reached?

Yes

Global end of trial date

29 Dec 2023

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of this study is to demonstrate equivalent PK in terms of area under the curve at steady state (AUCSS) between CT-P6 and the comparator Herceptin in patients with metastatic breast cancer.

Protection of trial subjects

The study was conducted according to the protocol and in compliance with Good Clinical Practice (GCP) and other applicable regulatory requirements.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

02 Feb 2010

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

14 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Bulgaria: 10

Country: Number of subjects enrolled

Latvia: 15

Country: Number of subjects enrolled

Serbia: 11

Country: Number of subjects enrolled

Ukraine: 29

Country: Number of subjects enrolled

Korea, Republic of: 63

Country: Number of subjects enrolled

Russian Federation: 45

Country: Number of subjects enrolled

Taiwan: 1

Worldwide total number of subjects

174

EEA total number of subjects

25

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)

150

From 65 to 84 years

24

85 years and over

0

Subject disposition

Top of page

Recruitment details

Patients were enrolled at 7 sites across Bulgaria, Korea, Republic of, Latvia, Russian Federation, Serbia, Taiwan, and Ukraine.

Screening details

This study included females 18 years of age or older with HER-2 positive metastatic breast cancer who had not been treated in the first line metastatic setting.

Number of subjects started

174

Number of subjects completed

143

Reason: Number of subjects

excluded from Full Analysis Set (FAS): 31

Period 1 title

Main Study Treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer

Are arms mutually exclusive

Yes

CT-P6

Arm description

-

Arm type

Experimental

Investigational medicinal product name

Trastuzumab (CT-P6, Herzuma)

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for infusion

Routes of administration

Intravenous use

Dosage and administration details

8 mg/kg body weight on Day 1, Cycle 1, followed by 6 mg/kg body weight repeated at every 3 weeks until disease progression, death, or discontinuation.

Herceptin

Arm description

-

Arm type

Active comparator

Investigational medicinal product name

Trastuzumab (Herceptin)

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for infusion

Routes of administration

Intravenous use

Dosage and administration details

8 mg/kg body weight on Day 1, Cycle 1, followed by 6 mg/kg body weight repeated at every 3 weeks until disease progression, death, or discontinuation.

Number of subjects in period 1 ^[1]	CT-P6	Herceptin
Started	76	67
Completed	60	56
Not completed	16	11
Disease progression	11	7
Adverse Event	5	3
Other reason	-	1

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Overall, 31 enrolled patients who did not met definition of FAS was excluded.

Period 2 title

Treatment Period Beyond Cycle 8

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer

Are arms mutually exclusive

Yes

CT-P6

Arm description

-

Arm type

Experimental

Investigational medicinal product name

Trastuzumab (CT-P6, Herzuma)

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for infusion

Routes of administration

Intravenous use

Dosage and administration details

8 mg/kg body weight on Day 1, Cycle 1, followed by 6 mg/kg body weight repeated at every 3 weeks until disease progression, death, or discontinuation.

Herceptin

Arm description

-

Arm type

Active comparator

Investigational medicinal product name

Trastuzumab (Herceptin)

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for infusion

Routes of administration

Intravenous use

Dosage and administration details

8 mg/kg body weight on Day 1, Cycle 1, followed by 6 mg/kg body weight repeated at every 3 weeks until disease progression, death, or discontinuation.

Number of subjects in period 2	CT-P6	Herceptin
Started	60	56
Discontinued treatment after Cycle 8	60	56
Completed	0	0
Not completed	60	56
Consent withdrawn by subject	4	4
Physician decision	2	4
Disease progression	51	45
Adverse Event	1	-
Unknown	-	1
Other reason	2	2

Baseline characteristics

Top of page

Reporting group title

CT-P6

Reporting group description

-

Reporting group title

Herceptin

Reporting group description

-

Reporting group values	CT-P6	Herceptin	Total
Number of subjects	76	67	143
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	63	59	122
From 65-84 years	13	8	21
85 years and over	0	0	0
Age continuous
Units: years
median (full range (min-max))	56.0 (33 to 75)	56.0 (28 to 76)	-
Gender categorical
Units: Subjects
Female	76	67	143
Male	0	0	0

Subject analysis set title

Full Analysis Set (FAS)

Subject analysis set type

Full analysis

Subject analysis set description

All randomized patients who received any study drug and had at least one post-baseline assessment, with the exception of the patients who violated against Herceptin indication. Patients were analyzed according to the treatment to which they were randomized and not according to what they actually received, in the event there will be a discrepancy between the actual treatment received and the randomized treatment. All summaries of study population data, including disposition of patients, major protocol deviations, and analysis sets, as well as demographic and baseline characteristics were performed using the FAS. Also, all efficacy analysis were performed using the FAS.

Subject analysis set title

PK Analysis Set – Global (PKASg)

Subject analysis set type

Full analysis

Subject analysis set description

All FAS patients who had achieved steady state by the 8th cycle, which required 3 consecutive similar trough concentrations. Patients were analyzed according to the study drug they actually received. All summaries of PK parameter were performed using the PKASg.

Subject analysis sets values	Full Analysis Set (FAS)	PK Analysis Set – Global (PKASg)
Number of subjects	143	100
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	122	83
From 65-84 years	21	17
85 years and over	0	0
Age continuous
Units: years
median (full range (min-max))	56.0 (28 to 76)	56.0 (28 to 76)
Gender categorical
Units: Subjects
Female	143	100
Male	0	0

End points

Top of page

Reporting group title

CT-P6

Reporting group description

-

Reporting group title

Herceptin

Reporting group description

-

Reporting group title

CT-P6

Reporting group description

-

Reporting group title

Herceptin

Reporting group description

-

Subject analysis set title

Full Analysis Set (FAS)

Subject analysis set type

Full analysis

Subject analysis set description

All randomized patients who received any study drug and had at least one post-baseline assessment, with the exception of the patients who violated against Herceptin indication. Patients were analyzed according to the treatment to which they were randomized and not according to what they actually received, in the event there will be a discrepancy between the actual treatment received and the randomized treatment. All summaries of study population data, including disposition of patients, major protocol deviations, and analysis sets, as well as demographic and baseline characteristics were performed using the FAS. Also, all efficacy analysis were performed using the FAS.

Subject analysis set title

PK Analysis Set – Global (PKASg)

Subject analysis set type

Full analysis

Subject analysis set description

All FAS patients who had achieved steady state by the 8th cycle, which required 3 consecutive similar trough concentrations. Patients were analyzed according to the study drug they actually received. All summaries of PK parameter were performed using the PKASg.

Primary: AUCss at 6 months (8 treatment cycles).

Top of page

End point title

AUCss at 6 months (8 treatment cycles).

End point description

The primary endpoint was to demonstrate PK equivalence in terms of area under the concentration time curve at steady state (AUCss) between CT-P6 and the comparator. The primary endpoint was reached at 6 months (8 treatment cycle; Main Study Treatment Period).

End point type

Primary

End point timeframe

6 months

End point values	CT-P6	Herceptin
Number of subjects analysed	48	49
Units: ug*h/mL
arithmetic mean (standard deviation)	34400 ( 15000 )	31800 ( 9820 )

Geometric Mean Ratio

Comparison groups

Herceptin v CT-P6

Number of subjects included in analysis

97

Analysis specification

Pre-specified

Analysis type

equivalence

Method

Parameter type

Geometric Mean Ratio

Point estimate

104.57

Confidence interval

level

90%

sides

2-sided

lower limit

93.64

upper limit

116.78

Adverse events

Top of page

Timeframe for reporting adverse events

Up to approximately 14 years.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

13.0

Reporting group title

CT-P6

Reporting group description

-

Reporting group title

Herceptin

Reporting group description

-

Serious adverse events	CT-P6	Herceptin
Total subjects affected by serious adverse events
subjects affected / exposed	12 / 76 (15.79%)	19 / 67 (28.36%)
number of deaths (all causes)	2	3
number of deaths resulting from adverse events	0	1
Vascular disorders
Hypertension
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Biliary drainage
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Disease progression
subjects affected / exposed	1 / 76 (1.32%)	5 / 67 (7.46%)
occurrences causally related to treatment / all	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 1	0 / 2
Infusion related reaction
subjects affected / exposed	1 / 76 (1.32%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	1 / 76 (1.32%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleural effusion
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Endoscopic retrograde cholangiopancreatography
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	1 / 76 (1.32%)	0 / 67 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Spinal fracture
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Cardiac failure acute
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Nervous system disorders
Brain oedema
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	1 / 76 (1.32%)	0 / 67 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Blood and lymphatic system disorders
Febrile neutropenia
subjects affected / exposed	2 / 76 (2.63%)	3 / 67 (4.48%)
occurrences causally related to treatment / all	0 / 2	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 76 (0.00%)	3 / 67 (4.48%)
occurrences causally related to treatment / all	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Colitis
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	1 / 76 (1.32%)	0 / 67 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholangitis
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis cholestatic
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Acute tonsillitis
subjects affected / exposed	1 / 76 (1.32%)	0 / 67 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	2 / 76 (2.63%)	0 / 67 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gangrene
subjects affected / exposed	1 / 76 (1.32%)	0 / 67 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neutropenic infection
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 76 (1.32%)	0 / 67 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
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	1 / 76 (1.32%)	0 / 67 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypercalcaemia
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 76 (0.00%)	1 / 67 (1.49%)
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	CT-P6	Herceptin
Total subjects affected by non serious adverse events
subjects affected / exposed	75 / 76 (98.68%)	65 / 67 (97.01%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	7 / 76 (9.21%)	8 / 67 (11.94%)
occurrences all number	12	19
Aspartate aminotransferase increased
subjects affected / exposed	6 / 76 (7.89%)	7 / 67 (10.45%)
occurrences all number	8	16
Vascular disorders
Hypertension
subjects affected / exposed	5 / 76 (6.58%)	4 / 67 (5.97%)
occurrences all number	6	9
Nervous system disorders
Peripheral sensory neuropathy
subjects affected / exposed	21 / 76 (27.63%)	27 / 67 (40.30%)
occurrences all number	79	50
Neuropathy peripheral
subjects affected / exposed	23 / 76 (30.26%)	21 / 67 (31.34%)
occurrences all number	46	54
Headache
subjects affected / exposed	11 / 76 (14.47%)	13 / 67 (19.40%)
occurrences all number	16	18
Dizziness
subjects affected / exposed	6 / 76 (7.89%)	13 / 67 (19.40%)
occurrences all number	11	23
Blood and lymphatic system disorders
Neutropenia
subjects affected / exposed	32 / 76 (42.11%)	33 / 67 (49.25%)
occurrences all number	59	85
Leukopenia
subjects affected / exposed	8 / 76 (10.53%)	12 / 67 (17.91%)
occurrences all number	10	28
Anaemia
subjects affected / exposed	9 / 76 (11.84%)	5 / 67 (7.46%)
occurrences all number	19	9
General disorders and administration site conditions
Asthenia
subjects affected / exposed	24 / 76 (31.58%)	10 / 67 (14.93%)
occurrences all number	52	14
Fatigue
subjects affected / exposed	10 / 76 (13.16%)	10 / 67 (14.93%)
occurrences all number	27	31
Pyrexia
subjects affected / exposed	10 / 76 (13.16%)	10 / 67 (14.93%)
occurrences all number	18	18
Oedema peripheral
subjects affected / exposed	8 / 76 (10.53%)	8 / 67 (11.94%)
occurrences all number	10	12
Chills
subjects affected / exposed	6 / 76 (7.89%)	7 / 67 (10.45%)
occurrences all number	11	8
Mucosal inflammation
subjects affected / exposed	4 / 76 (5.26%)	5 / 67 (7.46%)
occurrences all number	5	6
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	13 / 76 (17.11%)	18 / 67 (26.87%)
occurrences all number	23	38
Stomatitis
subjects affected / exposed	6 / 76 (7.89%)	11 / 67 (16.42%)
occurrences all number	13	14
Constipation
subjects affected / exposed	4 / 76 (5.26%)	10 / 67 (14.93%)
occurrences all number	6	14
Abdominal pain upper
subjects affected / exposed	4 / 76 (5.26%)	8 / 67 (11.94%)
occurrences all number	4	13
Dyspepsia
subjects affected / exposed	5 / 76 (6.58%)	3 / 67 (4.48%)
occurrences all number	6	3
Nausea
subjects affected / exposed	19 / 76 (25.00%)	17 / 67 (25.37%)
occurrences all number	51	41
Vomiting
subjects affected / exposed	5 / 76 (6.58%)	9 / 67 (13.43%)
occurrences all number	10	14
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	11 / 76 (14.47%)	8 / 67 (11.94%)
occurrences all number	13	11
Dyspnoea
subjects affected / exposed	8 / 76 (10.53%)	5 / 67 (7.46%)
occurrences all number	11	7
Oropharyngeal pain
subjects affected / exposed	3 / 76 (3.95%)	5 / 67 (7.46%)
occurrences all number	4	6
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	47 / 76 (61.84%)	44 / 67 (65.67%)
occurrences all number	59	50
Rash
subjects affected / exposed	10 / 76 (13.16%)	12 / 67 (17.91%)
occurrences all number	16	29
Pruritus
subjects affected / exposed	7 / 76 (9.21%)	12 / 67 (17.91%)
occurrences all number	11	18
Psychiatric disorders
Insomnia
subjects affected / exposed	7 / 76 (9.21%)	13 / 67 (19.40%)
occurrences all number	14	16
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	31 / 76 (40.79%)	31 / 67 (46.27%)
occurrences all number	134	127
Arthralgia
subjects affected / exposed	10 / 76 (13.16%)	15 / 67 (22.39%)
occurrences all number	33	29
Pain in extremity
subjects affected / exposed	10 / 76 (13.16%)	17 / 67 (25.37%)
occurrences all number	14	32
Bone pain
subjects affected / exposed	13 / 76 (17.11%)	6 / 67 (8.96%)
occurrences all number	22	10
Back pain
subjects affected / exposed	5 / 76 (6.58%)	11 / 67 (16.42%)
occurrences all number	7	19
Musculoskeletal pain
subjects affected / exposed	6 / 76 (7.89%)	7 / 67 (10.45%)
occurrences all number	7	9
Infections and infestations
Nasopharyngitis
subjects affected / exposed	7 / 76 (9.21%)	3 / 67 (4.48%)
occurrences all number	11	9
Upper respiratory tract infection
subjects affected / exposed	3 / 76 (3.95%)	6 / 67 (8.96%)
occurrences all number	3	10
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	7 / 76 (9.21%)	8 / 67 (11.94%)
occurrences all number	12	22

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

19 May 2010

Amendments in the eligibility crieria and procedures

02 Dec 2010

Amendments in the sample size calculation

23 Feb 2012

Clarification in determination of disease progression related to follow-up of patient was moved to the Investigator from ITRC

03 Jul 2013

Amendments in study duration and updated study protocol to open-label study

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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