Clinical Trials Register

Summary
EudraCT Number:	2009-017998-37
Sponsor's Protocol Code Number:	AGO/2009/015
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-04-11
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2009-017998-37

A.3

Full title of the trial

Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFα-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.

Scintigrafische detectie van tumor necrosis factor aan de hand van een radiogelabeld TNFα-blokker bij patiënten met actieve reumatoïde arthritis en actieve axiale en perifere spondyloarthropatie.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFα-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.

Scintigrafische detectie van tumor necrosis factor aan de hand van een radiogelabeld TNFα-blokker bij patiënten met actieve reumatoïde arthritis en actieve axiale en perifere spondyloarthropatie.

A.4.1

Sponsor's protocol code number

AGO/2009/015

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Ghent University Hospital
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ghent University Hospital
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	UCB Pharma NV
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Ghent University Hospital
B.5.2	Functional name of contact point	Bimetra Clinics
B.5.3	Address:
B.5.3.1	Street Address	De Pintelaan 185
B.5.3.2	Town/ city	Ghent
B.5.3.3	Post code	9000
B.5.3.4	Country	Belgium
B.5.4	Telephone number	3293320500
B.5.5	Fax number	3293320520
B.5.6	E-mail	Bimetra.Clinics@uzgent.be

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Cimzia 200 mg solution for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	UCB Pharma SA
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Certolizumab pegol
D.3.4	Pharmaceutical form	Solution for injection/infusion in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CERTOLIZUMAB PEGOL
D.3.9.1	CAS number	428863-50-7
D.3.9.4	EV Substance Code	SUB25423
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	99mTc-S-HYNIC Certolizumab pegol
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CERTOLIZUMAB PEGOL
D.3.9.1	CAS number	428863-50-7
D.3.9.4	EV Substance Code	SUB25423
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	Yes
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis.
Patients with an active Crohn's disease.

E.1.1.1

Medical condition in easily understood language

Patients with an active rheumatoid arthritis and patients with an active axial and peripheral spondyloarthropathy.
Patients with erosive hand arthrosis.
Patients with an active Crohn's disease.

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	PT
E.1.2	Classification code	10011401
E.1.2	Term	Crohn's disease
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	HLT
E.1.2	Classification code	10052775
E.1.2	Term	Spondyloarthropathies
E.1.2	System Organ Class	100000004859

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	HLT
E.1.2	Classification code	10039078
E.1.2	Term	Rheumatoid arthropathies
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To test the safety and efficacy of Cimzia, when administered to patients with active rheumatoid arthritis, spondyloarthropathy or Crohn's disease.

De veiligheid en efficiëntie van Cimzia nagaan bij patiënten met een actieve reumatoïde arthritis,n spondyloarthropathie of de ziekte van Crohn.

E.2.2

Secondary objectives of the trial

- To map the biodistribution of TNF-α by administering a radioactive labeled TNFα-blokker (Cimzia, labeled with 99 Technetium) in patients with active rheumatoid arthritis and spondyloarthropathy, and Crohn's disease and erosive hand OA;
- To show the correlation between observed sacroilliitis on MRI (golden standard) versus tracer captation in sacroilliacal joints, visualised with SPECT recordings after administration of the labeled Cimzia;
- To evaluate whether the used scintigraphy technique (radioactive labeled Certolizumab pegol as tracer) is a predictor for clinical remission, when treated with Cimzia in patients with active rheumatoid arthritis and spondyloarthritis and Crohn's disease.

- De biodistributie van TNFα in kaart brengen aan de hand van het toedienen van een radiogelabeld TNFα-blokker (Cimzia, gelabeld met 99 Technetium) bij patiënten met actieve reumatoïde arthritis en spondyloarthropathie, of de ziekte van Crohn.
- Het aantonen van een goede correlatie tussen de waargenomen sacroilliitis op MRI (de gouden standaard) versus de tracercaptatie thv de sacroilliacale gewrichten gevisualiseerd met SPECT opnames na toediening met het radiogelabeld Cimzia.
- Het aantonen of deze scintigrafietechniek (radiogelabeld Certolizumab pegol als tracer) een predictor is voor het bereiken van klinische remissie met een behandeling met Cimzia bij patiënten met actieve reumatoïde arthritis en spondyloarthritis en de ziekte van Crohn.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- age between 18 and 70 years old
- diagnosed with rheumatoid arthrosis according to the ACR-criteria,
OR
diagnosed with axial spondyloarthropathy according to the ASAS criteria (of which 5 of them should meet the modified New York criteria),
OR
diagnosed with peripheral spondylarthropathy
- no active tuberculosis
- no pregnant women or women who are not using contraceptives when applicable
- patients need to understand the study and give informed consent

OR diagnosed with erosive hand OA
OR diagnosed with active Crohn's disease

- leeftijd tussen 18 en 70 jaar
- diagnose van reumatoïde arthritis gedefinieerd volgens de
ACR- criteria,
OF
diagnose van axiale spondylarthropathie volgens de huidige ASAS criteria (waarvan 5 patiënten tevens voldoen aan de modified New York criteria)
OF
diagnose van perifere spondyloarthropathie
- anti-TNF therapie naïef
- geen actieve tuberculose
- vrouwelijke patiënten dienen ofwel post-menopausaal te zijn voor tenminste een jaar, ofwel onmogelijkheid om zwanger te worden door chirurgie ofwel op een efficiënte en aanvaardbare methode van contraceptie te gebruiken
- patiënten dienen in staat te zijn om de informatie te begrijpen en dienen een informed consent te tekenen alvorens de participatie

OF gediagnosticeerd met erosieve hand OA
OF gediagnosticeerd met actieve ziekte van Crohn.

E.4

Principal exclusion criteria

- no experimental (non-) biological therapy in the last 3 months, or within 5 halflives befor baseline visit
- no anti-TNF therapy
- no rituximab and/or abatacept
- known hypersensitivity vs certolizumab pegol or one of his components
- medical history of serious progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebreal diseases
- serious or life-threatening infections over the last 6 months, or signs of current or recent infection
- active or latent tuberculosis
- known previous or current viral hepatitis B or C
- known HIV infection
- presence of malignity or history of maligne pathology
- History or signs of lyph-proliferative condition
- mild to serious cardiac failure

- geen experimentele biologisch en niet-biologische therapie gehad hebben de laatste drie maanden of binnen de 5 half-lives vooraleer de baseline visite
- geen anti-TNF therapie gekregen hebben
- geen behandeling met rituximab en/of abatacept gekregen hebben
- gekende hypersensitiviteit tegenover certolizumab pegol of één van zijn bestanddelen
- huidige of recente voorgeschiedenis van ernstige progressieve ongecontroleerde renale, hepatische, hematologische, gastrointestinale, endocriene, pulmonaire, cardiale, neurologische of cerebrale ziekten
- ernstige of levensbedreigende infecties de laatste 6 maanden;tekenen van huidige of recente infectie
- actieve of latente tuberculose
- gekende eerdere of huidige virale hepatitis B of hepatitis C
- gekende HIV infectie
- aanwezigheid van maligniteit of voorgeschiedenis van maligne pathologie
- voorgeschiedenis van een lymfeproliferatieve aandoening
- matig tot ernstig hartfalen

E.5 End points

E.5.1

Primary end point(s)

Patients who are in clinical remission for 2 consecutive major visits, will be discontinued from the study medication.

E.5.1.1

Timepoint(s) of evaluation of this end point

After 12 weeks, 24 weeks, 36 weeks and 48 weeks of administration of Cimzia.

E.5.2

Secondary end point(s)

Percentage of patients who are going into remission and the duration of remission

E.5.2.1

Timepoint(s) of evaluation of this end point

After 12 weeks, 24 weeks, 36 weeks and 48 weeks of administration of Cimzia.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last visit last subject

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

No different

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-06-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2019-03-26

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