Clinical Trials Register

Summary
EudraCT Number:	2009-011720-59
Sponsor's Protocol Code Number:	PsA001
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-06-04
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

Czechia - SUKL

A.2

EudraCT number

2009-011720-59

A.3

Full title of the trial

PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ADULT ONSET ACTIVE AND PROGRESSIVE PSORIATIC ARTHRITIS (PSA)

Multicentrická, randomizovaná, dvojitě zaslepená studie fáze 3 s paralelními skupinami, kontrolovaná placebem, jejímž cílem je vyhodnotit účinnost a bezpečnost přípravku Certolizumab pegol u subjektů s aktivní a progresivní psoriatickou artritidou (PSA) rozvinuvší se v dospělosti

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

PsA001

A.4.1

Sponsor's protocol code number

PsA001

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	UCB BioSciences GmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	UCB BioSciences GmbH
B.5.2	Functional name of contact point	CT Registries & Result Disclosure
B.5.3	Address:
B.5.3.1	Street Address	Alfred-Nobel Strasse 10
B.5.3.2	Town/ city	MONHEIM
B.5.3.3	Post code	40789
B.5.3.4	Country	Germany
B.5.4	Telephone number	+44217348 1515
B.5.5	Fax number	+44217348 1572
B.5.6	E-mail	clinicaltrials@ucb.com

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®
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 (CZP)
D.3.2	Product code	CDP870
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	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.3.9.2	Current sponsor code	CDP870
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	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	Yes
D.3.11.13.1	Other medicinal product type	PEGylated humanized antibody Fab' fragment

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Psoriatic arthritis

E.1.1.1

Medical condition in easily understood language

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.0
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	Psoriatic arthritis
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

The primary objectives of the study are to demonstrate the efficacy of CZP administered sc at the dose of 200mg every 2 weeks or 400mg every 4 weeks after loading with 400mg at Weeks 0, 2, and 4 on the signs and symptoms of active PsA and on the inhibition of progression of structural damage in adults with active PsA.

E.2.2

Secondary objectives of the trial

The secondary objectives of the study are to assess the effects on safety and tolerability and to demonstrate the effects of CZP on:
• Health outcomes
• Psoriatic skin disease in the subgroup of affected subjects (>3% BSA) at Baseline
• Dactylitis
• Enthesitis
• Axial involvement in subgroup of affected subjects (BASDAI ≥4) at Baseline

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subject must be at least 18 years old at the Screening Visit.
2. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent is signed and dated by the subject or designee/witness.
3. Subject is considered reliable, willing, and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the Investigator.
4. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral, parenteral, or implantable hormonal contraceptives, intrauterine device or barrier, or spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception during the study and for at least 10 weeks (or longer as per local requirement) after the last dose of study treatment. Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for at least 10 weeks (or longer as per local requirement) after the subject receives their last dose of study treatment.
5. Subject must have a diagnosis of adult onset PsA of at least 6 months’ duration as defined by the CASPAR criteria (see Appendix 17.1).
6. Subject must have active psoriatic skin lesions or a documented history of PSO.
7. Subject must have active arthritis as defined in the protocol.
8. Subjects must have failed 1 or more disease modifying antirheumatic drug (DMARDs).

E.4

Principal exclusion criteria

Subject:
1. has previously participated in this study or has previously received CZP treatment in or outside of another clinical study.
2. has participated in another study of a medication or a medical device under investigation within the last 3 months or is currently participating in another study of a medication or medical device under investigation.
3. has history of chronic alcohol abuse or drug abuse within the last year.
4. has any medical or psychiatric condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject’s ability to participate in this study.
5. has a known hypersensitivity to any components of CZP, placebo or with a history of an adverse reaction to polyethylene glycol (PEG).
6. must not have a diagnosis of any other inflammatory arthritis.
7. must not have a secondary, noninflammatory condition that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the subject’s primary diagnosis of PsA.
8. must not have used medications in the manner as detailed by the exclusion criteria in the protocol.
9. must not have received any nonbiological therapy for PsA not listed in section "Prior medications exclusion" of the protocol within or outside a clinical study in the 3 months or within 5 half lives prior to Baseline (whichever is longer).
10. must not have received experimental biological agents other than those listed in Table 6:1 and Table 6:2 of the protocol.
11. must not have received previous treatment with a PEGylated compound that resulted in a severe hypersensitivity reaction or an anaphylactic reaction.
12. may not have been exposed to more than 1 TNF antagonist prior to the Baseline Visit and may not be a primary failure to any TNF antagonist therapy (as defined in the protocol).
13. may not have been exposed to more than 2 previous biological response modifiers for PsA or PSO.
14. Female who are breastfeeding, pregnant, or plan to become pregnant during the study or within 3 months following the last dose of investigational product.
15. with a history of chronic or recurrent infections (more than 3 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster), hospitalization for any infection in the last 6 months, or any current sign or symptom that may indicate an infection.
16. with known TB disease, high risk of acquiring TB infection, or latent TB infection, as defined in the protocol.
17. with concurrent acute or chronic viral hepatitis B or C or with known human immunodeficiency virus infection (HIV).
18. with known history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, or Aspergillus.
19. with a history of an infected joint prosthesis at any time with that prosthesis still in situ.
20. receiving any live (includes attenuated) vaccination within the 8 weeks prior to Baseline.
21. with a high risk of infection in the Investigator’s opinion.
22. with a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
23. with concurrent malignancy or a history of malignancy (subjects with less than 3 excised basal cell carcinomas or with cervical carcinoma in situ successfully surgically treated more than 5 years prior to Screening may be included).
24. with class III or IV congestive heart failure as per the New York Heart Association 1964 criteria.
25. with a history of, or suspected, demyelinating disease of the central nervous system.
26. having had major surgery (including joint surgery) within the 8 weeks prior to Screening, or having planned surgery within 6 months after entering the study.
27. with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, or neurological disease.
28. with clinically significant laboratory abnormalities (as defined in the protocol).
29. with any other condition which, in the Investigator’s judgment, would make the subject unsuitable for inclusion in the study.

E.5 End points

E.5.1

Primary end point(s)

Primary efficacy variables:
(1) the ACR20 response at Week 12
(2) change from Baseline in mTSS at Week 24

Pharmacokinetic and pharmacodynamic variables:
- Certolizumab pegol plasma concentrations at periods defined in the protocol.
- Anti-certolizumab pegol antibodies at periods defined in the protocol.
- Biomarker and cytokine levels may be analyzed for exploratory research using selected samples collected for measurement of CZP plasma concentration as defined in the protocol.

Safety variables:
- adverse events
- serious adverse events,
- vital signs,
- physical examination
- signs and symptoms of latent or active tuberculosis
- measurements of laboratory parameters (hematology, biochemistry and urinalysis)
- pregnancy testing

E.5.1.1

Timepoint(s) of evaluation of this end point

(1) Week 12
(2) Week 24

E.5.2

Secondary end point(s)

Key secondary efficacy variables:
(1) ACR20 response at Week 24
(2) Change from Baseline in HAQ-DI at Week 24
(3) Change from Baseline in mTSS at Week 48
(4) PASI75 response at Week 24 in the subgroup of subjects with PSO involving at least 3% BSA at Baseline

E.5.2.1

Timepoint(s) of evaluation of this end point

(1) Week 24
(2) Week 24
(3) Week 48
(4) Week 24

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

from week 24 to 48: no placebo, dose-blind for subjects/investigators and from week 48: open-label

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

European Union

Argentina

Brazil

Canada

Mexico

United States

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

The end of the study is defined as the date of the last visit of the last subject in the study.

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.1.3

Elderly (>=65 years)

Yes

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

600

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)

Please refer to the following sections in the protocol
- 5.1 "Study description"
- 8.7 "Completion visit/Early withdrawal"
- 8.8 "Safety follow-up visit"

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

2010-08-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-03-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-08-24

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