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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 30 June 2019
Main ID:  EUCTR2009-011719-19-GB
Date of registration: 15/03/2010
Prospective Registration: Yes
Primary sponsor: SCHWARZ BIOSCIENCES, GmbH, A Member of the UCB Group of Companies
Public title: PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)
Scientific title: PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXIAL SPA)
Date of first enrolment: 13/05/2010
Target sample size: 600
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011719-19
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: from week 24 to 48: no placebo, dose-blind for subjects/investigators and from week 48: open-label
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Czech Republic France Germany Hungary Italy Netherlands United Kingdom
Contacts
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Key inclusion & exclusion criteria
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.
3. The 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/implantable hormonal contraceptives, intrauterine device or barrier and 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 if required by local regulations) after the last dose of study treatment. Male subjects must agree to ensure they or their female partner(s) use adequate contraception during the study and for at least 10 weeks (or longer if required by local regulations) after the subject receives their last dose of study treatment.
5. Subjects must have a documented diagnosis of adult onset axial SpA of at least 3 months’ symptom duration as defined by the specified ASAS criteria. Fifty percent of the study population who meet the ASAS criteria should NOT fulfill the modified NY criteria for definite diagnosis of AS (as stated in the protocol).
6. Subjects must have active disease as defined in the protocol.
7. Subjects must have been intolerant to or had an inadequate response to at least 1 nonsteroidal anti inflammatory drug (NSAID). Inadequate response to an NSAID is defined as lack of response to at least 30 days of continuous NSAID therapy at the highest tolerated dose of the administered NSAID or the lack of response to treatment with at least 2 NSAIDs at the maximum tolerated dose for 2 weeks each.
Are the trial subjects under 18? no
Number of subjects for this age range:
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

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 total spinal ankylosis (“bamboo spine”), a diagnosis of any other inflammatory arthritis eg, RA, systemic lupus erythematosus, sarcoidosis, or a known diagnosis of fibromyalgia.
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 axial SpA.
8. must not have used the medications in the manner as detailed by the exclusion criteria in the protocol.
9. must not have received any nonbiological therapy for axial SpA 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 the Baseline Visit (whichever is longer).
10. must not have received any experimental biological agents other than those permitted in section "Prior medications exclusion" 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 agents for axial SpA.
14. Female who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product.
15. with a history of chronic or recurrent infections (more than 3 episodes requiring antibiotics or 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 (HIV) infection.
18. with known history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria, Blastomyces, or Aspergillus.
19. must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
20.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
axial spondyloarthritis (axial SpA)
MedDRA version: 14.0 Level: PT Classification code 10051265 Term: Spondyloarthropathy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Intervention(s)

Trade Name: Cimzia®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
Pharmaceutical Form: Solution for injection
INN or Proposed INN: certolizumab pegol
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Primary efficacy variable: ASAS20 response at Week 12.

Pharmacokinetic and pharmacodynamic variables:
- Certolizumab pegol plasma concentrations at periods defined in the protocol.
- Anti-CZP antibodies at periods defined in the protocol.
- Dickkopf-related protein 1 (DKK1) and sclerostin levels may be analyzed for exploratory biomarker research using selected samples collected for measurement of CZP plasma concentration

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

Secondary Objective: 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
• Partial remission
• Spinal mobility
• Structural damage and inflammation in the subpopulation of subjects with MRI
Main Objective: The primary objective of the study is to demonstrate the efficacy of CZP administered sc at the doses of CZP 200mg every 2 weeks and CZP400mg every 4 weeks after a loading dose of CZP 400mg at Weeks 0, 2, and 4 on the signs and symptoms of active axial SpA.
Secondary Outcome(s)
Secondary ID(s)
2009-011719-19-FR
AS001
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available: Yes
Date Posted: 02/09/2016
Date Completed: 18/08/2015
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-011719-19/results
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