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• Conditions: MedDRA version: 16.0Level: LLTClassification code 10002557Term: Ankylosing spondylitis and other inflammatory spondylopathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; axial spondyloarthritis (axial SpA); MedDRA version: 16.0Level: PTClassification code 10051265Term: SpondyloarthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2009-011719-19-BE
• Lead Sponsor: CB BioSciences GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-23
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

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. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified