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)

Phase 3

Completed

Conditions: Ankylosing Spondyloarthritis
Bechterew's Disease
10023213

Registration Number: NL-OMON36612

Lead Sponsor: CB BIOSCIENCES GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

To be eligible to participate in this study, all of the following criteria must be met:
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 (eg, able to understand and complete diaries), 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*
duration as defined by the ASAS criteria with sacroiliitis documented by x-ray or MRI.
6. Subjects must have active disease as defined by
- BASDAI score * 4
- Back pain * 4 on a 0 to 10 NRS (from BASDAI item 2)
7. Subjects must have been intolerant to or had an inadequate response to at least 1 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.

Exclusion Criteria

1. The subject has previously participated in this study or has previously received CZP
treatment in or outside of another clinical study.
2. The subject 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. Subject has history of chronic alcohol abuse (more than 14 drinks/units per week for
women and 21 drinks/units for men [1 drink=4oz of wine, 12oz of beer, or 1oz of hard
liquor] or 330mL of 5% alcohol by volume beer=2 units, 125mL of 12% wine=1.5 units,
50mL of 40% spirits=2 units) or drug abuse within the last year.
4. Subject has any medical or psychiatric condition (according to the Diagnostic and
Statistical Manual of Mental Disorders [DSM] criteria) that, in the opinion of the
Investigator, can jeopardize or would compromise the subject*s ability to participate in
this study.
5. Subject has a known hypersensitivity to any components of CZP, placebo or with a
history of an adverse reaction to polyethylene glycol (PEG).
6. Subjects must not have a diagnosis of any other inflammatory arthritis (eg, RA, systemic
lupus erythematosus, sarcoidosis).
7. Subjects must not have total spinal ankylosis (*bamboo spine*) or a secondary,
noninflammatory condition (eg, osteoarthritis or fibromyalgia).
8. Subjects must not have used the following medications in the manner as detailed by the
exclusion criteria in the table in the protocol amendment 1 on page 36.
9. Known TB disease, high risk of acquiring TB infection, or latent TB infection;For the rest of the exclusion criteria, please refer to Protocol Amendment 1 23 Nov 2009 page 34.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to demonstrate the efficacy of CZP<br /><br>administered sc at<br /><br>the doses of CZP 200mg Q2W and CZP400mg Q4W after a loading dose of CZP 400mg at<br /><br>Weeks 0, 2, and 4 on the signs and symptoms of active axial SpA.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives of the study are to assess the effects on safety and<br /><br>tolerability and<br /><br>to demonstrate the effects of CZP on:<br /><br>- Health outcomes<br /><br>- Partial remission<br /><br>- Spinal mobility<br /><br>- Structural damage and inflammation in the subpopulation of subjects with MRI</p><br>