A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CERTOLIZUMAB PEGOL IN COMBINATION WITH METHOTREXATE FOR INDUCING AND SUSTAINING CLINICAL RESPONSE IN THE TREATMENT OF DMARD-NAÏVE ADULTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS

Phase 3

Completed

Conditions: Early phase Rheumatoide Artritis
Rheumtoide Arteritis
10027665

Registration Number: NL-OMON37680

Lead Sponsor: CB Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

1. An IRB/ IEC approved written Informed Consent form is signed and dated by the subject prior
to any study procedure.
2. To allow collection of blood samples for the genomic, genetic and proteomic analysis the
subjects must have signed and dated an IRB/ IEC approved written Pharmacogenomics
Informed Consent form.
3. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand
and complete diaries), visit schedule, or medication intake according to the judgment of the
Investigator.
4. Subject is male or female and must be at least 18 years old at the Screening Visit.
5. 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 method and
spermicide) at Screening. 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.
6. Subjects must have a time since diagnosis of adult-onset RA less than 1 year as defined by the
2010 ACR / EULAR classification criteria from Screening Visit.
7. Subjects must be DMARD-naïve at Screening and Baseline (except antimalarials, see Section
6.2.2).
8. Subjects must have a positive RF or positive ACPA result at Screening.
9. Subjects must have active RA disease as defined by:
* * 4 swollen joints and * 4 tender joints (DAS28 joint) at Screening and Baseline.
* DAS28(ESR) >3.2 at Screening and Baseline.
* CRP *10 mg/L at Screening and/or ESR *28 mm/hour at Screening and Baseline.

Exclusion Criteria

1. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the
study or within 10 weeks following last dose of study drug.
2. The subject has previously participated in this study and has received CZP treatment, or
has previously received CZP in or outside of another clinical study.
3. 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.
4. The subject has a known hypersensitivity to any components of CZP or with a history of
an adverse reaction to polyethylene glycol (PEG).
5. Subjects must not have a secondary, noninflammatory type of musculoskeletal condition
(eg, osteoarthritis or fibromyalgia) 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 RA.
6. Subjects must not have a diagnosis of any other inflammatory arthritis (eg, psoriatic
arthritis or ankylosing spondylitis) nor have a Steinbrocker IV functional capacity.
7. Subjects must not have received any experimental nonbiological therapy in the 3 past
months or within 5 half-lives prior to Baseline (whichever is longer).
8. Subjects must not have received any experimental or approved biological agent (e.g. anti-
TNF therapy, anti-IL1, or IL6, etc) prior to Baseline.
9. Subjects must not have used the following medications in the manner as detailed by the
exclusion criteria column in the table 6.1 in the study protocol.
10. 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).
11. Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and
symptoms suggestive of lymphoproliferative disease.
12. Subjects with a history of blood dyscrasias.
13. Subjects with a current or recent history, as determined by the Investigator, of severe,
progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine,
pulmonary, cardiac, neurological, or cerebral disease or other significant
immunological/inflammatory disease including systemic lupus erythematosus,
inflammatory bowel disease.
14. Subjects with congestive heart failure as defined by the New York Heart Association 1994
classification criteria.
15. Subjects with a history of, or suspected, demyelinating disease of the central nervous
system (eg multiple sclerosis or optic neuritis).
16. Subjects with any other condition (ie, clinically significant laboratory values) which in the
Investigator*s judgment would make the subject unsuitable for inclusion in the study.
17. Subject with a value >1.5x ULN for any of the following liver function tests (LFTs) at
Screening:
* Aspartate aminotransferase (AST) (glutamic oxaloacetic transaminase [GOT])
* Alanine aminotransferase (ALT) (glutamate*pyruvate transaminase [GPT])
18. Subject has history of chronic alcohol or drug abuse within the last 1 year.
19. Subject has any medical or psychiatric condition that, in the opinion of the Investigator,
can jeopardize or would compromise the subject*s ability

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Period1 ; primary efficacy variable is the proportion of subjects in sustained<br /><br>remission (defined as DAS28[ESR] <2.6 at Week 40 and Week 52 visits) at Week 52<br /><br><br /><br>Period 2 ; primary efficacy variable is the proportion of subjects who maintain<br /><br>LDA (DAS28[ESR] *3.2) from Week 52 through Week 104 without flaring.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Period 1 ; key secondary efficacy variable is: The proportion of subjects in<br /><br>sustained LDA (defined as DAS28[ESR] *3.2 at Week 40 and Week 52 visits) at<br /><br>Week 52.<br /><br><br /><br>Radiographic, Clinical and Patient reported variables will be assessed from<br /><br>Baseline to Week 52 - for details see page 22-24 of the protocol<br /><br><br /><br>Periode 2 ; key secondary efficacy variable is the proportion of subjects who<br /><br>are in sustained remission at Week 52 and maintain their remission (DAS28[ESR]<br /><br><2.6) from Week 52 through Week 104 without flaring<br /><br><br /><br>Radiographicm, Clincial and Patient reported variables will be from Week 0 to<br /><br>Week 104/Withdrawal Visit and from Week<br /><br>52 to Week 104/Withdrawal Visit - for details see page 25-27 of the protocol</p><br>