A phase IIIb, multinational, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of certolizumab pegol, a pegylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody, administered subcutaneously at weeks 0, 2 and 4 in subjects with moderately to severely active Crohn’s disease

Conditions: Crohn`s disease
MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease

Registration Number: EUCTR2007-001913-41-EE

Lead Sponsor: CB Celltech

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 550

Inclusion Criteria

1. Diagnosis of Crohn’s disease confirmed (at least 3 months prior to screening visit) by either radiological or endoscopic evidence.
2. Visualization of the GI tract by endoscopic or histological examination within the past 12 months.
3. Moderately to severely active Crohn’s disease (CDAI = 220 = 450) scored over the 7 days prior to the Baseline visit
4. No previous treatment with an anti-TNF agent
5. Male or female aged 18-75 years old
6. Are considered eligible according to the TB screening criteria.
7. Have screening laboratory results as follows:
Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) levels not exceeding 2 times the upper limit of normal for the central laboratory conducting the test.
Serum creatinine not exceeding 1.7 mg/dl ( SI: = 150 mmol/L)
Platelets = 100 x 103 cells/mL (SI: = 100 x 109 cells/L)
Neutrophils = 1.5 x 103cells/mL (SI: = 1.5 x 109 cells/L)
8. Have met all the concomitant medication criteria in the table provided in the protocol.
9.Subject must be intolerant to or have insufficient response from a standard therapy
10. Are capable of providing informed consent, which must be obtained prior to any study related procedures
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

1. Subject with Crohn’s disease who has perianal disease and/or any active draining fistulae within the 6 months immediately preceding the screening visit
2.Subjects with non-enterocutaneous fistulae. Subjects with healed perianal and entero-cutaneous fistulae as determined by the absence of drainage/seepage from fistula lumen following an application of clear pressure can be enrolled. In cases where determination is not possible the subject would be considered non-eligible.
3.Subjects with Crohn’s disease that solely involves the upper GI tract
4. Subject with abscess or suspicion of abscess
5. Subject with symptomatic known obstructive strictures or bowel perforation in last 6 months
6. Subject with short bowel syndrome
7. Subject who has had a surgical bowel resection within the past 6 months or is planning any resection at time while enrolled in the study or has had 2 or more resections in total
8. Subject with current diagnosis of Ulcerative Colitis (UC) or Indeterminant Colitis as determined by investigator or Sponsor
9. Subject with ostomy or ileoanal pouch
10. Subject who is currently receiving total parenteral nutrition
11. Subject with positive stool cultures for enteric pathogens during screening (e.g. C. difficile)
12. Previously treated in a certolizumab pegol study
13. Subject who has received any investigational agent within 5 half-lives prior to study drug administration
14. Subject who has received any biologic product within 12 weeks prior to screening
15. Subject with any prior exposure to natalizumab (Tysabri)
16. Subject with a history of drug or alcohol abuse
17. Females who are pregnant or breast feeding
18. Females of child bearing age or post puberty males not practicing effective birth control
19. Subjects with a history of malignancy irrespective of time (except carcinoma –in situ of cervix or basal cell carcinoma or squamous cell carcinoma that was successfully treated)
20. History or symptoms suggestive of lymphoproliferative disease as defined by unexplained lymphadenopathy and/or unexplained increase of white blood count of >20 x 109 cells/L
21. History of Human Immunodeficiency Virus (HIV), chronic or active Hepatitis B or Hepatitis C
22. History of Congestive Heart Failure (CHF), including medically controlled asymptomatic CHF
23. Has had a opportunistic infection (e.g. cytomegalovirus, pneumoncystis carii, aspergillosis, histoplasmosis, coccidioidomycosis) within 6 months prior to screening
24. Has had a serious infection, (e.g. pneumonia, sepsis, pyelonephritis), has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 3 months prior to screening. Less severe infections (acute upper respiratory tract infections, urinary tract infections) occurring in this timeframe need not be considered exclusionary at the discretion of the investigator and approval of the study physician. However subjects should not be enrolled when acutely ill with an intercurrent infection
25. Has a transplanted organ (except corneal transplant)
26. Has had a chest x-ray within 3 months prior to the first administration of study treatment that shows an abnormality suggestive of a malignancy or active infection, including TB
27. Has received or is expecting to receive, any live virus or bacterial vaccination within 3 months of first study drug administration, during the trial or 3 months after last dose of study drug
28. History of known demyelinating disease such as optic neuritis