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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-001913-41-CZ
• Date of registration: 07/04/2008
• Prospective Registration: Yes
• Primary sponsor: UCB Celltech
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 14/04/2008
• Target sample size: 550
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001913-41
• 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: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Belgium, Czech Republic, Estonia, Finland, Germany, Hungary, Italy, Latvia

Key inclusion & exclusion criteria

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 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
26. 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
27. History of known demyelinating disease such as optic n

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crohn`s disease
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease

Intervention(s)

Product Name: certolizumab pegol
Product Code: CDP870
Pharmaceutical Form: Powder for 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: range
Concentration number: 150-+/-15
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The proportion of subjects in clinical remission (clinical remission is defined as a total Crohn’s Disease Activity Index (CDAI) score of 150 or less) at week 6.

Main Objective: To assess the efficacy of certolizumab pegol versus placebo for induction of clinical remission in subjects with moderately to severely active Crohn’s disease.

Secondary Objective: To assess the effect of certolizumab pegol on induction of clinical response
To assess the impact of certolizumab pegol on the IBDQ
To assess the safety of certolizumab pegol therapy

Secondary ID(s)

2007-001913-41-FI

C87085