Crohn's disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Conditions
Interventions
Product Name: Certolizumab pegol
Product Code: CDP870
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Certolizumab pegol (rINN)
CAS Number: 428863-50-7
Current Sponsor code
Sponsors
UCB PHARMA S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men and women older than 18 years 2. Diagnosis of Crohn’s disease confirmed 3. Eligible to anti-TNF therapy 4. HBI=7 5. Are able to understand the information provided to them and to give their written informed consent, which must be obtained prior to any study procedures 6. Are registered to a health security system 7. Female patient either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptives; intra-uterine device; barrier and spermicide) abstinence is not an acceptable method). 8. have screening laboratory results as follows : - ALT and AST levels not exceeding 2 times the upper limit of normal for the local lab - serum creatinine or = to 100 000 cells/µL - neutrophils > or = to 1 500 cells/µL 9. Have met all the concomitant medication criteria (5-ASA, antibiotics, corticosteroids, immunosuppressants) 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
Exclusion criteria: Subjects with 1. abscess or suspicion of abscess 2. symptomatic known obstructive strictures or bowel perforation in last 6 months 3. short bowel syndrome 4. surgical bowel resection within the past 6 months or is planned resection at any time while enrolled in the study 5. current diagnosis of ulcerative colitis or indeterminant colitis as determined by investigator or Sponsor 6. ostomy or ileoanal pouch 7. currently receiving total parenteral nutrition 8. positive stool cultures for enteric pathogens during screening (e.g. C. difficile) 9. Previous participation in a certolizumab pegol study 10. treatment with any investigational agent within 5 half-lives prior to study drug administration 11. treatment with infliximab within 8 weeks prior to the Baseline visit 12. treatment with any other biologic product within 12 weeks prior to screening 13. any prior exposure to natalizumab (Tysabri) 14. history of drug or alcohol abuse 15. Females who are pregnant or breast feeding 16. Females of child bearing age not practicing effective birth control 17. History of malignancy within last 5 years (except carcinoma –in situ of cervix or basal cell carcinoma that was successfully treated) 18. History of lymphoproliferative disease 19. History of human immunodeficiency disease (HIV), chronic or active hepatitis B or hepatitis C 20. History of Congestive Heart Failure (CHF), including medically controlled asymptomatic CHF 21. Has had a opportunistic infection within 6 months prior to screening 22. Has had a serious infection, has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 3 months prior to screening. 23. Has a transplanted organ (except corneal transplant) 24. Has had a chest x-ray within 8 weeks prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or active infection, 25. History of a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening 26. any live virus or bacterial vaccination received within 3 months of first study drug administration, or planned during the trial or 3 months after last dose of study drug 27. TB or positive PPD skin test or positive chest X-ray or patients in close contact with an individual with active TB 28. History of known demyelinating disease 29. Has signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric or cerebral disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the clinical efficacy of certolizumab pegol 400mg in patients suffering from Crohn's disease administered subcutaneously at Weeks 0, 2 and 4 in two different settings (either at hospital or at-home) evaluated by clinical response at week 6;Primary end point(s): Clinical response rate at week 6 defined as HBI decrease from baseline = 3 points. ;Secondary Objective: To assess : • the clinical efficacy of certolizumab pegol in patients suffering from Crohn's disease administered in two different settings (either at hospital or at-home) evaluated by clinical response at week 14. • the impact of the self-administration in each setting (either at the hospital or at home) on the clinical efficacy in patients suffereing from Crohn's disease evaluated by the clinical response at Week 14 • the clinical efficacy of certolizumab pegol in patients suffering from Crohn's disease administered in two different settings (either at hospital or at-home) evaluated by clinical remission at week 6 and 14. • the overall clinical safety and tolerability of certolizumab pegol in patients suffering from Crohn's disease administered in two different settings (either at hospital or at-home) • the impact of the self administration on the safety in patients suffering from Crohn's disease in each setting (either at the hospital or at home) | — |
Countries
France
Outcome results
None listed