A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab

• Register: EUCTR
• Last refreshed on: 15 July 2013
• Main ID: EUCTR2004-002934-20-BE
• Date of registration: 08/07/2005
• Prospective Registration: No
• Primary sponsor: Abbott GmbH & Co. KG
• Public title: A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab
• Scientific title: A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease who Have Lost Response or are Intolerant to Infliximab
• Date of first enrolment: 22/02/2005
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002934-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: Double blind: yes Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
1. A diagnosis of Crohn's disease confirmed by endoscopy or radiologic evaluation.
2. Crohn's Disease Activity Index (CDAI) score of ³220 and £450.
3. Males and females ³18 and £75 years of age at the screening visit.
4. If female, subject is either not of child bearing potential, defined as post menopausal for at least (1) year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control during the study and for 150 days after the last dose:
? Condoms, sponge, foam, jellies, diaphragm or intrauterine device
? Oral or parenteral contraceptives for three months prior to study drug administration
? A vasectomized partner
5. If female, subject is not breast-feeding throughout the study and for 150 days after the last dose.
6. Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
7. Adequate cardiac, renal and hepatic function as determined by principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits.
8. Subjects must have previously been administered infliximab and discontinued use due to a loss of response or intolerance to infliximab therapy. (See Appendix A for definitions).

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. History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma-in-situ of the cervix.
2. History of listeria, human immunodeficiency virus (HIV), an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or untreated TB.
3. Subject with ulcerative colitis.
4. Subject with symptomatic known obstructive strictures.
5. Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
6. Subject with an ostomy or ileoanal pouch.
7. Subject who has short bowel syndrome as determine by the investigator.
8. Subject who is currently receiving total parenteral nutrition (TPN).
9. Females who are pregnant or breast-feeding.
10. Subject who has received any investigational chemical agent in the past 30 days or 5 half-lives prior to Screening (whichever is longer).
11. Subject who has received any investigational biological agent in the past 3 months or 5 half-lives prior to Screening (whichever is longer).
12. Subject who has had systemic antibiotic, antiviral or antifungal treatment(s) within 3 weeks prior to Screening for all non-Crohn's related infections.
13. Subject with a history of clinically significant drug or alcohol abuse in the last year.



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

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Injection*
INN or Proposed INN: Adalimumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40/0.8-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective:

Primary end point(s): The primary efficacy variable will be the induction of clinical remission, which is defined as a CDAI score of <150 at week 4.

Main Objective: To demonstrate the efficacy of adalimumab in the treatment of subjects with Crohn's disease who either initially responded to administration of infliximab but stopped responding or were intolerant to infliximab; to delineate the safety of adalimumab when administered to subjects with Crohn's disease; to assess the pharmacokinetics (PK) of adalimumab following subcutaneous administration.

Secondary ID(s)

M04-691