A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.

• Register: EUCTR
• Last refreshed on: 15 July 2013
• Main ID: EUCTR2006-002078-23-GR
• Date of registration: 10/10/2006
• Prospective Registration: Yes
• Primary sponsor: Abbott GmbH & Co. KG
• Public title: A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.
• Scientific title: A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn's Disease.
• Date of first enrolment: 27/02/2007
• Target sample size: 1000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002078-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Diagnosis of moderate to severe Crohn's Disease for greater than 4 months (16 weeks) confirmed by endoscopy or radiologic evaluation.
2. Inadequate response to conventional therapy for Crohn's Disease in the opinion of and as documented by the treating physician.
3. Harvey Bradshaw Index score = 7.
4. Males and females = 18 and = 75 years of age at the Baseline visit.
5. 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, intrauterine device, subdermal implantation
· Oral or parenteral contraceptives (including hormonal vaginal devices and transdermal patches) for three months prior to study drug administration
· A vasectomized partner
6. If female, subject is not breast-feeding throughout the study and for 150 days after the last dose.
7. Subject or his/her legal representative has voluntarily signed and dated an informed consent approved by and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC).
8. Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that do not indicate an abnormal clinical condition which would place the subject at undue risk and thus preclude subject participation in the study.
9. Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication.

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), chronic or active Hepatitis B, an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease or active TB, currently or in the past.3. Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the Investigator and Abbott Medical Monitor.
4. Subject with symptomatic known obstructive strictures.
5. Subjects with abscess or suspicion of abscess, defined as a combination of at least 2 of the following features: fever, anal pain, or abdominal mass.
6. 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.
7. Subject with an ostomy or ileoanal pouch.
8. Subject who has short bowel syndrome as determined by the Investigator.
9. Subject who is currently receiving total parenteral nutrition (TPN) or any parenteral nutrition being delivered via a central vascular catheter.
10. Females who are pregnant or will not discontinue breast-feeding.
11. Subject who has received any investigational chemical agent in the past 30 days or 5 half-lives prior to Baseline (whichever is longer).
12. Subject who has received any investigational biological agent within 5 half-lives prior to Baseline.
13. Subject who has an active infection or has had systemic antibiotic, antiviral, or antifungal treatment within 3 weeks prior to Baseline for infection. Subjects are allowed to be on fluoroquinolones, nitroimidazoles or rifaximin for their non-infectious Crohn's symptoms.
14. Subject with a history of clinically significant drug or alcohol abuse in the last year.
15. Subjects with a poorly controlled medical condition such as: uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the Investigator or the sponsor, would put the subject at risk by participation in the protocol.
16. Subjects with positive C. difficile stool assay.
17. Subject who has previously used infliximab or any anti-TNF within 8 weeks of Baseline.
18. Previous treatment with adalimumab or previous participation in an adalimumab clinical study.
19. Screening laboratory and other analyses show any of the following abnormal results:
? Electrocardiogram (ECG) - with clinically significant abnormalities;
? Aspartate transaminase (AST) or alanine transaminase (ALT) >1.75 x the upper limit of the reference range;
? Total bilirubin = 3 mg/dL;
? Serum creatinine > 1.6 mg/dL;
20. Subjects on Imuran® (azathioprine), 6 MP, or MTX who have not been on stable doses of these medications for at least 4 weeks prior to Baseline. Additionally, for subjects on those medications, subjects must have been on azathioprine, 6 MP, or MTX for at least 12 weeks prior to Baseline. Moreover, subjects who have been on azathioprine, 6 MP, or MTX who have discontinued these medications within 12 weeks of Baseline are excluded.
21. Subjects on aminosalicylates, mesalamine, sulfasalazine, or Crohn's related antibiotics (fluoroquinolones, nitroimidazoles or rifaximin given for non-infectious Crohn's symptoms) who have not been on stable doses of these medications for at least 4 wee

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

Health Condition(s) or Problem(s) studied

Moderate to severe Crohn's Disease (Harvey Bradshaw Index score greater or equal to 7).
MedDRA version: 8.1 Level: LLT Classification code 10013099 Term: Disease Crohns

Intervention(s)

Trade Name: Humira
Pharmaceutical Form: Injection*

Product Name: Humira pre-filled PEN
Pharmaceutical Form: Injection*

Primary Outcome(s)

Secondary Objective:

Main Objective: To evaluate and delineate the safety and efficacy profile of adalimumab (Humira pre-filled syringe or Humira pre-filled PEN) when administered to subjects with moderate to severe Crohn's Disease.

Primary end point(s): Safety endpoints will include assessments of adverse events, laboratory data, physical exams and vital signs throughout the study.
Efficacy Endpoints are changes in Harvey-Bradshaw Index total score, SIBDQ, and WPAI assessed from Baseline to Weeks 2, 4, 8, 12 and 20. For efficacy evaluation, the Harvey-Bradshaw Index total score, assessment of draining fistulas, SIBDQ (except in Slovakia), WPAI, assessment of extra-intestinal manifestations and unscheduled outpatient visits, emergency room visits and hospitalization. Each variable will be assessed at Weeks 2, 4, 8, 12 and 20.

Secondary ID(s)

2006-002078-23-NL

M06-829