A Multi-center, Double-blind Study to Evaluate the Safety, Efficacy and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Crohn's Disease - ND

• Conditions: Moderate to severe Crohn's disease; MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2006-004814-41-IT
• Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1.Subjects between the ages of 6 and 17, inclusive prior to baseline dosing.2.Subjects with a diagnosis of Crohn?s disease for greater than 12 weeks prior to screening confirmed by endoscopy or radiologic evaluation.3.Subjects with a PCDAI score of >30. 4.Parent or guardian has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject?s parent or legal guardian has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed or before any medication is discontinued for the purpose of this study. Pediatric subjects will be included in all discussions in order to obtain verbal or written assent.5.Parent or legal guardian must be willing to actively supervise storage and administration of study drug and to ensure that the time of each dose is accurately recorded in the subject?s diary.6.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.7.Subjects may have previously received infliximab providing the subject had an initial response and then discontinued use due to a loss of response or discontinued use due to intolerance.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a.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. b.History of listeria, histoplasmosis, chronic or active hepatitis B infection, human immunodeficiency virus (HIV), an immunodeficiency syndrome, central nervous system (CNS) demyelinating disease, or active TB (receiving treatment or not receiving treatment), severe infections such as sepsis and opportunistic infections. c.Subject with infectious colitis, ulcerative colitis or indeterminate colitis as determined by the investigator and Abbott Medical Monitor. d.Subject who has had surgical bowel resections within the past 24 weeks or is planning any resection at any time point while enrolled in the study.e.Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).f.Females who are pregnant or are currently breast-feeding.g.Subject with a history of clinically significant drug or alcohol abuse in the last year.h.Subjects with a poorly controlled medical condition such as: uncontrolled diabetes mellitus, moderate to severe 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.i.Subjects on azathioprine, 6-MP, or MTX who have not been on these medications for at least eight weeks prior to Baseline and on stable doses of these medications for at least four weeks prior to Baseline. Subjects who have been on azathioprine, 6-MP, or MTX who have discontinued these medications within 8 weeks of Baseline. j.Subjects on aminosalicylates, or Crohn's-related antibiotics (fluoroquinolones such as ciprofloxacin or nitroimidazole derivatives such as metronidazole) who have not been on stable doses of these medications for at least four weeks prior to Baseline. In addition, subjects on aminosalicylates or Crohn's-related antibiotic treatments who have discontinued these medications within four weeks of Baseline. k.Subjects on Growth Hormone who have not been on a stable dose for at least 12 weeks prior to Baseline. Subjects must consent to remain on a stable dose through the duration of the study. l.Subjects on prednisone > 40 mg/day (or equivalent) or subjects on < 10 mg/day prednisone or budesonide > 9 mg/day and subjects who were not on stable doses for at least 2 weeks prior to Baseline. In addition, subjects who discontinued either corticosteroid within 2 weeks of Baseline. Subjects taking both budesonide and prednisone (or equivalent) are excluded. m.Subject who has previously used infliximab within 8 weeks of Baseline. n.Previous treatment with adalimumab or previous participation in an adalimumab clinical study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to demonstrate the safety and efficacy of adalimumab and to assess the pharmacokinetics (PK) of adalimumab administered SC in pediatric subjects with moderate to severe CD.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint for this study is the proportion of subjects who are in clinical remission at Week 26, as measured by the PCDAI in the ITT population.