Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00409682
• Date of registration: 08/12/2006
• Prospective Registration: Yes
• Primary sponsor: Abbott
• Public title: Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
• Scientific title: 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
• Date of first enrolment: April 2007
• Target sample size: 192
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00409682
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Czech Republic, France, Italy, Netherlands, Poland, United Kingdom, United States

Contacts

• Name: Roopal Thakkar
• Affiliation: Abbott

Key inclusion & exclusion criteria

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. PCDAI > 30 despite concurrent treatment with an oral corticosteroid, and/or
azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX) as defined below:

- Oral corticosteroid - Prednisone of = 10 mg/day or equivalent, but not exceeding
40 mg, with a stable dose for at least two weeks prior to Baseline.

- Azathioprine or 6-MP - AZA dose of = 1.5 mg/kg/day or 6-MP dose of = 1 mg/kg/day
rounded to the nearest available tablet formulation, or a dose that is the
highest tolerated for the subject, in the opinion of the investigator (for
example due to leukopenia, elevated liver enzymes, nausea, etc.) for at least 8
weeks prior to Baseline with a stable dose for at least 4 weeks prior to
Baseline.

- MTX dose of = 5 mg once weekly, either subcutaneously (SC), intramuscularly (IM),
or orally for subjects whose body weight is = 20 kg, or a dose that is the
highest tolerated for the subject, in the opinion of the investigator (for
example due to leukopenia, elevated liver enzymes, nausea, etc.) for at least 8
weeks prior to Baseline with a stable dose for at least 4 weeks prior to
Baseline.

- MTX dose of 0.2 mg/kg, up to 5 mg, once weekly, either SC, IM, or orally for
subjects whose body weight is < 20 kg, or a dose that is the highest tolerated
for the subject, in the opinion of the investigator (for example due to
leukopenia, elevated liver enzymes, nausea, etc.) for at least 8 weeks prior to
Baseline with a stable dose for at least 4 weeks prior to Baseline.

- Concurrent therapy will not be required for subjects who within the past 2 years
in the opinion of the Investigator have not responded to or could not tolerate
systemic corticosteroids, AZA, 6-MP, or MTX as defined below:

- Corticosteroids:

- Failed to successfully respond to corticosteroids, or

- Medical complications and/or adverse events (AEs) from corticosteroids
that in the judgment of their physician, precludes their use (e.g.
psychosis, uncontrolled diabetes, osteoporosis, or osteonecrosis).

- Azathioprine, 6-MP or MTX: -

- Failed to successfully respond to these drugs or

- Medical complications and/or AEs that in the judgment of their
physician, precludes their use (e.g. allergic reaction, pancreatitis,
elevated liver enzymes, hepatitis or leukopenia).

4. If female, subjects who were sexually active and were of child-bearing potential
practicing an approved method of birth control throughout the study and for 150 days
after study completion. Examples of approved methods of birth control included the
following:

- Condoms, sponge,foam,jellies,diaphragm, or intrauterine device (IUD)

- Oral,parenteral, or intravaginal contraceptives for 12 weeks prior to adalimumab
administration

- A vasectomized partner.

5. Parent or legal guardian,as required,had voluntarily signed and dated an informed
consent form (IFC), approved by an Institutional Review Board (IRB)/ Independent
Ethics Committee (IEC).

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. Parent or legal guardian was willing to actively supervise storage and administration
of study drug and to ensure that the time of each dose was accurately recorded in the
subject's diary.

8. Subjects who had 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.

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, histoplasmosis, chronic or active hepatitis B infection, human
immunodeficiency virus (HIV), an immunodeficiency syndrome, central nervous system
(CNS) demyelinating disease, or active tuberculosis (TB) (receiving treatment or not
receiving treatment), severe infections such as sepsis and opportunistic infections.

3. Subject with infectious colitis, ulcerative colitis or indeterminate colitis as
determined by the investigator and Abbott Medical Monitor.

4. Subject with symptomatic known obstructive strictures.

5. Subject who had surgical bowel resections within the past 24 weeks of the Baseline
visit or planned any resection at any time point while enrolled in the study.

6. Subject with an ostomy or ileo-anal pouch. (Subjects with a previous ileo-rectal
anastomosis were not excluded).

7. Subject who had short bowel syndrome as determined by the investigator.

8. Subject who was currently receiving total parenteral nutrition (TPN).

9. Females who were pregnant or were currently breast-feeding.

10. Subject who had received any investigational chemical agent in the past 30 days or 5
half-lives prior to Baseline (whichever was longer).

11. Subject who had received any investigational biological agent in the past 16 weeks or
5 half-lives prior to Baseline (whichever was longer).

12. Subject who has had systemic antibiotic, antiviral or antifungal treatment(s) within 3
weeks prior to Baseline for any non-Crohn's related infections.

13. Subject with a history of clinically significant drug or alcohol abuse in the last
year.

14. Subjects with a poorly controlled medical condition such as: uncontrolled diabetes,
recurrent infections, unstable ischemic heart disease, 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.

15. Subjects with positive C. difficile stool assay.

16. Subject who previously used infliximab within eight weeks of Baseline.

17. Subject who previously used infliximab and had not clinically responded


Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Adalimumab

Primary Outcome(s)

Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score = 10 at Week 26 [Time Frame: Week 26]

Secondary Outcome(s)

Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 52 [Time Frame: Week 52]

Percent of Participants With Clinical Remission as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score = 10 at Week 52 [Time Frame: Week 52]

Change From Baseline IMPACT III Scores at Week 52 (Observed Case) [Time Frame: Baseline and Week 52]

Percent of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score at Week 26 [Time Frame: Week 26]

Change From Baseline IMPACT III Scores at Week 26 (Observed Case) [Time Frame: Baseline and Week 26]

Secondary ID(s)

2006-004814-41

M06-806

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/08/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00409682