Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806

• Register: EUCTR
• Last refreshed on: 23 October 2017
• Main ID: EUCTR2007-006494-90-CZ
• Date of registration: 07/11/2008
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
• Scientific title: A Multi-center, Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Efficacy and the Long-term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Crohn's Disease Who Have Demonstrated a Clinical Response in the M06-806 Study
• Date of first enrolment: 11/02/2009
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006494-90
• 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: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Canada, Czech Republic, Poland, United Kingdom, United States

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Laboratories

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Laboratories

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject must have successfully enrolled in and completed Protocol M06-806
through Week 52.
2. Subject must be a responder at any time point during the M06-806 study.
3. If female, subjects who are sexually active and are of child-bearing potential
should be practicing an approved method of birth control throughout the study and for 150 days after study drug administration. Examples of approved methods of birth control include the following:
? Condoms, sponge, foam, jellies, diaphragm or intrauterine device (IUD)
? Oral, parenteral or intravaginal contraceptives
? A vasectomized partner
4. Subject of legal age, parent or legal guardian, as required, has voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form, after the nature of the study has been explained and the subject of legal age, subject's parent, or legal guardian, as required, has had the opportunity to ask questions. Subjects will be included in all discussions, and if required, their signature on an assent form will be obtained.
5. Parent or legal guardian of subject who is not of legal age, as required, 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. If a subject of legal age, must be willing to actively store, administer, and
accurately record study drug administration in the subject diary.
7. Subject is judged to be in acceptable medical condition, as determined by the
Principal Investigator based upon results of clinical and laboratory evaluations
done throughout the preceding Crohn's disease study M06-806.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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:
1. For any reason, the subject is considered by the Investigator to be an unsuitable candidate for continuing therapy in the M06-807 study.
2. Subject has abnormal laboratory or other test results that in the opinion of the Investigator will make the subject unsuitable to participate in this study.
3. 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.
4. History of listeriosis, histoplasmosis, chronic or active hepatitis B infection,
human immunodeficiency virus (HIV) infection, any immunodeficiency
syndrome, central nervous system (CNS) demyelinating disease or active TB
(receiving treatment or not receiving treatment). Ongoing severe infections such as sepsis and opportunistic infections will be exclusionary.
5. Subject with known, symptomatic obstructive strictures.
6. Subject who is planning surgical bowel resection at any time point while enrolled in the study.
7. Subject who has short bowel syndrome as determined by the Investigator.
8. Subject who is currently receiving total parenteral nutrition (TPN).
9. Subject who is unwilling to discontinue growth hormone prior to the first dose of open-label study drug at the Baseline visit of M06-807.
10. Female subject who is pregnant or currently breast-feeding.
11. Subject with a history of clinically significant drug or alcohol abuse in the last
year.
12. Subject with a poorly controlled medical condition such as: uncontrolled diabetes, recurrent infections, unstable ischemic heart disease, moderate to severe heart failure, recent cerebrovascular accidents or any other condition which, in the opinion of the Investigator or the Sponsor, will put the subject at risk by participation in the protocol.
13. Subject with any prior exposure to Tysabri (natalizumab).
14. Subject with a known hypersensitivity to the excipients of adalimumab as stated in the label.
15. Subject with a previous history of dysplasia of the gastrointestinal tract.
16. Subject is not in compliance with Section 5.2.3 of the study protocol, 'Prior and Concomitant Therapy'.


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

Health Condition(s) or Problem(s) studied

Crohn's disease
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: Humira 20 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: Humira 40mg/0.8ml solution for injection for paediatric use
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Main Objective: To evaluate the long-term maintenance of clinical response, safety and tolerability of repeated administration of adalimumab in pediatric subjects with Crohn's disease who participated in, and successfully completed, Protocol M06-806 through Week 52 and who meet all the inclusion and none of the exclusion criteria of Protocol M06-807.

Primary end point(s): Efficacy will be evaluated based on the proportion of subjects who maintain PCDAI clinical response at each visit. Clinical response is defined as PCDAI decrease = 15 points from the M06-806 Baseline score.

Other measures of disease activity being assessed in this study will be summarized, including CDAI scores, IMPACT III scores, WPAI-CD Caregiver, z-score for height velocity, bone x-ray, serological markers of bone metabolism, and healthcare resource utilization (unscheduled outpatient visits), adalimumab levels and anti-adalimumab levels (AAA).

Secondary Objective: Not Applicable.

Timepoint(s) of evaluation of this end point: Duration of study.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Duration of study.

Secondary end point(s): Safety.

Secondary ID(s)

NCT00686374

M06-807

2007-006494-90-BE

Source(s) of Monetary Support

AbbVie Inc.