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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00686374
• Date of registration: 27/05/2008
• Prospective Registration: No
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• 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: May 1, 2008
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00686374
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Andreas Lazar
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant must have successfully enrolled in and completed Study M06-806 through
Week 52.

- Participant must have been a responder at any time point during the M06-806 study
(defined as having achieved at least a 15-point reduction in the Pediatric Crohn's
Disease Activity Index (PCDAI) from Baseline).

- If female, participants who were sexually active and of child-bearing potential were
to 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
included the following:

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

2. Oral, parenteral or intravaginal contraceptives

3. A vasectomized partner

- Participant of legal age, parent or legal guardian, as required, voluntarily signed
and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
approved informed consent form, after the nature of the study was explained and the
participant of legal age, participant's parent, or legal guardian, as required, had
the opportunity to ask questions. Participants were to be included in all discussions,
and if required, their signature on an assent form was to be obtained.

- Parent or legal guardian of participant who was not of legal age, as required, must
have been willing to actively supervise storage and administration of study drug and
to ensure that the time of each dose was accurately recorded in the participant's
diary.

- Participants of legal age, must have been willing to actively store, administer, and
accurately record study drug administration in the participant diary.

- Participant was 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.

Exclusion Criteria:

- For any reason, the participant was considered by the Investigator to be an unsuitable
candidate for continuing therapy in the M06-807 study.

- Participant had abnormal laboratory or other test results that in the opinion of the
Investigator would make the participant unsuitable to participate in this study.

- 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.

- 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 were
exclusionary.

- Participant with known, symptomatic obstructive strictures.

- Participant who was planning surgical bowel resection at any time point while enrolled
in the study.

- Participant who had short bowel syndrome as determined by the Investigator.

- Participant who was receiving total parenteral nutrition (TPN).

- Participant who was unwilling to discontinue growth hormone prior to the first dose of
open-label study drug at the Baseline visit of M06-807.

- Female participant who was pregnant or currently breastfeeding.

- Participant with a history of clinically significant drug or alcohol abuse in the last
year.

- Participant 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, would put the participant at risk by participation
in the protocol.

- Participant with any prior exposure to Tysabri (natalizumab).

- Participant with a known hypersensitivity to the excipients of adalimumab as stated in
the label.

- Participant with a previous history of dysplasia of the gastrointestinal tract.



Age minimum: 7 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Adalimumab

Primary Outcome(s)

Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time [Time Frame: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408]

Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time [Time Frame: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408]

Secondary Outcome(s)

Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time [Time Frame: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408]

Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time [Time Frame: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384]

Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time [Time Frame: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384]

Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time [Time Frame: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384]

Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time [Time Frame: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384]

Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time [Time Frame: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408]

Secondary ID(s)

2007-006494-90

M06-807

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/04/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00686374