A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

• Register: EUCTR
• Last refreshed on: 22 January 2018
• Main ID: EUCTR2007-004157-28-PT
• Date of registration: 12/12/2008
• Prospective Registration: Yes
• Primary sponsor: Abbott GmbH & Co. KG
• Public title: A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis
• Scientific title: A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis
• Date of first enrolment: 17/03/2009
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004157-28
• 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

Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Portugal, Slovakia, Spain, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject must have successfully enrolled in and completed either the M06-826
study or the M06-827 study.
2. Female must be either not of childbearing potential, defined as postmenopausal for at least 1 year prior to the previous study (M06-826 study or M06-827 study), or
surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy),
or is of childbearing potential and practicing an approved method of birth control
throughout the study and for 150 days after last dose of study drug. Examples of
approved methods of birth control include the following:
? Condoms, sponge, foam, jellies, diaphragm or intrauterine device
? Oral, parenteral or intravaginal contraceptives
? A vasectomized partner
3. Subject 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).
4. Subject must be able to self-inject study medication or have a designee or
healthcare professional who can inject the study medication.
5. Subject is judged to be in generally good health as determined by the principal
investigator based upon clinical evaluations performed during the preceding
adalimumab ulcerative colitis study (M06-826 study or the M06-827 study).

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:
A subject will be excluded from the study if he/she meets any of the following criteria:
1. For any reason, subject is considered by the investigator to be an unsuitable
candidate for participation in the M10-223 study.
2. Female who is pregnant will be excluded from this study.
3. Has not responded to weekly adalimumab therapy from Study M06-826 or
M06-827.
4. Female subject considering becoming pregnant during the study. There should be
at least a 150-day period between the last dose of study drug and conception.
5. History of malignancy other than a successfully treated non-metastatic cutaneous
squamous cell, basal cell carcinoma and/or localized carcinoma in situ of the
cervix. If the Week 52 (Study M06-826 or M06-827) colonoscopy/flexible
sigmoidoscopy shows evidence of dysplasia or a malignancy, subject must not be
enrolled in the study.
6. History of listeriosis, histoplasmosis, chronic or active hepatitis B infection,
human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
central nervous system (CNS) demyelinating disease, or untreated tuberculosis
(TB) (active and latent).
7. Currently receiving total parenteral nutrition (TPN).
8. Subject is not in compliance with prior and concomitant medication requirements
(Section 5.2.3).
9. Subjects with a poorly controlled medical condition, such as uncontrolled diabetes,
unstable ischemic heart disease, moderate or severe congestive heart failure, recent
cerebrovascular accidents and any other condition which, in the opinion of the
investigator or sponsor, would put the subject at risk by participation in this study.
10. Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior
to Baseline.
11. Subjects with known hypersensitivity to the excipients of adalimumab as stated in the label.
12. Current diagnosis of fulminant colitis and/or toxic megacolon.


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

Health Condition(s) or Problem(s) studied

Ulcerative Colitis
MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative

Intervention(s)

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
CAS Number: 331731-18-1
Other descriptive name: ABT-Humira
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective:

Main Objective: To evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with ulcerative colitis who participated in and successfully completed Study M06-826 (EudraCT number 2006-002781-20) or Study M06-827 (EudraCT number 2006-002782-40).

Primary end point(s): To evaluate long-term maintanence of response, safety and tolerability of repeated administration of adalimumab in subjects with ulcerative colitis.

Secondary ID(s)

2007-004157-28-BE

M10-223