A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290

Phase 1

Conditions: lcerative Colitis
MedDRA version: 20.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000016670
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2015-001346-29-CZ

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 93

Inclusion Criteria

1.Subject must have successfully enrolled in and completed Protocol M11-290 through Week 52.
2.Subject of legal age, and/or 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, and/or Subject's parent, or legal guardian, as required, has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed. Subjects will be included in all discussions, and if required, their signature on an assent form will be obtained.
Diagnosis and Main Criteria for Inclusion/Exclusion (Continued):
Main Inclusion (Continued):
3.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 electronic diary.
If a subject is of a legal age, subjects must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections and to ensure that the time of each dose is accurately recorded in the subject's electronic diary.
4.If female, subject who is either not of childbearing potential, defined as pre-menstrual, or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of the study drug.
Examples of approved methods of birth control include the following (see local informed consent for more detail):
•Total abstinence from sexual intercourse;
•Condoms, sponge, foam, jellies, diaphragm or intrauterine device (IUD);
•Hormonal contraceptives for 90 days prior to study drug administration;
•A vasectomized partner.
5.Subject is judged to be in good medical condition, as determined by the Principal Investigator based upon results of clinical and laboratory evaluations done throughout the preceding ulcerative colitis Study M11-290.

Are the trial subjects under 18? yes
Number of subjects for this age range: 93
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for continuing therapy in the Study M10-870.
2.Female subjects who are pregnant or currently breastfeeding or considering becoming pregnant during the study.
3.Subject with Crohn's disease (CD) or indeterminate colitis (IC).
4.History of clinically significant drug or alcohol abuse in the last 12 months.
5.History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
6.History of chronic or active hepatitis B infection, human immunodeficiency virus (HIV) infection, any immunodeficiency syndrome, or active TB (regardless of receiving treatment).), or active viral infection that, based on the investigator’s clinical assessment, makes the subject an unsuitable candidate for the study.
7.History of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which would put the subject at risk by participation in the study.
8.History of malignancy (including lymphoma and leukemia) other than a successfully treated non metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
9.Subject who is planning surgical bowel resection at any time point while enrolled in the study.
10.Known hypersensitivity to adalimumab or its excipients.
11.Current diagnosis of fulminant colitis and /or toxic megacolon.

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 evaluate the long-term safety, tolerability, and maintenance of clinical response, of repeated administration of adalimumab in pediatric subjects with ulcerative colitis who participated in, and successfully completed, Protocol M11-290 through Week 52.;Secondary Objective: Not applicable;Primary end point(s): This study will utilize the PMS (and Mayo score if available) and PUCAI to determine efficacy of the study drug;Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96, 108, 120, 144, 168, 192, 216, 240, 264 and 288/Premature Discontinuation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Safety analyses will be performed on all subjects who receive at least one dose of study drug. ;Timepoint(s) of evaluation of this end point: Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276 and 288/Premature Discontinuation

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