A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects with Crohn's Disease

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1. Subject must have successfully enrolled in and completed Study M14-115, including the Week 12 ileocolonoscopy.
2. If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) 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 study drug. Examples of approved methods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently are (see local informed consent for more detail):
• Implants, injectables, some intrauterine devices (IUDs), intrauterine hormone-releasing system (IUS)
• Sexual abstinence (when in line with preferred and usual lifestyle of the subject)
• A vasectomized partner
• Hormonal contraceptives for at least 90 days prior to study drug administration
Note: low-dose progestin-only oral contraceptives such as norethindrone 0.35 mg and lynestenol 0.5 mg are not considered adequate
Diagnosis and Main Criteria for Inclusion/Exclusion (Continued):
Main Inclusion (Continued):
3. Subject must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
4. Subject must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.

Exclusion Criteria

1. For any reason subject is considered by the investigator to be an unsuitable candidate.
2. Known hypersensitivity to adalimumab or its excipients.
3. Subject with an active systemic viral infection, or any active viral infection, that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study.
4. Positive pregnancy test at Baseline (Week 12 of Study M14-115).
5. Female subject who is considering becoming pregnant during the study.
6. 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 12 (Study M14 115) colonoscopy shows evidence of dysplasia or a malignancy, subject must not be enrolled in the study.
7. Subject 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.
8. Subject is not in compliance with prior and concomitant medication requirements throughout Study M14-115.
9. History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
10. History of invasive infection (e.g., listeriosis and histoplasmosis) or human immunodeficiency syndrome (HIV).
11. Subject who developed active Tuberculosis (TB) during Study M14-115, or subject who is non compliant with prophylaxis for latent TB initiated per Study M14-115 procedures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of subjects with endoscopic improvement, defined as an SES-CD <= 4<br /><br>and at least 2 point reduction versus baseline and no subscore greater than 1<br /><br>in any individual variable, at Week 40 among subjects with endoscopic<br /><br>improvement at Week 0 of Study M14-347.</p><br>

Secondary Outcome Measures

Name	Time	Method

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