M14-347

Principal Investigator: John  Valentine
Keywords: Crohns Department: Gastroenterology
IRB Number: 00076285 Co Investigator:  
Specialty: Gastroenterology
Sub Specialties: Inflammatory Bowel Disease/Crohn's/Ulcerative Colitis
Recruitment Status: Enrolling by invitation

Contact Information

Julie Will
julie.will@hsc.utah.edu
801-587-9060

Brief Summary

Objectives
The primary objective of this study is to evaluate the long-term efficacy, safety, and
tolerability of repeated administration of adalimumab in subjects with CD who
participated in and successfully completed Study M14-115.
The secondary objective is to assess PK and immunogenicity of adalimumab following
subcutaneous (SC) administration.
 
M14-115 is IRB Protocol#73136

Inclusion Criteria

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)
● 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
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.
 
Criteria Rationale
1 – 4 In order to select the appropriate subject population with a disease status representative of
the target population for evaluation.

Exclusion Criteria

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.
 
Criteria Rationale
1 – 7, 9 – 11 To reduce the risk to subjects or others and/or to exclude underlying conditions that
would compromise the subject's safety.
8 To avoid bias for the evaluation of efficacy and safety by concomitant use of other
medications or treatments.