A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

* Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline
*Diagnosis of ulcerative colitis confirmed by colonoscopy with biopsy (< 6 months old), or colonoscopy with biopsy (>6 months old) followed by flexible sigmoidoscopy for confirmation during screening
*Active ulcerative colitis with Mayo Score of 6-12 points plus an endoscopic sub-score of 2-3 points, despite concurrent treatment with oral corticosteroids and or immunosuppressants
*Patient should be able to self administer or has a caregiver who can reliably administer subcutaneous injections
*Patient must be able and willing togive written informed consent and comply to study requirements of this study protocol
*Female who are of child bearing potential must use an acceptable method of birth control
*Negative pregnancy test in serum
*Judged to be in general good health by the investigator

Exclusion Criteria

1. History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis or is planning bowel surgery.
2. Received infliximab or any other anti-TNF agent in the past.
3. Received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
4. Received cyclosporine, tacrolimus, mycophenolate mofetil, or methotrexate within 60 days prior to Baseline.
5. Received intravenous corticosteroids within 14 days prior to Screening and during the Screening Period.
6. Received therapeutic enema or suppository, other than required for endoscopy, within 14 days prior to the Screening Visit and during the Screening Period.
7. Current diagnosis of fulminant colitis and/or toxic megacolon.
8. Subjects with disease limited to the rectum (ulcerative proctitis).
9. Current diagnosis of indeterminate colitis.
10. Current diagnosis and/or history of Crohn's disease.
11. Currently receiving total parenteral nutrition (TPN).
12. Discontinued use of azathioprine, or 6-MP within 28 days of Baseline.
13. Discontinued use of corticosteroid within 14 days of Baseline.
14. Subjects using aminosalicylates for less than 90 days prior to Baseline or not on a stable dose for at least 28 days prior to Baseline or discontinued use within 28 days of Baseline.
15. Subjects with positive Clostridium difficile (C. difficile) stool assay.
16. Persistent chronic or active non-UC related infections requiring treatment with intravenous (iv) antibiotics, iv antivirals, or iv antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline.
17. History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix. If the Screening colonoscopy/flexible sigmoidoscopy shows evidence of dysplasia or a malignancy, subject may not be enrolled in the study.
18. History of listeria, histoplasmosis, chronic or active Hepatitis B infection, human
immunodeficiency virus (HIV), immunodeficiency syndrome, central nervous system (CNS) demyelinating disease, or untreated tuberculosis (TB).
19. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study. There should be at least a 150-day period between the last dose of study drug and either conception or initiation of breast-feeding in women of childbearing potential.
20. Poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure, recent cerebrovascular accident and any other condition, which in the opinion of the investigator, would put the subject at risk by participation in the protocol.
21. Received any investigational agent within 30 days or 5 half lives prior to Baseline (whichever is longer).
22. History of clinically significant drug or alcohol abuse during the past year.
23. Subjects with known hypersensitivity to the excipients of adalimumab as stated in the label.
24. Subjects with any prior exposure to Tysabri® (natalizumab).
25. Subjects currently taking both budesonide and prednisone (or equivalent) simultaneously.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint of this study is the proportion of subjects with<br /><br>remission at Week 8.</p><br>

Secondary Outcome Measures

Name	Time	Method

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