Inclusion Criteria:
1. Participants >=18 years of age and in good health (Investigator discretion) with a
recent stable medical history
2. Diagnosis of UC for greater than 90 days prior to Baseline
3. Diagnosis of active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy
with biopsy during the Screening Period, with exclusion of infection
4. Active UC with a Mayo score of 6 to 12 points and endoscopy subscore of 2 to 3 points,
despite concurrent treatment with at least 1 of the following (oral corticosteroids or
immunosuppressants or both as defined below):
- Stable oral corticosteroid dose (prednisone >= 20 mg/day or equivalent) for at
least 14 days prior to Baseline or maintenance, corticosteroid dose (prednisone <
20 mg/day or equivalent) for at least 40 days prior to Baseline
and/or
- At least a 90 day course of azathioprine (AZA) or 6-mercaptopurine (6-MP) prior
to Baseline, with a dose of AZA >= 1.5 mg/kg/day or 6-MP >= 1 mg/kg/day (rounded
to the nearest available tablet formulation), or a dose that is the highest
tolerated by the participant (e.g., due to leukopenia, elevated liver enzymes,
nausea) during that time. Participant must be on a stable dose for at least 28
days prior to Baseline.
Concurrent therapy was not required for participants who were previously treated with
corticosteroids or immunosuppressants (AZA or 6-MP) during the past 5 years and in the
judgment of the Investigator have failed to respond to, or could not tolerate, their
treatment.
5. Participants may have been included if they had previously used an anti-tumor necrosis
factor (TNF) agent (except ADA) and discontinued its use due to a loss of response or
intolerance to the agent.
6. Had to be able to self-administer or had caregiver who could reliably administer
subcutaneous (SC) injections.
7. Had to be able and willing to give written informed consent and to comply with the
requirements of the study protocol.
8. Female had to be either not of childbearing potential, defined as postmenopausal for
at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy, or hysterectomy), or of childbearing potential and practicing an
approved method of birth control throughout the study and for 150 days after the last
dose of study drug. Examples of approved methods of birth control included the
following:
- Condoms, sponge, foams, jellies, diaphragm, or intrauterine device
- Oral, parenteral, intravaginal contraceptives for 90 days prior to study drug
administration
- A vasectomized partner The results of the serum pregnancy test performed at the
Screening Visit and urine pregnancy test performed at the Baseline Visit must
have been negative.
9. Judged to be in generally good health as determined by the Investigator
Exclusion Criteria:
1. History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch,
Koch pouch, or ileostomy for UC, or planned bowel surgery.
2. Received previous treatment with ADA or previous participation in an ADA clinical
study.
3. Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of
Baseline.
4. Received intravenous (IV) corticosteroids within 14 days of Screening or during the
Screening Period.
5. Received therapeutic enema or suppository, other than required for endoscopy, within
14 days of the Screening endoscopy and during the remainder of the Screening Period.
6. Current diagnosis of fulminant colitis and/or toxic megacolon.
7. Disease limited to the rectum (ulcerative proctitis).
8. Current diagnosis of indeterminate colitis.
9. Current diagnosis and/or history of Crohns disease (CD).
10. Currently receiving total parenteral nutrition.
11. Used aminosalicylates for < 90 days before Baseline or not on a stable dose for at
least 28 days before Baseline or discontinued use within 28 days of Baseline.
12. Positive Clostridium difficile stool assay.
13. Previously used infliximab or any anti-TNF agent within 56 days of Baseline.
14. Previously used infliximab or any anti-TNF agent without clinical response at any time
("primary non-responder") unless subject experienced a treatment-limiting reaction.
15. Infections requiring treatment with IV antibiotics, antivirals, or antifungals within
30 days of Baseline or oral antibiotics, antivirals, or antifungals within 14 days of
Baseline.
16. 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 showed evidence of
dysplasia or a malignancy, subject was not to be enrolled in the study.
17. History of listeria, histoplasmosis, chronic or active hepatitis B infection, human
immunodeficiency virus (HIV), immunodeficiency syndrome, central nervous system
demyelinating disease, or untreated tuberculosis (TB).
18. Female subject who was pregnant or breast-feeding or considering becoming pregnant
during the study (there should be at least 150 days between the last dose of study
drug and either conception or initiation of breast-feeding in women of childbearing
potential).
19. Poorly controlled medical condition(s), such as uncontrolled diabetes, unstable
ischemic heart disease, moderate to severe congestive heart failure (CHF), recent
cerebrovascular accident, and any other condition, which in the opinion of the
investigator, put the subject at risk by participation in the protocol.
20. Received any investigational agent within 30 days or 5 half lives prior to Baseline
(whichever was longer).
21. History of clinically significant drug or alcohol abuse during the past year.
22. Known hypersensitivity to the excipients of ADA as stated in the label.
23. Any prior exposure to Tysabri® (natalizumab), or Orencia® (abatacept) or any other
biological therapy [other than Kineret® (anakinra) and anti-TNF agents].
24. Currently taking both budesonide and prednisone (or equivalent) simultaneously.
