Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).

Key facts

Study ID

NCT00408629

Run by

Abbott

People needed

518

Starts

2006-11-01

Expected to finish

2010-03-01

Last updated by the study team

2011-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants >=18 years of age and in good health (Investigator discretion) with a recent stable medical history
• Diagnosis of UC for greater than 90 days prior to Baseline
• Diagnosis of active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy during the Screening Period, with exclusion of infection
• 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.
• 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.
• Had to be able to self-administer or had caregiver who could reliably administer subcutaneous (SC) injections.
• Had to be able and willing to give written informed consent and to comply with the requirements of the study protocol.
• 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.
• Judged to be in generally good health as determined by the Investigator

You may not qualify if…

• History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC, or planned bowel surgery.
• Received previous treatment with ADA or previous participation in an ADA clinical study.
• Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of Baseline.
• Received intravenous (IV) corticosteroids within 14 days of Screening or during the Screening Period.
• 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.
• Current diagnosis of fulminant colitis and/or toxic megacolon.
• Disease limited to the rectum (ulcerative proctitis).
• Current diagnosis of indeterminate colitis.
• Current diagnosis and/or history of Crohns disease (CD).
• Currently receiving total parenteral nutrition.
• 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.
• Positive Clostridium difficile stool assay.
• Previously used infliximab or any anti-TNF agent within 56 days of Baseline.
• Previously used infliximab or any anti-TNF agent without clinical response at any time ("primary non-responder") unless subject experienced a treatment-limiting reaction.
• 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.
• 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.
• 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).
• 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).
• 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.
• Received any investigational agent within 30 days or 5 half lives prior to Baseline (whichever was longer).
• History of clinically significant drug or alcohol abuse during the past year.
• Known hypersensitivity to the excipients of ADA as stated in the label.
• Any prior exposure to Tysabri® (natalizumab), or Orencia® (abatacept) or any other biological therapy [other than Kineret® (anakinra) and anti-TNF agents].
• Currently taking both budesonide and prednisone (or equivalent) simultaneously.

Where it is running

• Site Ref # / Investigator 3753 — Wheat Ridge, Colorado, United States
• Site Ref # / Investigator 3754 — Hamden, Connecticut, United States
• Site Ref # / Investigator 12903 — Gainesville, Florida, United States
• Site Ref # / Investigator 3747 — Hollywood, Florida, United States
• Site Ref # / Investigator 5106 — Jacksonville, Florida, United States
• Site Ref # / Investigator 11601 — Naples, Florida, United States
• Site Ref # / Investigator 6846 — Sarasota, Florida, United States
• Site Ref # / Investigator 3742 — Winter Park, Florida, United States
• Site Ref # / Investigator 3760 — Zephyrhills, Florida, United States
• Site Ref # / Investigator 3739 — Atlanta, Georgia, United States
• Site Ref # / Investigator 7658 — Macon, Georgia, United States
• Site Ref # / Investigator 5397 — Moline, Illinois, United States
• Site Ref # / Investigator 7453 — Topeka, Kansas, United States
• Site Ref # / Investigator 3759 — Annapolis, Maryland, United States
• Site Ref # / Investigator 3762 — Annapolis, Maryland, United States
• Site Ref # / Investigator 3738 — Lutherville, Maryland, United States
• Site Ref # / Investigator 7472 — Troy, Michigan, United States
• Site Ref # / Investigator 3744 — Rochester, Minnesota, United States
• Site Ref # / Investigator 6088 — St Louis, Missouri, United States
• Site Ref # / Investigator 3756 — Great Neck, New York, United States
• Site Ref # / Investigator 3752 — Charlotte, North Carolina, United States
• Site Ref # / Investigator 3758 — Jacksonville, North Carolina, United States
• Site Ref # / Investigator 3745 — Cincinnati, Ohio, United States
• Site Ref # / Investigator 7709 — Oklahoma City, Oklahoma, United States
• Site Ref # / Investigator 5394 — Anaheim, California, United States

Full record on ClinicalTrials.gov

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