Status:
COMPLETED
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis
Lead Sponsor:
Abbott
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.
Detailed Description
This was a Phase 3, multicenter, randomized, double-blind (DB), placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-TNF monoclonal antibody adalimumab for the induc...
Eligibility Criteria
Inclusion
- The following eligibility criteria applied to participants enrolled following Amendment 3 to the study protocol.
- Male and female participants \>= 18 years of age
- Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline
- Diagnosis of active ulcerative colitis 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 dose of \>= 20 mg/day or equivalent) for at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisone of \< 20 mg/day) for at least 40 days prior to Baseline.
- and/or
- At least a consecutive 90 day course of azathioprine or 6-mercaptopurine (6 MP) prior to Baseline, with a dose of azathioprine \>= 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 was to 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 (azathioprine or 6-MP) during the previous 5 years and, in the judgment of the investigator, have failed to respond to or could not tolerate their treatment.
- Had to be able to self-administer or has caregiver who can reliably administer subcutaneous injections.
- Had to be able and willing to give written informed consent and to comply with the requirements of this 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 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 or 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 had to be negative.
- Judged to be in generally good health as determined by the principal investigator
Exclusion
- History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis or is planning bowel surgery.
- Received infliximab or any other anti-TNF agent or any biological therapy in the past.
- Received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
- Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Baseline.
- Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
- Received therapeutic enema or suppository, other than required for endoscopy, within 14 days prior to the Screening endoscopy and during the remainder of the Screening Period.
- Current diagnosis of fulminant colitis and/or toxic megacolon.
- Participants with disease limited to the rectum (ulcerative proctitis).
- Current diagnosis of indeterminate colitis.
- Current diagnosis and/or history of Crohn's disease.
- Currently receiving total parenteral nutrition.
- Discontinued use of azathioprine or 6-MP within 28 days of Baseline.
- Discontinued use of corticosteroid within 14 days of Baseline.
- Participants using aminosalicylates for less than 90 days prior to Baseline, not on a stable dose for at least 28 days prior to Baseline, or discontinued use within 28 days of Baseline.
- Participants with positive Clostridium difficile stool assay.
- 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.
- 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, the participant was not to be enrolled in the study.
- History of listeria, histoplasmosis, chronic or active hepatitis B infection, human immunodeficiency virus, immunodeficiency syndrome, central nervous system demyelinating disease, or untreated tuberculosis (TB).
- Female participants who was 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.
- Poorly controlled medical condition(s), such as uncontrolled diabetes, unstable ischemic heart disease, moderate to severe congestive heart failure, recent cerebrovascular accident and any other condition, which in the opinion of the investigator, would put the participant at risk by participation in the protocol.
- Received any investigational agent within 30 days or 5 half lives prior to Baseline (whichever is longer).
- History of clinically significant drug or alcohol abuse during the previous year.
- Participants with known hypersensitivity to the excipients of adalimumab as stated in the label.
- Participants with any prior exposure to Tysabri® (natalizumab).
- Participants currently taking both budesonide and prednisone (or equivalent) simultaneously.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT00385736
Start Date
November 1 2006
End Date
March 1 2010
Last Update
April 11 2011
Active Locations (80)
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1
Site Ref # / Investigator 2080
Birmingham, Alabama, United States, 35209
2
Site Ref # / Investigator 6034
Mobile, Alabama, United States, 36617
3
Site Ref # / Investigator 5100
Fayetteville, Arkansas, United States, 72703
4
Site Ref # / Investigator 5390
Orange, California, United States, 92868