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.
- Conditions
- Moderately to severely active ulcerative colitis.MedDRA version: 8.1Level: LLTClassification code 10045365Term: Ulcerative colitis
- Registration Number
- EUCTR2006-002781-20-SK
- Lead Sponsor
- Abbott GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 575
1.Male or female 18 years of age.
2.Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.
3.Diagnosis of active ulcerative colitis confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy during the Screening Period, with exclusion of infection.
4.Active ulcerative colitis with a Mayo Score of 6-12 points and endoscopy subscore of 2-3 despite concurrent treatment with oral corticosteroids and/or immunosuppressants as defined below:
?Stable (± 5 mg) corticosteroid dose (prednisone of ³ 20 mg/day or equivalent) for at least 14 days prior to Baseline or maintenance corticosteroid dose (prednisone of ³ 10 mg/day and < 20 mg/day or equivalent) for at least 40 days prior to Baseline.
?At least a 90 day course of azathioprine or 6-MP prior to Baseline, with a dose of azathioprine ³ 1.5 mg/kg/day or 6-MP ³ 1 mg/kg/day (rounded to the nearest available tablet formulation), or a dose that is the highest tolerated by the subject (e.g., due to leukopenia, elevated liver enzymes, nausea) during that time. Subject must be on a stable dose for at least 28 days prior to Baseline.
Concurrent therapy will not be required for subjects who were previously treated with corticosteroids or immunosuppressants (azathioprine 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.Must be able to self-administer or has caregiver who can reliably administer subcutaneous injections.
6.Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
7.Female must 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 is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:
?Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
?Oral or parenteral contraceptives for 90 days prior to study drug administration
?A vasectomized partner
8.The results of the serum pregnancy test performed at the Screening Visit and urine pregnancy test performed at the Baseline Visit must be negative.
9.Judged to be in generally good health by the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 or 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint of this study is the proportion of subjects with remission at Week 8.
- Secondary Outcome Measures
Name Time Method