Status:
UNKNOWN
Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis
Lead Sponsor:
Clalit Health Services
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (...
Detailed Description
Ulcerative colitis (UC) is one of the two primary forms of idiopathic inflammatory bowel disease (IBD). Recent studies have shown that TNF- α may play a major role in the etiopathogenesis of UC, justi...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years of age.
- Diagnosis of ulcerative colitis 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 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.
- Has to be able to self-administer subcutaneous injections or has caregiver who can reliably administer subcutaneous injections.
- Has to be able and willing to give written informed consent and to comply with the requirements of this study protocol.
Exclusion
- History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC or is planning bowel surgery.
- 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 Screening Period.
- Current diagnosis of fulminant colitis and/or toxic megacolon.
- Subject 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 (TPN).
- Subject 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.
- Subject with positive Clostridium difficile (C. difficile) stool assay.
- Subject who has previously used infliximab or any anti-TNF agent within 56 days of Baseline.
- Subject who has previously used infliximab or any anti-TNF agent and has not clinically responded at any time ("primary non-responder") unless subject experienced a treatment limiting reaction.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01494857
Start Date
January 1 2012
End Date
December 1 2013
Last Update
October 30 2012
Active Locations (3)
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1
Sherutey Briuth Clalit / Clalit HMO
Herzlyia, Israel
2
Lev Talpiot Clinic, Clalit health Services
Jerusalem, Israel
3
Zevulun Clinic, Clalit Health Services
Kiryat Bialik, Israel