ACTRN12620000932965
Terminated
Phase 1
Phase 1 Open-Label Study to Assess Pharmacokinetic and Pharmacodynamic Parameters Following Dosing with an Anti-Tumor Necrosis Factor Monoclonal Antibody (Humira®, adalimumab) Enema in Patients with Active Ulcerative Colitis.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- lcerative colitis
- Sponsor
- Progenity Inc
- Enrollment
- 4
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must provide consent to participate in the study prior to any study procedures are performed
- •\- UC diagnosis for at least 3 months. .
- •\- Active colitis:
- •\- Drug stabilisation requirements, if on one or more of the following medications: oral corticosteroid treatment, oral aminosalicylates, Azathioprine or 6 mercaptopurine, Vedolizumab, Tofacitinib, Ustekinumab
- •\- Women of childbearing potential must agree to use birth control
Exclusion Criteria
- •\- Diagnosis of (or clinical findings suggestive of) Crohn’s disease or indeterminate colitis
- •\- Diagnosis of UC limited to rectum
- •\- Evidence of fulminant colitis
- •\- Need for colostomy or ileostomy (within 3 months)
- •\- Previous total or subtotal colectomy or any surgical resection
- •\- Prior exposure to adalimumab
- •\- Prior hypersensitivity reaction to any anti TNF therapy
- •\- Recent or current use of any anti TNF agent
- •\- Current rectal therapy for UC
- •\- Current use of intravenous corticosteroid for UC
Outcomes
Primary Outcomes
Not specified
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