A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Phase 3

Conditions: Ulcerative Colitis (UC)
10017969

Registration Number: NL-OMON30798

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

1) Subject is willing to participate in the study and has signed the informed consent
2) Subject must have had ulcerative colitis (UC) for at least 3 months from the time of initial diagnosis. The diagnosis of UC must have been confirmed by endoscopic and histologic evidence. If no previous confirmation of diagnosis is available or if previous diagnosis is not deemed conclusive, at time of screening endoscopy, histology should be performed to confirm diagnosis of UC
3) Subjects must satisfy one of the following criteria:
a) In the past, had an inadequate response to one or more of the following treatments:
i) Oral aminosalicylates (e.g. mesalamine, sulfasalazine, olsalazine, balsalizide) at or above the approved label dose for at least 6 weeks, and/or
ii) Prednisone >= 40 mg/day (or equivalent) for at least 2 weeks, and/or
iii) Immunosuppressants [azathioprine >= 2 mg/kg/day or 6-mercaptopurine >= 1.0 mg/kg/day, (or documentation of a therapeutic concentration of 6-thioguanine nucleotide)] for at least 12 weeks, and/or
iv) An approved anti-TNF agent at an approved labeled dose for at least 8 weeks and/or
v) Intravenous hydrocortisone >= 400 mg/day (or equivalent) for at least 1 week.
AND/OR
b) had been intolerant to one or more of the above mentioned treatments [e.g, unable to achieve doses or treatment durations because of dose limiting side effects (e.g. leukopenia, psychosis, uncontrolled diabetes, elevated liver enzymes)]
AND/OR
c) Currently receiving one or more of the following treatments:
i) Oral aminosalicylates (e.g. mesalamine, sulfasalazine, olsalazine, balsalizide) at or above the approved label dose for at least 6 weeks and/or
ii) Prednisone >= 20 mg/day (or equivalent) for at least 4 weeks and/or
iii) Immunosuppressants [azathioprine >= 2 mg/kg/day or 6-mercaptopurine >= 1.0 mg/kg/day, (or documentation of a therapeutic concentration of 6 thioguanine nucleotide)] for at least 12 weeks.
4) Subjects must have a Mayo score >= 6 and an endoscopic subscore of >= 2
5) Men and women, ages >= 18

Exclusion Criteria

1) Diagnosis of Crohn*s Disease or Indeterminate Colitis or clinical findings suggestive of Crohn*s disease (i.e., fistula or granulomas on biopsy)
2) Diagnosis of ulcerative colitis that is limited to the rectum (ulcerative proctitis).
3) Current evidence of fulminant colitis, toxic megacolon or bowel perforation
4) Current need for colostomy or ileostomy
5) Previous total proctocolectomy or subtotal colectomy with ileorectal anastomosis, any surgical resection for UC
6) Surgical bowel resection within 6 months before screening for reasons other than UC
7) Primary sclerosing cholangitis (PSC)
8) Currently receiving total parenteral nutrition (TPN)
9) Required intravenous corticosteroids for UC two weeks before screening.
10) Past or current evidence of definite colonic dysplasia
11) Subjects who are scheduled or anticipate the need for surgery, aside from dermatologic procedures
12) Subjects who have a history of clinically significant drug or alcohol abuse
13) Concomitant illness that in the opinion of the Investigator, is likely to require systemic glucocorticosteroid therapy during the study (e.g. moderate to severe asthma)
14) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, pulmonary, cardiac, neurological, ophthalmologic or cerebral disease. Concomitant medical conditions that in the opinion of the Investigator might place the subject at unacceptable risk for participation in this study
15) Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to enrollment. Subjects with carcinoma in situ, treated with definitive surgical intervention, are allowed
16) Subjects at risk for tuberculosis (TB).
17) Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (such as chronic pyelonephritis, osteomyelitis and bronchiectasis)
18) Female subjects who have had a breast cancer screening that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations
19) A history of severe or anaphylactic infusion reaction after receiving a biologic agent, suspected to be associated with an immune response