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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00410410
Date of registration:	11/12/2006
Prospective Registration:	No
Primary sponsor:	Bristol-Myers Squibb
Public title:	A Study of Abatacept in Patients With Active Ulcerative Colitis
Scientific title:	A Phase 3, 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
Date of first enrolment:	December 2006
Target sample size:	591
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00410410
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
Argentina	Australia	Belgium	Brazil	Canada	Czech Republic	France	Germany
India	Ireland	Italy	Korea, Republic of	Mexico	Netherlands	Poland	Puerto Rico
South Africa	Spain	Switzerland	United Kingdom	United States

Contacts

Name:	Bristol-Myers Squibb
Address:
Telephone:
Email:
Affiliation:	Bristol-Myers Squibb

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men or women 18 years or older

- Ulcerative colitis for at lease 3 months

- Moderate to severe active ulcerative colitis

- Inadequate response or intolerance to standard ulcerative colitis treatment

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: abatacept (ABA)

Drug: abatacept

Drug: placebo

Primary Outcome(s)

OL; Number of Participants With Physical Examination Findings [Time Frame: Day OL-1 through Day OL-729]

OL; Number of Participants With AEs of Special Interest [Time Frame: Day OL-1 through Day OL-729]

OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities [Time Frame: Day OL-1 through Day OL-729]

OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities [Time Frame: Day OL-1 through Day OL-729]

Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) [Time Frame: Week 12 (Day IP-85)]

OL; Number of Participants With Marked Hematology Laboratory Abnormalities [Time Frame: Day OL-1 through Day OL-729]

Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 [Time Frame: Month 12 (Day MP-365)]

Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation [Time Frame: Day OL-1 through the end of the OL]

Secondary Outcome(s)

IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP1C [Time Frame: Day IP-1 through Day IP-85]

IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With Clinical Response At Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C [Time Frame: Week 12 (Day IP-85)]

MP; Number of Participants in Clinical Remission at Month 12 [Time Frame: Month 12 (Day MP-365)]

MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids and Achieved Clinical Remission by Month 12 [Time Frame: Day MP-365 (Month 12)]

IP; Number of Participants With Mayo Physician Global Assessment (PGA) Subscores Indicating Mild Disease (=1 Point) at Week 12: IP1C [Time Frame: Day IP-85 (Week 12)]

MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation [Time Frame: Day MP-1 through Day MP-365]

MP; Number of Participants With Clinical Remission at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) [Time Frame: Month 12 (Day MP-365)]

MP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (=1 Point) at Month 12 [Time Frame: Day MP-365 (Month 12)]

MP; Number of Participants With Physical Examination Findings [Time Frame: Day IP-85 through Day MP-365]

OL; Number of Participants With Clinical Response or Clinical Remission Upon Retreatment With Abatacept Among Those Who Received Abatacept in the IP or MP Period [Time Frame: Last Study Visit (Day OL-729)]

OL; Number of Participants With Clinical Response Over Time [Time Frame: Day OL-1 through Day OL-729]

OL; Number of Participants Using Corticosteroids During OL [Time Frame: Day OL-1 through Day OL-729]

IP; Baseline Mayo Score: IP1C [Time Frame: Baseline]

IP; Mean Change From Baseline To Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ): IP1C [Time Frame: Baseline (Day IP-1), Day IP-85 (Week 12)]

IP; Number of Participants in Mucosal Healing (Per Mayo Score) at Week 12: IP1C [Time Frame: Week 12 (Day IP-85)]

MP; Number of Participants With AEs of Special Interest [Time Frame: Day MP-1 through Day MP-365]

IP; Number of Participants in Clinical Remission (Per Mayo Score) at Week 12: IP1C [Time Frame: Week 12 (Day IP-85)]

IP; Number of Participants in Clinical Remission at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C [Time Frame: Week 12 (Day IP-85)]

IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C [Time Frame: For participants treated in MP: Day IP-1 (Baseline) to Day MP-1 (Day IP-85). For participants treated in OL directly after IP: Day IP-1 to Day OL-1. For participants treated only in IP: All measurements after Day IP-1 (including follow-up visits)]

IP; Number of Participants With Clinical Response (Per Mayo Score) at Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C [Time Frame: Week 12 (Day IP-85)]

IP; Number of Participants With Clinical Response At Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C [Time Frame: Week 12 (Day IP-85)]

IP; Number of Participants With Marked Hematology Laboratory Abnormalities: IP1C [Time Frame: Day IP-1 through Day IP-85]

IP; Number of Participants With Marked Hematology, Liver and Kidney Function, and Electrolyte Laboratory Abnormalities: IP2C [Time Frame: Day IP-1 through Day IP-85]

MP; Number of Participants With Clinical Mucosal Healing at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) [Time Frame: Month 12 (Day MP-365)]

MP; Number of Participants With Clinical Response at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) [Time Frame: Month 12 (Day MP-365)]

MP; Number of Participants With Marked Hematology Laboratory Abnormalities [Time Frame: Day IP-85 through Day MP-365]

MP; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (=1 Point) at Month 12 [Time Frame: Month 12 (Day MP-365)]

OL; Number of Participants With Clinical Remission Over Time [Time Frame: Day OL-1 through Day OL-729]

IP; Baseline Inflammatory Bowel Disease Questionnaire (IBDQ) Score: IP1C [Time Frame: Baseline]

IP; Number of Participants in Mucosal Healing at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C [Time Frame: Week 12 (Day IP-85)]

IP; Number of Participants With AEs Of Special Interest: IP1C + IP2C [Time Frame: Day IP-1 through Day IP-85]

IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP2C [Time Frame: Day IP-1 through Day IP-85]

IP; Number of Participants With Marked Liver and Kidney Function and Electrolyte Laboratory Abnormalities: IP1C [Time Frame: Day IP-1 through Day IP-85]

MP; Number of Participants With Abatacept-Induced Antibodies [Time Frame: For participants not entering OL: All measurements starting after Day MP-1 (including follow-up visits). For participants entering OL: From first measurement after Day MP-1 to Day MP-365 (Day OL-1).]

MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids for 90 Consecutive Days and Achieved Clinical Remission by Month 12 [Time Frame: Day MP-365 (Month 12)]

MP; Number of Participants With Mayo PGA Subscores Indicating Mild Disease (=1 Point) at Month 12 [Time Frame: Day MP-365 (Month 12)]

IP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (=1 Point) at Week 12: IP1C [Time Frame: Day IP-85 (Week 12)]

IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation: IP1C + IP2C [Time Frame: Day IP-1 through Day IP-85]

IP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (=1 Point) at Week 12: IP1C [Time Frame: Day IP-85 (Week 12)]

MP; Mean Change From Baseline to Month 12 in IBDQ [Time Frame: Day MP-365]

MP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (=1 Point) at Month 12 [Time Frame: Day MP-365 (Month 12)]

OL; Number of Participants With Abatacept-Induced Antibodies [Time Frame: For participants receiving OL medication, all measurements starting after Day OL-1 (including follow-up visits and at 56 and 85 days after last dose)]

OL; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (=1 Point) During OL [Time Frame: Open-Label Period (Day OL-1 through Day OL-729)]

MP; Mean Change From Baseline to Month 12 in Short Form-36 (SF-36) [Time Frame: Day MP-365]

MP; Number of Participants in Clinical Remission at Both Month 6 and Month 12 [Time Frame: Month 6 (Day MP-169), Month 12 (Day MP-365)]

IP; Number of Participants With Physical Examination Findings: IP1C + IP2C [Time Frame: Day IP-1 through Day IP-85]

MP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities [Time Frame: Day IP-85 through Day MP-365]

Secondary ID(s)

IM101-108

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	02/12/2010
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00410410

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