A Study of Abatacept in Patients With Active Crohn's Disease

Crohn's Disease Clinical Trial

Official 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 Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00406653
• Other study ID #: IM101-084
• Status: Terminated
• Phase: Phase 3
• First received: December 1, 2006
• Last updated: September 10, 2010
• Start date: December 2006
• Est. completion date: November 2009

Study information

• Verified date: September 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 451
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• have had Crohn's Disease for at least 3 months

• moderate to severely active Crohn's Disease

• have had an inadequate response or intolerance to other Crohn's Disease treatments

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• abatacept
Dextrose 5% in water, intravenous (IV). Placebo on days Induction Period (IP)-1, IP-15,IP-29, IP-57; 3 mg/kg on days IP-1, IP-15,IP-29, IP-57; ~10 mg/kg on days IP-1, IP-15,IP-29, IP-57, or 30 mg/kg on days IP-1,IP-15 and ~10 mg/kg on days IP-29, IP-57. Induction Period 3 months Maintenance Period 12 months
• placebo
Normal saline, IV, 0 mg/kg, every 28 days. Induction Period 3 months Maintenance Period 12 months
• abatacept
~10 mg/kg, every 28 days. Open- Label Extension Period until the drug is marketed for Crohn's Disease (CD)or the CD development program for abatacept is discontinued

Locations

Country	Name	City	State
Australia	Local Institution	Bedford Park	South Australia
Australia	Local Institution	Box Hill	Victoria
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Fitzroy	Victoria
Australia	Local Institution	Fremantle	Western Australia
Australia	Local Institution	Garran	Australian Capital Territory
Australia	Local Institution	Herston	Queensland
Australia	Local Institution	Launceston	Tasmania
Australia	Local Institution	South Ballarat	Victoria
Australia	Local Institution	South Brisbane	Queensland
Belgium	Local Institution	Bonheiden
Belgium	Local Institution	Leuven
Belgium	Local Institution	Roeselare
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Goiania	Goias
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	Sao Paulo
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Halifax	Nova Scotia
Canada	Local Institution	London	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	St Johns	Newfoundland and Labrador
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Czech Republic	Local Institution	Ceske Budejovice
Denmark	Local Institution	Aalborg
Denmark	Local Institution	Arhus C
Denmark	Local Institution	Hvidovre
Denmark	Local Institution	Odense C
France	Local Institution	Amiens Cedex 1
France	Local Institution	Lille Cedex
France	Local Institution	Nice
France	Local Institution	Paris Cedex 10
France	Local Institution	Pessac
France	Local Institution	Toulouse Cedex
Germany	Local Institution	Kiel
Germany	Local Institution	Muenster
Germany	Local Institution	Muenster
India	Local Institution	Hyderabad	Andhra Pradesh
India	Local Institution	Hyderabad
India	Local Institution	Mangalore
India	Local Institution	Manipal
India	Local Institution	Mumbai
India	Local Institution	Mysore
Italy	Local Institution	Napoli
Italy	Local Institution	Padova
Italy	Local Institution	Roma
Italy	Local Institution	San Giovanni Rotondo
Mexico	Local Institution	Mexico, D.F.	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Torreon	Coahuila
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Groningen
Netherlands	Local Institution	Rotterdam
Poland	Local Institution	Katowice
Puerto Rico	Local Institution	Ponce
South Africa	Local Institution	Belville	Western Cape
South Africa	Local Institution	Overport	Kwa Zulu Natal
Switzerland	Local Institution	Bern
Switzerland	Local Institution	Lausanne
Switzerland	Local Institution	Zuerich
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Austin Gastroenterology, Pa	Austin	Texas
United States	Gulf Coast Research Assoc	Baton Rouge	Louisiana
United States	University Of Alabama Medical Center	Birmingham	Alabama
United States	Gastroenterology Specialists, Inc.	Canton	Ohio
United States	University Of North Carolina At Chapel Hill	Chapel Hill	North Carolina
United States	Charlotte Gastroenterology & Hepatology, Pllc	Charlotte	North Carolina
United States	Southeastern Clinical Research	Chattanooga	Tennessee
United States	University Of Chicago Hospitals	Chicago	Illinois
United States	Consultants For Clinical Research	Cincinnati	Ohio
United States	Gastrointestinal & Liver Diseases Consultants	Dayton	Ohio
United States	Aga Clinical Research Associates, Llc	Egg Harbor Twp	New Jersey
United States	University Of Florida	Gainesville	Florida
United States	Gastroenterology Center Of The Midsouth, P.C.	Germantown	Tennessee
United States	Memphis Gastroenterology Group	Germantown	Tennessee
United States	Long Island Clinical Research	Great Neck	New York
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Kansas City Gastroenterology And Hepatology	Kansas City	Missouri
United States	Vanderlick, Michael	Lafayette	Louisiana
United States	Maryland Digestive Disease Research	Laurel	Maryland
United States	University Of Kentucky Medical Center	Lexington	Kentucky
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University Of Louisville	Louisville	Kentucky
United States	Nashville Medical Research	Nashville	Tennessee
United States	Mount Sinai School Of Medicine	New York	New York
United States	Allegheny Center For Digestive Health	Pittsburgh	Pennsylvania
United States	Minnesota Gastroenterology, P.A.	Plymouth	Minnesota
United States	Health Science Center	Pratt	Kansas
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	U Of Rochester Gastroenterology And Hepatology	Rochester	New York
United States	The Permanente Medical Group, Inc	Sacramento	California
United States	Gastroenterology Clinic Of San Antonio	San Antonio	Texas
United States	Virginia Mason Medical Center	Seattle	Washington
United States	University Endoscopy Center	Syracuse	New York
United States	Options Health Research, Llc	Tulsa	Oklahoma
United States	Piedmont Medical Research Associates	Winston Salem	North Carolina
United States	Shafran Gasteroenterology Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czech Republic,  Denmark,  France,  Germany,  India,  Italy,  Mexico,  Netherlands,  Poland,  Puerto Rico,  South Africa,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction Period (IP); Number of Participants With Crohn's Disease Activity Index (CDAI)-Defined Clinical Response at Both Day IP-57 and Day IP-85	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).	No
Primary	Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months)	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	Day MP-365 (12 months) of maintenance therapy	No
Primary	Open-Label Extension Period (OL); Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.	Between Day OL-1 and Day OL-617	Yes
Primary	OL; Number of Participants With Adverse Events (AEs) of Special Interest	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).	Between Day OL-1 and Day OL-617	Yes
Secondary	IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome)	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy	No
Secondary	IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy	No
Secondary	IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ)	The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-Baseline - Baseline value.	Baseline, Day IP-85	No
Secondary	IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.	Day IP-1 through Day IP-85	Yes
Secondary	IP; Number of Participants With Adverse Events (AEs) of Special Interest	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).	Day IP-1 through Day IP-85	Yes
Secondary	IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)	A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition identified specific anti-ABA reactivity. Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) and Possibly immunoglobulin (Ig) category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.	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)	No
Secondary	IP; Number of Participants With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy	No
Secondary	IP; Number of Participants in CDAI-Defined Clinical Remission at Both Day IP-57 and Day IP-85 Among Participants With Inadequate Response and/or Intolerance to Anti-TNF	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy	No
Secondary	IP; Number of Participants Who Are Anti-TNF-Inadequate Responders/Anti-TNF Intolerant With CDAI-Defined Clinical Response at Both Day IP-57 and Day IP-85 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy	No
Secondary	MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.	Between Day IP-85 and Day MP-365	Yes
Secondary	MP; Number of Participants With Adverse Events (AEs) of Special Interest:	AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).	Between Day IP-85 and Day MP-365	Yes
Secondary	MP; Number of Participants With Positive Antibody Response to Abatacept	A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.	For participants not entering OL: All measurements 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)	No
Secondary	MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365.	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	Day MP-365	No
Secondary	MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	Day MP-169	No
Secondary	MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36)	The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.	Baseline, Day MP-365	No
Secondary	MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ)	The Inflammatory Bowel Disease Questionnaire (IBDQ) consists of a self-administered 32-item questionnaire evaluating quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. Responses to each question can range from 1 to 7, with 1 indicating severe problem and 7 indicating normal health. The total IBDQ is computed as the sum of the responses to the individual IBDQ questions. The total score ranges between 32 to 224 with higher scores indicating a better quality of life. Change from Baseline= post-baseline - Baseline value.	Baseline, Day MP-365	No
Secondary	MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among All Participants Who Received Baseline Corticosteroid Therapy	Participants who received corticosteroid therapy (e.g. prednisone or budesonide) were to maintain a stable dose until Day MP-1. On or after Day MP-1, a recommended tapering regimen of corticosteroid therapy was planned if the participant was in remission (i.e., CDAI score < 150), or if the participant's condition had satisfactorily improved according to investigators clinical assessment. Other CD therapy was to remain at a stable dose throughout the Maintenance Period, with the exception of decreases due to drug-related toxicities.	Day MP-365	No
Secondary	MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among Participants Who Received Baseline Corticosteroid Therapy and Who Achieved CDAI-Defined Clinical Remission	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score is based partly on entries from participant's Diary (7 days before evaluation) which is kept while on study. CDAI scores range from 0 to ~600. Clinical response=CDAI reduction =100 or absolute CDAI <150. Clinical remission=CDAI <150. Moderate to severe disease=CDAI =220 and =450.	Day MP-365	No
Secondary	MP; Number of Participants With CDAI-Defined Clinical Response Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	Day MP-365	No
Secondary	MP; Number of Participants in CDAI-Defined Clinical Remission Among Participants With Inadequate Response and/or Intolerance to Anti-TNF	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	Day MP-365	No
Secondary	OL; Number of Participants Who Were Not On Background Corticosteroid Therapy Among All Participants Who Received Baseline Corticosteroid Therapy	Background corticosteroid therapy included prednisone or budesonide.	Between Day OL-1 and Day OL-617	No
Secondary	OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	Day OL-169	No
Secondary	OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365	CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to ~600 points. Clinical response=CDAI reduction =100 points or absolute CDAI <150 points. Clinical remission=CDAI <150 points. Moderate to severe disease=CDAI =220 and =450 points.	Day OL-365	No
Secondary	OL; Number of Participants With Positive Antibody Response to Abatacept	A electrochemiluminescent immunoassay screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly Ig category= reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.	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)	No
Secondary	OL; Number of Participants With Pharmacogenomic Marker Activity	Changes in the expression of individual ribonucleic acid (RNA) transcripts were to be evaluated from whole blood using both microarray transcriptional profiling and quantitative polymerase chain reaction (PCR) methods. Peripheral RNA transcriptional profiling was to be used only to identify individual RNA transcripts that differ in expression with respect to time, treatment and outcome.	Between Day OL-1 and Day OL-617	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm