Clinical trial NCT00406653: A Study of Abatacept in Patients With Active Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).
measure: Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months)
timeFrame: Day MP-365 (12 months) of maintenance therapy
measure: 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
timeFrame: Between Day OL-1 and Day OL-617
measure: OL; Number of Participants With Adverse Events (AEs) of Special Interest
timeFrame: Between Day OL-1 and Day OL-617
Secondary outcomes:
measure: IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome)
timeFrame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy
measure: 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
timeFrame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy
measure: IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Baseline, Day IP-85
measure: IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
timeFrame: Day IP-1 through Day IP-85
measure: IP; Number of Participants With Adverse Events (AEs) of Special Interest
timeFrame: Day IP-1 through Day IP-85
measure: IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)
timeFrame: 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)
measure: 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)
timeFrame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy
measure: 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
timeFrame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy
measure: 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
timeFrame: At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy
measure: MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs
timeFrame: Between Day IP-85 and Day MP-365
measure: MP; Number of Participants With Adverse Events (AEs) of Special Interest:
timeFrame: Between Day IP-85 and Day MP-365
measure: MP; Number of Participants With Positive Antibody Response to Abatacept
timeFrame: 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)
measure: MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365.
timeFrame: Day MP-365
measure: MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365
timeFrame: Day MP-169
measure: MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36)
timeFrame: Baseline, Day MP-365
measure: MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: Baseline, Day MP-365
measure: MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among All Participants Who Received Baseline Corticosteroid Therapy
timeFrame: Day MP-365
measure: 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
timeFrame: Day MP-365
measure: MP; Number of Participants With CDAI-Defined Clinical Response Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)
timeFrame: Day MP-365
measure: MP; Number of Participants in CDAI-Defined Clinical Remission Among Participants With Inadequate Response and/or Intolerance to Anti-TNF
timeFrame: Day MP-365
measure: OL; Number of Participants Who Were Not On Background Corticosteroid Therapy Among All Participants Who Received Baseline Corticosteroid Therapy
timeFrame: Between Day OL-1 and Day OL-617
measure: OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169
timeFrame: Day OL-169
measure: OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365
timeFrame: Day OL-365
measure: OL; Number of Participants With Positive Antibody Response to Abatacept
timeFrame: 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)
measure: OL; Number of Participants With Pharmacogenomic Marker Activity
timeFrame: Between Day OL-1 and Day OL-617
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama Medical Center
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: The Permanente Medical Group, Inc
state: California
city: Gainesville
country: United States
facility: University Of Florida
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Winter Park
country: United States
facility: Shafran Gasteroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Chicago
country: United States
facility: University Of Chicago Hospitals
state: Illinois
city: Pratt
country: United States
facility: Health Science Center
state: Kansas
city: Lexington
country: United States
facility: University Of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Gulf Coast Research Assoc
state: Louisiana
city: Lafayette
country: United States
facility: Vanderlick, Michael
state: Louisiana
city: Laurel
country: United States
facility: Maryland Digestive Disease Research
state: Maryland
city: Plymouth
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Gastroenterology And Hepatology
state: Missouri
city: Egg Harbor Twp
country: United States
facility: Aga Clinical Research Associates, Llc
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Clinical Research
state: New York
city: New York
country: United States
facility: Mount Sinai School Of Medicine
state: New York
city: Rochester
country: United States
facility: U Of Rochester Gastroenterology And Hepatology
state: New York
city: Syracuse
country: United States
facility: University Endoscopy Center
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology, Pllc
state: North Carolina
city: Winston Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Canton
country: United States
facility: Gastroenterology Specialists, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Consultants For Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Gastrointestinal & Liver Diseases Consultants
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research, Llc
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allegheny Center For Digestive Health
state: Pennsylvania
city: Chattanooga
country: United States
facility: Southeastern Clinical Research
state: Tennessee
city: Germantown
country: United States
facility: Gastroenterology Center Of The Midsouth, P.C.
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Group
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research
state: Tennessee
city: Austin
country: United States
facility: Austin Gastroenterology, Pa
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Clinic Of San Antonio
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Garran
country: Australia
facility: Local Institution
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Herston
country: Australia
facility: Local Institution
state: Queensland
city: South Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Bedford Park
country: Australia
facility: Local Institution
state: South Australia
city: Launceston
country: Australia
facility: Local Institution
state: Tasmania
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: Fitzroy
country: Australia
facility: Local Institution
state: Victoria
city: South Ballarat
country: Australia
facility: Local Institution
state: Victoria
city: Fremantle
country: Australia
facility: Local Institution
state: Western Australia
city: Bonheiden
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Roeselare
country: Belgium
facility: Local Institution
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Goiania
country: Brazil
facility: Local Institution
state: Goias
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: St Johns
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Ceske Budejovice
country: Czech Republic
facility: Local Institution
city: Aalborg
country: Denmark
facility: Local Institution
city: Arhus C
country: Denmark
facility: Local Institution
city: Hvidovre
country: Denmark
facility: Local Institution
city: Odense C
country: Denmark
facility: Local Institution
city: Amiens Cedex 1
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Nice
country: France
facility: Local Institution
city: Paris Cedex 10
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: Toulouse Cedex
country: France
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Muenster
country: Germany
facility: Local Institution
city: Muenster
country: Germany
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
state: Andhra Pradesh
city: Hyderabad
country: India
facility: Local Institution
city: Mangalore
country: India
facility: Local Institution
city: Manipal
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: Mysore
country: India
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: San Giovanni Rotondo
country: Italy
facility: Local Institution
city: Torreon
country: Mexico
facility: Local Institution
state: Coahuila
city: Mexico, D.F.
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Katowice
country: Poland
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Overport
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Belville
country: South Africa
facility: Local Institution
state: Western Cape
city: Bern
country: Switzerland
facility: Local Institution
city: Lausanne
country: Switzerland
facility: Local Institution
city: Zuerich
country: Switzerland
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Sandborn WJ, Colombel JF, Sands BE, Rutgeerts P, Targan SR, Panaccione R, Bressler B, Geboes K, Schreiber S, Aranda R, Gujrathi S, Luo A, Peng Y, Salter-Cid L, Hanauer SB. Abatacept for Crohn's disease and ulcerative colitis. Gastroenterology. 2012 Jul;143(1):62-69.e4. doi: 10.1053/j.gastro.2012.04.010. Epub 2012 Apr 12.