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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00406653




Registration number
NCT00406653
Ethics application status
Date submitted
1/12/2006
Date registered
4/12/2006
Date last updated
14/09/2010

Titles & IDs
Public title
A Study of Abatacept in Patients With Active Crohn's Disease
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 Crohn's Disease (CD) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy
Secondary ID [1] 0 0
IM101-084
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - abatacept
Treatment: Drugs - placebo
Treatment: Drugs - abatacept

Experimental: 1 - 4 arms for induction period

2 arms for maintenance period

Placebo comparator: 2 - 4 arms for induction period

2 arms for maintenance period

Other: abatacept - 1 arm for open-label extension phase


Treatment: Drugs: 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

Treatment: Drugs: placebo
Normal saline, IV, 0 mg/kg, every 28 days.

Induction Period 3 months

Maintenance Period 12 months

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12).
Primary outcome [2] 0 0
Maintenance Period (MP); Number of Participants In CDAI-Defined Clinical Remission (CDAI <150) at Day MP-365 (12 Months)
Timepoint [2] 0 0
Day MP-365 (12 months) of maintenance therapy
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Between Day OL-1 and Day OL-617
Primary outcome [4] 0 0
OL; Number of Participants With Adverse Events (AEs) of Special Interest
Timepoint [4] 0 0
Between Day OL-1 and Day OL-617
Secondary outcome [1] 0 0
IP; Number of Participants in CDAI-defined Clinical Remission at Both Day IP-57 and Day IP-85 (Key Secondary Outcome)
Timepoint [1] 0 0
At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy
Secondary outcome [3] 0 0
IP; Change From Baseline to Day IP-85 In Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [3] 0 0
Baseline, Day IP-85
Secondary outcome [4] 0 0
IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due to AEs
Timepoint [4] 0 0
Day IP-1 through Day IP-85
Secondary outcome [5] 0 0
IP; Number of Participants With Adverse Events (AEs) of Special Interest
Timepoint [5] 0 0
Day IP-1 through Day IP-85
Secondary outcome [6] 0 0
IP; Number of Participants With Positive Antibody Response to Abatacept (ABA)
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
At both Day IP-57 (Wk 8) and Day IP-85 (Wk 12) of induction therapy
Secondary outcome [10] 0 0
MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and Discontinuation Due To AEs
Timepoint [10] 0 0
Between Day IP-85 and Day MP-365
Secondary outcome [11] 0 0
MP; Number of Participants With Adverse Events (AEs) of Special Interest:
Timepoint [11] 0 0
Between Day IP-85 and Day MP-365
Secondary outcome [12] 0 0
MP; Number of Participants With Positive Antibody Response to Abatacept
Timepoint [12] 0 0
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)
Secondary outcome [13] 0 0
MP; Number of Participants With CDAI-defined Clinical Response at Day MP-365.
Timepoint [13] 0 0
Day MP-365
Secondary outcome [14] 0 0
MP; Number of Participants in CDAI-defined Clinical Remission at Both Day MP-169 and Day MP-365
Timepoint [14] 0 0
Day MP-169
Secondary outcome [15] 0 0
MP; Change From Baseline to Day MP-365 in Short Form-36 (SF-36)
Timepoint [15] 0 0
Baseline, Day MP-365
Secondary outcome [16] 0 0
MP; Change From Baseline to Day MP-365 in Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [16] 0 0
Baseline, Day MP-365
Secondary outcome [17] 0 0
MP; Number of Participants Who Were Not On Background Corticosteroid Therapy at Day MP-365 Among All Participants Who Received Baseline Corticosteroid Therapy
Timepoint [17] 0 0
Day MP-365
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Day MP-365
Secondary outcome [19] 0 0
MP; Number of Participants With CDAI-Defined Clinical Response Among Participants With Inadequate Response and/or Intolerance to Anti-Tumor Necrosis Factor (TNF)
Timepoint [19] 0 0
Day MP-365
Secondary outcome [20] 0 0
MP; Number of Participants in CDAI-Defined Clinical Remission Among Participants With Inadequate Response and/or Intolerance to Anti-TNF
Timepoint [20] 0 0
Day MP-365
Secondary outcome [21] 0 0
OL; Number of Participants Who Were Not On Background Corticosteroid Therapy Among All Participants Who Received Baseline Corticosteroid Therapy
Timepoint [21] 0 0
Between Day OL-1 and Day OL-617
Secondary outcome [22] 0 0
OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-169
Timepoint [22] 0 0
Day OL-169
Secondary outcome [23] 0 0
OL; Number of Participants With CDAI-defined Clinical Response or Clinical Remission at Day OL-365
Timepoint [23] 0 0
Day OL-365
Secondary outcome [24] 0 0
OL; Number of Participants With Positive Antibody Response to Abatacept
Timepoint [24] 0 0
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)
Secondary outcome [25] 0 0
OL; Number of Participants With Pharmacogenomic Marker Activity
Timepoint [25] 0 0
Between Day OL-1 and Day OL-617

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
Accrual to date
Final
451
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Camperdown
Recruitment hospital [3] 0 0
Local Institution - Herston
Recruitment hospital [4] 0 0
Local Institution - South Brisbane
Recruitment hospital [5] 0 0
Local Institution - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - Launceston
Recruitment hospital [7] 0 0
Local Institution - Box Hill
Recruitment hospital [8] 0 0
Local Institution - Fitzroy
Recruitment hospital [9] 0 0
Local Institution - South Ballarat
Recruitment hospital [10] 0 0
Local Institution - Fremantle
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
7250 - Launceston
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3065 VIC - Fitzroy
Recruitment postcode(s) [9] 0 0
3350 - South Ballarat
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
Country [16] 0 0
United States of America
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Oklahoma
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United States of America
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Pennsylvania
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Tennessee
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Texas
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Washington
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Belgium
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Bonheiden
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Belgium
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Leuven
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Belgium
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Roeselare
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Bahia
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Goias
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Parana
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Aalborg
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Hvidovre
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Germany
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Muenster
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Mysore
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Napoli
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Padova
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Roma
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San Giovanni Rotondo
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Zuerich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00406653
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00406653