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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00410410
Registration number
NCT00410410
Ethics application status
Date submitted
11/12/2006
Date registered
12/12/2006
Date last updated
24/03/2015
Titles & IDs
Public title
A Study of Abatacept in Patients With Active Ulcerative Colitis
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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
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Secondary ID [1]
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IM101-108
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - abatacept (ABA)
Treatment: Drugs - placebo
Treatment: Drugs - abatacept
Experimental: Abatacept (ABA) - Induction Period; 3 arms for Cohort 1: ABA 30/~10 mg/kg (ABA administered at 30 mg/kg followed by ABA at ~10 mg/kg), ABA ~10 mg/kg, ABA 3 mg/kg
Induction Period; 2 arms for Cohort 2: ABA 30/~10 mg/kg and Second Cohort ABA ~10 mg/kg
1 arm for maintenance period (ABA ~10 mg/kg)
Placebo Comparator: Placebo - 1 arm for induction period
1 arm for maintenance period
Other: abatacept - 1 arm for open-label extension phase (ABA ~10 mg/kg)
Treatment: Drugs: abatacept (ABA)
Dextrose 5% in water, IV. Placebo on days 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 (ABA 30/~10 mg/kg Group).
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, once monthly
Open- Label Extension Period until the drug is marketed for UC or the UC development program for abatacept is discontinued
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C)
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Assessment method [1]
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The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of = 3 points and = 30%, with an accompanying decrease in the rectal bleeding subscore of = 1 point or absolute rectal bleeding subscore of = 1 point.
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Timepoint [1]
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Week 12 (Day IP-85)
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Primary outcome [2]
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Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12
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Assessment method [2]
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The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of = 3 points and = 30%, with an accompanying decrease in the rectal bleeding subscore of = 1 point or absolute rectal bleeding subscore of = 1 point.
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Timepoint [2]
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Month 12 (Day MP-365)
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Primary outcome [3]
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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
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Assessment method [3]
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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.
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Timepoint [3]
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Day OL-1 through the end of the OL
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Primary outcome [4]
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OL; Number of Participants With AEs of Special Interest
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Assessment method [4]
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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).
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Timepoint [4]
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Day OL-1 through Day OL-729
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Primary outcome [5]
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OL; Number of Participants With Physical Examination Findings
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Assessment method [5]
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Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).
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Timepoint [5]
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Day OL-1 through Day OL-729
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Primary outcome [6]
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OL; Number of Participants With Marked Hematology Laboratory Abnormalities
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Assessment method [6]
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High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.
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Timepoint [6]
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Day OL-1 through Day OL-729
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Primary outcome [7]
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OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities
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Assessment method [7]
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Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN
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Timepoint [7]
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Day OL-1 through Day OL-729
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Primary outcome [8]
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OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities
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Assessment method [8]
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Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use =2 when BL value missing or value =4, or when pre-dose=0 or 0.5. Use =3 when pre-dose=1. Use =4 when pre-dose=2 or 3
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Timepoint [8]
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Day OL-1 through Day OL-729
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Secondary outcome [1]
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IP; Baseline Mayo Score: IP1C
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Assessment method [1]
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The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of = 3 points and = 30%, with an accompanying decrease in the rectal bleeding subscore of = 1 point or absolute rectal bleeding subscore of = 1 point.
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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IP; Number of Participants in Clinical Remission (Per Mayo Score) at Week 12: IP1C
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Assessment method [2]
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The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of = 2 points with no individual subscore exceeding 1 point.
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Timepoint [2]
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Week 12 (Day IP-85)
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Secondary outcome [3]
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IP; Number of Participants in Mucosal Healing (Per Mayo Score) at Week 12: IP1C
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Assessment method [3]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore = 1 point
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Timepoint [3]
0
0
Week 12 (Day IP-85)
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Secondary outcome [4]
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IP; Number of Participants With Clinical Response (Per Mayo Score) at Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C
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Assessment method [4]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of = 3 points and = 30%, with an accompanying decrease in the rectal bleeding subscore of = 1 point or absolute rectal bleeding subscore of = 1 point.
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Timepoint [4]
0
0
Week 12 (Day IP-85)
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Secondary outcome [5]
0
0
IP; Baseline Inflammatory Bowel Disease Questionnaire (IBDQ) Score: IP1C
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Assessment method [5]
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The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response 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 can range between 32 to 224 with higher scores indicating a better quality of life.
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Timepoint [5]
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0
Baseline
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Secondary outcome [6]
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IP; Mean Change From Baseline To Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ): IP1C
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Assessment method [6]
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0
The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response 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 can range between 32 to 224 with higher scores indicating a better quality of life.
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Timepoint [6]
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0
Baseline (Day IP-1), Day IP-85 (Week 12)
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Secondary outcome [7]
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IP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (=1 Point) at Week 12: IP1C
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Assessment method [7]
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The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of =1 point was indicative of mild disease.
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Timepoint [7]
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0
Day IP-85 (Week 12)
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Secondary outcome [8]
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IP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (=1 Point) at Week 12: IP1C
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Assessment method [8]
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The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of =1 point was indicative of mild disease.
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Timepoint [8]
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0
Day IP-85 (Week 12)
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Secondary outcome [9]
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IP; Number of Participants With Mayo Physician Global Assessment (PGA) Subscores Indicating Mild Disease (=1 Point) at Week 12: IP1C
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Assessment method [9]
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The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of =1 point was indicative of mild disease.
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Timepoint [9]
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0
Day IP-85 (Week 12)
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Secondary outcome [10]
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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
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Assessment method [10]
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0
The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of = 3 points and = 30%, with accompanying decrease in the rectal bleeding subscore of = 1 point or absolute rectal bleeding subscore of = 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for =8 weeks.
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Timepoint [10]
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Week 12 (Day IP-85)
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Secondary outcome [11]
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IP; Number of Participants With Clinical Response At Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C
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Assessment method [11]
0
0
The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of = 3 points and = 30%, with accompanying decrease in the rectal bleeding subscore of = 1 point or absolute rectal bleeding subscore of = 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for =8 weeks.
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Timepoint [11]
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0
Week 12 (Day IP-85)
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Secondary outcome [12]
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IP; Number of Participants in Clinical Remission at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C
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Assessment method [12]
0
0
The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of = 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance
=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for =8 weeks.
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Timepoint [12]
0
0
Week 12 (Day IP-85)
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Secondary outcome [13]
0
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IP; Number of Participants in Mucosal Healing at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C
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Assessment method [13]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore = 1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for =8 weeks.
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Timepoint [13]
0
0
Week 12 (Day IP-85)
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Secondary outcome [14]
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0
IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation: IP1C + IP2C
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Assessment method [14]
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0
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.
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Timepoint [14]
0
0
Day IP-1 through Day IP-85
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Secondary outcome [15]
0
0
IP; Number of Participants With AEs Of Special Interest: IP1C + IP2C
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Assessment method [15]
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0
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).
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Timepoint [15]
0
0
Day IP-1 through Day IP-85
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Secondary outcome [16]
0
0
IP; Number of Participants With Physical Examination Findings: IP1C + IP2C
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Assessment method [16]
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0
Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).
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Timepoint [16]
0
0
Day IP-1 through Day IP-85
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Secondary outcome [17]
0
0
IP; Number of Participants With Marked Hematology Laboratory Abnormalities: IP1C
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Assessment method [17]
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0
High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL.
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Timepoint [17]
0
0
Day IP-1 through Day IP-85
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Secondary outcome [18]
0
0
IP; Number of Participants With Marked Liver and Kidney Function and Electrolyte Laboratory Abnormalities: IP1C
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Assessment method [18]
0
0
Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; calcium (Ca): <0.8 x LLN/>1.2 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN
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Timepoint [18]
0
0
Day IP-1 through Day IP-85
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Secondary outcome [19]
0
0
IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP1C
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Assessment method [19]
0
0
Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use =2 when BL value missing or value =4, or when pre-dose=0 or 0.5. Use =3 when pre-dose=1. Use =4 when pre-dose=2 or 3
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Timepoint [19]
0
0
Day IP-1 through Day IP-85
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Secondary outcome [20]
0
0
IP; Number of Participants With Marked Hematology, Liver and Kidney Function, and Electrolyte Laboratory Abnormalities: IP2C
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Assessment method [20]
0
0
High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; Sodium (Na): <0.95 x LLN/ >1.05 x ULN; potassium (K): <0.9 x LLN/ >1.1 x ULN; phosphorous (P): <0.75 x LLN/ >1.2 5 x ULN;
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Timepoint [20]
0
0
Day IP-1 through Day IP-85
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Secondary outcome [21]
0
0
IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP2C
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Assessment method [21]
0
0
Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use =2 when BL value missing or value =4, or when pre-dose=0 or 0.5. Use =3 when pre-dose=1. Use =4 when pre-dose=2 or 3
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Timepoint [21]
0
0
Day IP-1 through Day IP-85
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Secondary outcome [22]
0
0
IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C
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Assessment method [22]
0
0
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.
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Timepoint [22]
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)
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Secondary outcome [23]
0
0
MP; Number of Participants in Clinical Remission at Month 12
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Assessment method [23]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of = 2 points with no individual subscore exceeding 1 point.
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Timepoint [23]
0
0
Month 12 (Day MP-365)
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Secondary outcome [24]
0
0
MP; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (=1 Point) at Month 12
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Assessment method [24]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore = 1 point
Query!
Timepoint [24]
0
0
Month 12 (Day MP-365)
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Secondary outcome [25]
0
0
MP; Number of Participants in Clinical Remission at Both Month 6 and Month 12
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Assessment method [25]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of = 2 points with no individual subscore exceeding 1 point.
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Timepoint [25]
0
0
Month 6 (Day MP-169), Month 12 (Day MP-365)
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Secondary outcome [26]
0
0
MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids and Achieved Clinical Remission by Month 12
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Assessment method [26]
0
0
Baseline corticosteroids equivalent of =30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of = 2 points with no individual subscore exceeding 1 point.
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Timepoint [26]
0
0
Day MP-365 (Month 12)
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Secondary outcome [27]
0
0
MP; Mean Change From Baseline to Month 12 in IBDQ
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Assessment method [27]
0
0
The Inflammatory Bowel Disease Questionnaire (IBDQ) was used to measure disease specific quality of life. The IBDQ consists of a self-administered 32-item questionnaire that evaluates quality of life across 4 dimensional scores: Bowel, Systemic, Social and Emotional. The response 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 can range between 32 to 224 with higher scores indicating a better quality of life.
Query!
Timepoint [27]
0
0
Day MP-365
Query!
Secondary outcome [28]
0
0
MP; Mean Change From Baseline to Month 12 in Short Form-36 (SF-36)
Query!
Assessment method [28]
0
0
The SF-36 is a validated instrument to measure health-related quality of life across multiple disease states. Individual subscale scores and 2 summary scores are calculated: (1) physical component summary (PCS) which includes physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS) which includes vitality, social functioning, role-emotional, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight, with values ranging from worse health (0) to best health (100).
Query!
Timepoint [28]
0
0
Day MP-365
Query!
Secondary outcome [29]
0
0
MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids for 90 Consecutive Days and Achieved Clinical Remission by Month 12
Query!
Assessment method [29]
0
0
Baseline corticosteroids equivalent of =30 mg prednisone daily. The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater frequency or severity. Clinical remission is defined as a Mayo score of = 2 points with no individual subscore exceeding 1 point.
Query!
Timepoint [29]
0
0
Day MP-365 (Month 12)
Query!
Secondary outcome [30]
0
0
MP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (=1 Point) at Month 12
Query!
Assessment method [30]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute rectal bleeding subscore of =1 point was indicative of mild disease.
Query!
Timepoint [30]
0
0
Day MP-365 (Month 12)
Query!
Secondary outcome [31]
0
0
MP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (=1 Point) at Month 12
Query!
Assessment method [31]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute stool frequency subscore of =1 point was indicative of mild disease.
Query!
Timepoint [31]
0
0
Day MP-365 (Month 12)
Query!
Secondary outcome [32]
0
0
MP; Number of Participants With Mayo PGA Subscores Indicating Mild Disease (=1 Point) at Month 12
Query!
Assessment method [32]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. An absolute PGA subscore of =1 point was indicative of mild disease.
Query!
Timepoint [32]
0
0
Day MP-365 (Month 12)
Query!
Secondary outcome [33]
0
0
MP; Number of Participants With Clinical Response at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)
Query!
Assessment method [33]
0
0
The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of = 3 points and = 30%, with accompanying decrease in the rectal bleeding subscore of = 1 point or absolute rectal bleeding subscore of = 1 point. Inadequate response/intolerance=inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for =8 weeks.
Query!
Timepoint [33]
0
0
Month 12 (Day MP-365)
Query!
Secondary outcome [34]
0
0
MP; Number of Participants With Clinical Remission at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)
Query!
Assessment method [34]
0
0
The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical remission is defined as a Mayo score of = 2 points with no individual subscore exceeding 1 point. Inadequate response/intolerance =inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for =8 weeks.
Query!
Timepoint [34]
0
0
Month 12 (Day MP-365)
Query!
Secondary outcome [35]
0
0
MP; Number of Participants With Clinical Mucosal Healing at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab)
Query!
Assessment method [35]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore =1 point. Inadequate response/intolerance = inadequate response/intolerance to an approved anti-TNF agent prior to this study at an approved labeled dose for =8 weeks.
Query!
Timepoint [35]
0
0
Month 12 (Day MP-365)
Query!
Secondary outcome [36]
0
0
MP; Number of Participants With Abatacept-Induced Antibodies
Query!
Assessment method [36]
0
0
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.
Query!
Timepoint [36]
0
0
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).
Query!
Secondary outcome [37]
0
0
MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation
Query!
Assessment method [37]
0
0
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.
Query!
Timepoint [37]
0
0
Day MP-1 through Day MP-365
Query!
Secondary outcome [38]
0
0
MP; Number of Participants With AEs of Special Interest
Query!
Assessment method [38]
0
0
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).
Query!
Timepoint [38]
0
0
Day MP-1 through Day MP-365
Query!
Secondary outcome [39]
0
0
MP; Number of Participants With Physical Examination Findings
Query!
Assessment method [39]
0
0
Complete physical examination was obtained at the Screening Visit, Day MP-365, and OL Final Visit/Early Termination visits. Interim physical examinations were performed at other study visits. Interim physical exam were not as comprehensive as the initial full examination but did note any changes in the participant's condition since the last assessment and did not preclude examination of any of the body systems as clinically indicated. Participants were observed for AEs and vital signs (blood pressure, heart rate, and temperature).
Query!
Timepoint [39]
0
0
Day IP-85 through Day MP-365
Query!
Secondary outcome [40]
0
0
MP; Number of Participants With Marked Hematology Laboratory Abnormalities
Query!
Assessment method [40]
0
0
High=greater than ULN, Low=lower than LLN. LLN/ULN= HGB: >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; PLT: <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; GGT: >2 x ULN; Bilirubin: >2 x ULN; BUN: >2 x BL; Na: <0.95 x LLN/ >1.05 x ULN; K: <0.9 x LLN/ >1.1 x ULN; Ca: <0.8 x LLN/>1.2 x ULN
Query!
Timepoint [40]
0
0
Day IP-85 through Day MP-365
Query!
Secondary outcome [41]
0
0
MP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities
Query!
Assessment method [41]
0
0
Low=lower than LLN, High=greater than ULN. LLN/ULN= serum glucose (Glu): <65 mg/dL/ >220 mg/dL; fasting serum Glu: <0.8 x LLN/ >1.5 x ULN; total protein: < 0.9 x LLN/ >1.1 x ULN; albumin:<0.9 x LLN; uric acid: >1.5 x ULN. For Urinalysis (Urine protein, urine Glu, urine blood, leukocyte esterase, Red Blood Cells [RBCs], White Blood Cells [WBCs]): Use =2 when BL value missing or value =4, or when pre-dose=0 or 0.5. Use =3 when pre-dose=1. Use =4 when pre-dose=2 or 3
Query!
Timepoint [41]
0
0
Day IP-85 through Day MP-365
Query!
Secondary outcome [42]
0
0
OL; Number of Participants With Clinical Response Over Time
Query!
Assessment method [42]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. A clinical response is defined as a reduction from baseline in the Mayo score of = 3 points and = 30%, with an accompanying decrease in the rectal bleeding subscore of = 1 point or absolute rectal bleeding subscore of = 1 point.
Query!
Timepoint [42]
0
0
Day OL-1 through Day OL-729
Query!
Secondary outcome [43]
0
0
OL; Number of Participants With Clinical Remission Over Time
Query!
Assessment method [43]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Clinical remission is defined as a Mayo score of = 2 points with no individual subscore exceeding 1 point.
Query!
Timepoint [43]
0
0
Day OL-1 through Day OL-729
Query!
Secondary outcome [44]
0
0
OL; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (=1 Point) During OL
Query!
Assessment method [44]
0
0
The Mayo Scoring system ranges from 0 - 12 points and is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Higher Mayo scores indicate greater severity of disease. Mucosal healing was defined as endoscopic subscore = 1 point
Query!
Timepoint [44]
0
0
Open-Label Period (Day OL-1 through Day OL-729)
Query!
Secondary outcome [45]
0
0
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
Query!
Assessment method [45]
0
0
The Mayo Scoring system (range 0-12 points, high scores=greater severity of disease) is a composite index consisting of 4 disease variables (stool frequency, rectal bleeding, endoscopy evaluation, and Physician's Global Assessment). Clinical response=reduction from baseline in the Mayo score of = 3 points and = 30%, with accompanying decrease in the rectal bleeding subscore of = 1 point or absolute rectal bleeding subscore of = 1 point. Clinical remission = Mayo score of = 2 points with no individual subscore exceeding 1 point. Change from Baseline= post-Baseline - Baseline value.
Query!
Timepoint [45]
0
0
Last Study Visit (Day OL-729)
Query!
Secondary outcome [46]
0
0
OL; Number of Participants With Abatacept-Induced Antibodies
Query!
Assessment method [46]
0
0
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.
Query!
Timepoint [46]
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)
Query!
Secondary outcome [47]
0
0
OL; Number of Participants Using Corticosteroids During OL
Query!
Assessment method [47]
0
0
Participants taking oral corticosteroids (equivalent of = 30 mg prednisone daily) must have met minimum treatment duration at entry into IP and had stable dose for =2 weeks prior to entry into the IP.
Query!
Timepoint [47]
0
0
Day OL-1 through Day OL-729
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2006
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
591
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - Garran
Query!
Recruitment hospital [2]
0
0
Local Institution - Camperdown
Query!
Recruitment hospital [3]
0
0
Local Institution - Herston
Query!
Recruitment hospital [4]
0
0
Local Institution - South Brisbane
Query!
Recruitment hospital [5]
0
0
Local Institution - Bedford Park
Query!
Recruitment hospital [6]
0
0
Local Institution - Launceston
Query!
Recruitment hospital [7]
0
0
Local Institution - Box Hill
Query!
Recruitment hospital [8]
0
0
Local Institution - Fitzroy
Query!
Recruitment hospital [9]
0
0
Local Institution - South Ballarat
Query!
Recruitment hospital [10]
0
0
Local Institution - Fremantle
Query!
Recruitment postcode(s) [1]
0
0
2605 - Garran
Query!
Recruitment postcode(s) [2]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [3]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [4]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [5]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [6]
0
0
7250 - Launceston
Query!
Recruitment postcode(s) [7]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [8]
0
0
3065 VIC - Fitzroy
Query!
Recruitment postcode(s) [9]
0
0
3350 - South Ballarat
Query!
Recruitment postcode(s) [10]
0
0
6160 - Fremantle
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Massachusetts
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Minnesota
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Jersey
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oklahoma
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Pennsylvania
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
South Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Tennessee
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Texas
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Washington
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Bruxelles
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Leuven
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Bahia
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Goias
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Parana
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Rio Grande Do Sul
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Sao Paulo
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Rio De Janeiro
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
British Columbia
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Ontario
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Quebec
Query!
Country [36]
0
0
Czech Republic
Query!
State/province [36]
0
0
Brno - Bohunice
Query!
Country [37]
0
0
Czech Republic
Query!
State/province [37]
0
0
Ceske Budejovice
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Amiens Cedex 1
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Clichy
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Lille Cedex
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Nice
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Paris
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Pessac
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Toulouse
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Kiel
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Muenster
Query!
Country [47]
0
0
India
Query!
State/province [47]
0
0
Andhra Pradesh
Query!
Country [48]
0
0
India
Query!
State/province [48]
0
0
Kerala
Query!
Country [49]
0
0
India
Query!
State/province [49]
0
0
Maharashtra
Query!
Country [50]
0
0
India
Query!
State/province [50]
0
0
Bangalore
Query!
Country [51]
0
0
India
Query!
State/province [51]
0
0
Delhi
Query!
Country [52]
0
0
India
Query!
State/province [52]
0
0
Hyderabad
Query!
Country [53]
0
0
India
Query!
State/province [53]
0
0
Mangalore
Query!
Country [54]
0
0
India
Query!
State/province [54]
0
0
Manipal
Query!
Country [55]
0
0
India
Query!
State/province [55]
0
0
Mumbai
Query!
Country [56]
0
0
India
Query!
State/province [56]
0
0
Mysore
Query!
Country [57]
0
0
Ireland
Query!
State/province [57]
0
0
Dublin
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Napoli
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Padova
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Roma
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
San Giovanni Rotondo
Query!
Country [62]
0
0
Korea, Republic of
Query!
State/province [62]
0
0
Seoul
Query!
Country [63]
0
0
Mexico
Query!
State/province [63]
0
0
Coahuila
Query!
Country [64]
0
0
Mexico
Query!
State/province [64]
0
0
Distrito Federal
Query!
Country [65]
0
0
Mexico
Query!
State/province [65]
0
0
Jalisco
Query!
Country [66]
0
0
Mexico
Query!
State/province [66]
0
0
Nuevo Leon
Query!
Country [67]
0
0
Mexico
Query!
State/province [67]
0
0
Sinaloa
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
Sonora
Query!
Country [69]
0
0
Mexico
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State/province [69]
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Chihuahua
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Country [70]
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Netherlands
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State/province [70]
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Amersfoort
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Country [71]
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Netherlands
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State/province [71]
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Amsterdam
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Country [72]
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Netherlands
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State/province [72]
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Groningen
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Country [73]
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Poland
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State/province [73]
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Katowice
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Country [74]
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Poland
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State/province [74]
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Warszawa
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Poland
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Wroclaw
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Puerto Rico
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Ponce
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Country [77]
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South Africa
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State/province [77]
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Gauteng
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Country [78]
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South Africa
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State/province [78]
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Kwa Zulu Natal
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Country [79]
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South Africa
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State/province [79]
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Western Cape
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Country [80]
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Switzerland
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Bern
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Country [81]
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Switzerland
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State/province [81]
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Zuerich
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Country [82]
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United Kingdom
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State/province [82]
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Greater London
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Country [83]
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United Kingdom
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State/province [83]
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Oxfordshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this clinical research study is to learn if abatacept can improve signs and
symptoms of active ulcerative colitis in patients who have not had an adequate response to
other therapies. The safety of this treatment will also be studied
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00410410
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00410410
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