Phase 3
N=591
A Study of Abatacept in Patients With Active Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT00410410 ↗Enrolled (actual)
591
Serious AEs
13.5%
Results posted
Dec 2010
Primary outcome: Primary: Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) — 30; 26; 14; 41 participants — p=0.124
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- abatacept (ABA) (Drug); placebo (Drug); abatacept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) |
30; 26; 14; 41 | 0.124 |
| PRIMARY Maintenance Period (MP); Number of Participants With Clinical Response (Per Mayo Score) at Month 12 |
11; 11 | — |
| PRIMARY 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 |
241; 100; 1; 66; 9; 7 | — |
| PRIMARY OL; Number of Participants With AEs of Special Interest |
127; 9; 2; 1; 1; 5 | — |
| PRIMARY OL; Number of Participants With Physical Examination Findings |
— | — |
| PRIMARY OL; Number of Participants With Marked Hematology Laboratory Abnormalities |
20; 17; 6; 3; 3; 18 | — |
| PRIMARY OL; Number of Participants With Liver and Kidney Function and Electrolyte Laboratory Abnormalities |
4; 3; 3; 17; 1; 10 | — |
| PRIMARY OL; Number of Participants With Chemistry and Urinalysis Laboratory Abnormalities |
4; 6; 3; 12; 11; 4 | — |
| SECONDARY IP; Baseline Mayo Score: IP1C |
8.9; 8.8; 8.6; 8.8 | — |
| SECONDARY IP; Number of Participants in Clinical Remission (Per Mayo Score) at Week 12: IP1C |
3; 6; 4; 15 | — |
| SECONDARY IP; Number of Participants in Mucosal Healing (Per Mayo Score) at Week 12: IP1C |
24; 20; 11; 36 | — |
| SECONDARY IP; Number of Participants With Clinical Response (Per Mayo Score) at Week 12 Analyzed by Cochran-Armitage Trend Test for Dose-Response Relationship: IP1C |
41; 14; 26; 30 | 0.044 sig |
| SECONDARY IP; Baseline Inflammatory Bowel Disease Questionnaire (IBDQ) Score: IP1C |
120.0; 121.5; 126.9; 124.3 | — |
| SECONDARY IP; Mean Change From Baseline To Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ): IP1C |
9.45; 13.36; 9.87; 23.68 | — |
| SECONDARY IP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C |
28; 36; 16; 47; 31; 30 | — |
| SECONDARY IP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C |
13; 8; 4; 14; 14; 21 | — |
| SECONDARY IP; Number of Participants With Mayo Physician Global Assessment (PGA) Subscores Indicating Mild Disease (≤1 Point) at Week 12: IP1C |
2; 4; 3; 11; 22; 25 | — |
| SECONDARY 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 |
12; 4; 7; 8 | 0.149 |
| SECONDARY IP; Number of Participants With Clinical Response At Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C |
8; 7; 4; 12 | — |
| SECONDARY IP; Number of Participants in Clinical Remission at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C |
2; 0; 0; 4 | — |
| SECONDARY IP; Number of Participants in Mucosal Healing at Week 12 Among Participants With Anti-TNF (Infliximab) Failure/Intolerance: IP1C |
4; 4; 1; 13 | — |
| SECONDARY IP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation: IP1C + IP2C |
85; 92; 39; 86; 26; 27 | — |
| SECONDARY IP; Number of Participants With AEs Of Special Interest: IP1C + IP2C |
23; 29; 8; 25; 12; 7 | — |
| SECONDARY IP; Number of Participants With Physical Examination Findings: IP1C + IP2C |
— | — |
| SECONDARY IP; Number of Participants With Marked Hematology Laboratory Abnormalities: IP1C |
3; 2; 6; 1; 1; 2 | — |
| SECONDARY IP; Number of Participants With Marked Liver and Kidney Function and Electrolyte Laboratory Abnormalities: IP1C |
1; 0; 0; 0; 0; 1 | — |
| SECONDARY IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP1C |
1; 6; 2; 0; 0; 0 | — |
| SECONDARY IP; Number of Participants With Marked Hematology, Liver and Kidney Function, and Electrolyte Laboratory Abnormalities: IP2C |
2; 2; 1; 0; 1; 0 | — |
| SECONDARY IP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities: IP2C |
0; 2; 0; 2; 2; 0 | — |
| SECONDARY IP; Number of Participants With Abatacept-Induced Antibodies: IP1C + IP2C |
6; 19; 4; 2; 17; 4 | — |
| SECONDARY MP; Number of Participants in Clinical Remission at Month 12 |
8; 9 | — |
| SECONDARY MP; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) at Month 12 |
11; 10 | — |
| SECONDARY MP; Number of Participants in Clinical Remission at Both Month 6 and Month 12 |
— | — |
| SECONDARY MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids and Achieved Clinical Remission by Month 12 |
— | — |
| SECONDARY MP; Mean Change From Baseline to Month 12 in IBDQ |
— | — |
| SECONDARY MP; Mean Change From Baseline to Month 12 in Short Form-36 (SF-36) |
— | — |
| SECONDARY MP; Number of Participants With Baseline Oral Corticosteroid Use Who Have Discontinued Corticosteroids for 90 Consecutive Days and Achieved Clinical Remission by Month 12 |
— | — |
| SECONDARY MP; Number of Participants With Mayo Rectal Bleeding Subscores Indicating Mild Disease (≤1 Point) at Month 12 |
— | — |
| SECONDARY MP; Number of Participants With Mayo Stool Frequency Subscores Indicating Mild Disease (≤1 Point) at Month 12 |
— | — |
| SECONDARY MP; Number of Participants With Mayo PGA Subscores Indicating Mild Disease (≤1 Point) at Month 12 |
— | — |
| SECONDARY MP; Number of Participants With Clinical Response at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) |
— | — |
| SECONDARY MP; Number of Participants With Clinical Remission at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) |
— | — |
| SECONDARY MP; Number of Participants With Clinical Mucosal Healing at Month 12 Among Participants With Inadequate Response/Intolerance to Prior Anti-TNF Therapy (Infliximab) |
— | — |
| SECONDARY MP; Number of Participants With Abatacept-Induced Antibodies |
8; 20; 8; 17; 0; 3 | — |
| SECONDARY MP; Number of Participants With Adverse Events (AEs), Related AEs, Deaths, Serious AEs (SAEs), Related SAEs, and AEs Leading to Discontinuation |
39; 36; 12; 13; 1; 0 | — |
| SECONDARY MP; Number of Participants With AEs of Special Interest |
39; 36; 5; 2; 1; 0 | — |
| SECONDARY MP; Number of Participants With Physical Examination Findings |
— | — |
| SECONDARY MP; Number of Participants With Marked Hematology Laboratory Abnormalities |
1; 2; 3; 2; 1; 2 | — |
| SECONDARY MP; Number of Participants With Marked Chemistry and Urinalysis Laboratory Abnormalities |
0; 2; 3; 3; 0; 1 | — |
| SECONDARY OL; Number of Participants With Clinical Response Over Time |
44; 0 | — |
| SECONDARY OL; Number of Participants With Clinical Remission Over Time |
18; 0 | — |
| SECONDARY OL; Number of Participants With Mayo Endoscopic Subscores Indicating Mucosal Healing (≤1 Point) During OL |
0; 0 | — |
| SECONDARY 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 |
— | — |
| SECONDARY OL; Number of Participants With Abatacept-Induced Antibodies |
66; 59; 11 | — |
| SECONDARY OL; Number of Participants Using Corticosteroids During OL |
— | — |
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
Eligibility Criteria
Inclusion Criteria
- Men or women 18 years or older
- Ulcerative colitis for at lease 3 months
- Moderate to severe active ulcerative colitis
- Inadequate response or intolerance to standard ulcerative colitis treatment
Data sourced from ClinicalTrials.gov (NCT00410410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.