Trial Outcomes & Findings for An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis (NCT NCT00488774)
NCT ID: NCT00488774
Last Updated: 2013-06-14
Results Overview
Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
291 participants
Primary outcome timeframe
Week 6
Results posted on
2013-06-14
Participant Flow
Participant milestones
| Measure |
Placebo
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
|
Golimumab 1 Milligram (mg) Per Kilogram (kg)
Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
|
Golimumab 2 mg Per kg
Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 4 mg Per kg
Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
77
|
62
|
75
|
77
|
|
Overall Study
COMPLETED
|
69
|
57
|
70
|
74
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
5
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
|
Golimumab 1 Milligram (mg) Per Kilogram (kg)
Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
|
Golimumab 2 mg Per kg
Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 4 mg Per kg
Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal of consent
|
2
|
2
|
2
|
0
|
|
Overall Study
Other
|
6
|
3
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
Baseline Characteristics
An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Placebo
n=77 Participants
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
|
Golimumab 1 mg Per kg
n=62 Participants
Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
|
Golimumab 2 mg Per kg
n=75 Participants
Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 4 mg Per kg
n=77 Participants
Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
|
Total
n=291 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
40.9 Years
STANDARD_DEVIATION 12.58 • n=5 Participants
|
40.7 Years
STANDARD_DEVIATION 15.51 • n=7 Participants
|
42.3 Years
STANDARD_DEVIATION 13.14 • n=5 Participants
|
39.9 Years
STANDARD_DEVIATION 14.07 • n=4 Participants
|
41 Years
STANDARD_DEVIATION 13.74 • n=21 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here 'N' signifies participants who were evaluated for this outcome measure.
Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Outcome measures
| Measure |
Placebo
n=73 Participants
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
|
Golimumab 1 mg Per kg
n=61 Participants
Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 2 mg Per kg
n=75 Participants
Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 4 mg Per kg
n=77 Participants
Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Response
|
22 Participants
|
22 Participants
|
33 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Week 6Population: The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here 'N' signifies participants who were evaluated for this outcome measure.
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Outcome measures
| Measure |
Placebo
n=73 Participants
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
|
Golimumab 1 mg Per kg
n=61 Participants
Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 2 mg Per kg
n=75 Participants
Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 4 mg Per kg
n=77 Participants
Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Remission
|
8 Participants
|
6 Participants
|
12 Participants
|
10 Participants
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Golimumab 1 mg Per kg
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Golimumab 2 mg Per kg
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Golimumab 4 mg Per kg
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=77 participants at risk
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
|
Golimumab 1 mg Per kg
n=63 participants at risk
Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 2 mg Per kg
n=74 participants at risk
Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 4 mg Per kg
n=76 participants at risk
Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Colitis ulcerative
|
1.3%
1/77 • Baseline up to Week 16
|
3.2%
2/63 • Baseline up to Week 16
|
2.7%
2/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
1.4%
1/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Subileus
|
1.3%
1/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Infections and infestations
Cellulitis
|
0.00%
0/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
1.3%
1/76 • Baseline up to Week 16
|
|
Infections and infestations
Sepsis
|
0.00%
0/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
1.3%
1/76 • Baseline up to Week 16
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
1.3%
1/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
1.3%
1/76 • Baseline up to Week 16
|
Other adverse events
| Measure |
Placebo
n=77 participants at risk
Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
|
Golimumab 1 mg Per kg
n=63 participants at risk
Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 2 mg Per kg
n=74 participants at risk
Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
|
Golimumab 4 mg Per kg
n=76 participants at risk
Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/77 • Baseline up to Week 16
|
1.6%
1/63 • Baseline up to Week 16
|
2.7%
2/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/77 • Baseline up to Week 16
|
3.2%
2/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
1.3%
1/76 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Colitis ulcerative
|
2.6%
2/77 • Baseline up to Week 16
|
3.2%
2/63 • Baseline up to Week 16
|
4.1%
3/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Nausea
|
2.6%
2/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
1.4%
1/74 • Baseline up to Week 16
|
2.6%
2/76 • Baseline up to Week 16
|
|
General disorders
Fatigue
|
2.6%
2/77 • Baseline up to Week 16
|
1.6%
1/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
General disorders
Pyrexia
|
0.00%
0/77 • Baseline up to Week 16
|
1.6%
1/63 • Baseline up to Week 16
|
2.7%
2/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
1/77 • Baseline up to Week 16
|
1.6%
1/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
2.6%
2/76 • Baseline up to Week 16
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/77 • Baseline up to Week 16
|
1.6%
1/63 • Baseline up to Week 16
|
4.1%
3/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
1/77 • Baseline up to Week 16
|
3.2%
2/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
1.3%
1/76 • Baseline up to Week 16
|
|
Investigations
Haematocrit decreased
|
2.6%
2/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Investigations
Haemoglobin decreased
|
2.6%
2/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Nervous system disorders
Headache
|
1.3%
1/77 • Baseline up to Week 16
|
1.6%
1/63 • Baseline up to Week 16
|
4.1%
3/74 • Baseline up to Week 16
|
2.6%
2/76 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/77 • Baseline up to Week 16
|
3.2%
2/63 • Baseline up to Week 16
|
4.1%
3/74 • Baseline up to Week 16
|
1.3%
1/76 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/77 • Baseline up to Week 16
|
0.00%
0/63 • Baseline up to Week 16
|
2.7%
2/74 • Baseline up to Week 16
|
1.3%
1/76 • Baseline up to Week 16
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/77 • Baseline up to Week 16
|
3.2%
2/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
0.00%
0/76 • Baseline up to Week 16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
4/77 • Baseline up to Week 16
|
1.6%
1/63 • Baseline up to Week 16
|
0.00%
0/74 • Baseline up to Week 16
|
1.3%
1/76 • Baseline up to Week 16
|
Additional Information
Senior Director
Janssen Research & Development
Phone: 215-793-7540
Results disclosure agreements
- Principal investigator is a sponsor employee Twelve months after study ends, Sponsor will be provided with a copy of materials at least 45 days prior to submission, with details of proposed date, journal or conference name of publication \& it will have 30 days post receipt to send written request that publication be delayed on the basis it exposes intellectual property that requires propriety protection but it will be only for 60 days after which Investigator will be free to publish. The participation of Sponsor will be acknowledged.
- Publication restrictions are in place
Restriction type: OTHER