Trial Outcomes & Findings for Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis (NCT NCT03018925)
NCT ID: NCT03018925
Last Updated: 2021-07-19
Results Overview
Shifts of abundance of Eubacteria (EUB), A. municiphila (AKK), M. smithii (MSM), Bacteroidetes (BAC), Ruminococcus sp. (RUM), F. prausnitzii (FPRA) and E. coli (ECO) levels will be measured prior (week 0) and progressively all through golimumab therapy until week 54. Results will be expressed as 16S gene copies of microbes per gram of faeces.
Recruitment status
COMPLETED
Target enrollment
15 participants
Primary outcome timeframe
Baseline (week 0); week 4; week 9; week 13; week 26; week 39; week 52
Results posted on
2021-07-19
Participant Flow
Participant milestones
| Measure |
Ulcerative Colitis
A total of 15 patients were included in the study. Stool samples were collected before starting anti-TNFα treatment (A), 4 weeks (B), 2 months after (C), 3 months (D), 6 months (E), 9 months (F) and finally 1 year after starting treatment (G). The monitoring period was one year long.
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
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|---|---|
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Overall Study
STARTED
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15
|
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Ulcerative Colitis
n=105 faeces
The proposed study will include 15 UC anti-TNF naïve patients . We will consider remission when patients have an endoscopic Mayo score ≤1, and activity index score, Mayo= 0 points.
Stool samples will be collected before starting Anti-TNF treatment (M0), and then every 3 months (M1, M2, M3 and M4) to complete the study.
GOLIMUMAB induction with 200mg at week 0, and 100mg at week 2. Under 70kg, the follow up treatment will be 50mg/month, and 100mg/month in patients over 70kg, as clinical practice.
Golimumab
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|---|---|
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Age, Continuous
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42 years
n=15 Participants
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Sex: Female, Male
Female
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8 Participants
n=15 Participants
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Sex: Female, Male
Male
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7 Participants
n=15 Participants
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Abundance
Total abundance of EUB 16S gene copies per gram of faeces
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44895329 16S gene copies per gram of faeces
STANDARD_DEVIATION 60712475 • n=105 faeces
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Abundance
Total abundance of FPRA 16S gene copies per gram of faeces
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632588897 16S gene copies per gram of faeces
STANDARD_DEVIATION 973329718 • n=105 faeces
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Abundance
Total abundance of ECO 16S gene copies per gram of faeces
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13920879614 16S gene copies per gram of faeces
STANDARD_DEVIATION 23430581289 • n=105 faeces
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Abundance
Total abundance of PHG-I 16S gene copies per gram of faeces
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5595001683 16S gene copies per gram of faeces
STANDARD_DEVIATION 15764400311 • n=105 faeces
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Abundance
Total abundance of PHG-II 16S gene copies per gram of faeces
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13444198425 16S gene copies per gram of faeces
STANDARD_DEVIATION 45637222044 • n=105 faeces
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Abundance
Total abundance of AKK 16S gene copies per gram of faeces
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1137084734 16S gene copies per gram of faeces
STANDARD_DEVIATION 983517092 • n=105 faeces
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Abundance
Total abundance of BAC 16S gene copies per gram of faeces
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72930687 16S gene copies per gram of faeces
STANDARD_DEVIATION 119110706 • n=105 faeces
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Abundance
Total abundance of RUM 16S gene copies per gram of faeces
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266628585 16S gene copies per gram of faeces
STANDARD_DEVIATION 670089788 • n=105 faeces
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Abundance
Total abundance of MSM 16S gene copies per gram of faeces
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1694557243 16S gene copies per gram of faeces
STANDARD_DEVIATION 2573008595 • n=105 faeces
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faecal calprotectin
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959.52 microgram calprotectin per gram faeces
STANDARD_DEVIATION 781.41 • n=105 faeces
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PRIMARY outcome
Timeframe: Baseline (week 0); week 4; week 9; week 13; week 26; week 39; week 52Shifts of abundance of Eubacteria (EUB), A. municiphila (AKK), M. smithii (MSM), Bacteroidetes (BAC), Ruminococcus sp. (RUM), F. prausnitzii (FPRA) and E. coli (ECO) levels will be measured prior (week 0) and progressively all through golimumab therapy until week 54. Results will be expressed as 16S gene copies of microbes per gram of faeces.
Outcome measures
| Measure |
Ulcerative Colitis Baseline
n=15 Participants
A total of 15 patients were included in the study. Stool samples were collected before starting anti-TNFα treatment (A).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 4
n=15 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 4 after treatment (B).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 9
n=15 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 9 after (C) starting treatment.
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 13
n=15 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 13 after starting treatment (D).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 26
n=15 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 24 after starting treatment (E).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
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Ulcerative Colitis Week 39
n=15 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 39 after starting treatment (F).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 52
n=15 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 52 after starting treatment.
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
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|---|---|---|---|---|---|---|---|
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Golimumab Induced Shifts in the Abundance of Bacterial Markers
16S PHG-1 gene copies/gr
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1554167134258 16S gene copies per gram of faeces
Standard Deviation 4379000086392
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2287342976506 16S gene copies per gram of faeces
Standard Deviation 5800677622879
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1443246127037 16S gene copies per gram of faeces
Standard Deviation 4465319951431
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1454728431339 16S gene copies per gram of faeces
Standard Deviation 4462926477230
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1486551880693 16S gene copies per gram of faeces
Standard Deviation 4369653984051
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1484947845315 16S gene copies per gram of faeces
Standard Deviation 4370115404158
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2264764764378 16S gene copies per gram of faeces
Standard Deviation 5588585629983
|
|
Golimumab Induced Shifts in the Abundance of Bacterial Markers
16S PHG-2 gene copiese/gr
|
3734499562508 16S gene copies per gram of faeces
Standard Deviation 12677006123368
|
4224010739381 16S gene copies per gram of faeces
Standard Deviation 15618887473109
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2856262666851 16S gene copies per gram of faeces
Standard Deviation 11831601059514
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2850757893262 16S gene copies per gram of faeces
Standard Deviation 11832638079600
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3374769646848 16S gene copies per gram of faeces
Standard Deviation 12473113644843
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3377322959435 16S gene copies per gram of faeces
Standard Deviation 12472534823110
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4956971378048 16S gene copies per gram of faeces
Standard Deviation 16148476082404
|
|
Golimumab Induced Shifts in the Abundance of Bacterial Markers
16S MSM gene copies/gr
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1412131035956 16S gene copies per gram of faeces
Standard Deviation 2144173829971
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1448338957715 16S gene copies per gram of faeces
Standard Deviation 103802651252363
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1154472147552 16S gene copies per gram of faeces
Standard Deviation 2014237593970
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1324144197647 16S gene copies per gram of faeces
Standard Deviation 2030070772991
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1419822238221 16S gene copies per gram of faeces
Standard Deviation 2125371379113
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1378914738249 16S gene copies per gram of faeces
Standard Deviation 2079724959914
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1354846963287 16S gene copies per gram of faeces
Standard Deviation 2528371614749
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Golimumab Induced Shifts in the Abundance of Bacterial Markers
16S EUB gene copies/gr
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14965109899 16S gene copies per gram of faeces
Standard Deviation 20237491739
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132857054401767 16S gene copies per gram of faeces
Standard Deviation 113260468624418
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12779328208 16S gene copies per gram of faeces
Standard Deviation 9068076455
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12851286145 16S gene copies per gram of faeces
Standard Deviation 9017866924
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12454690659 16S gene copies per gram of faeces
Standard Deviation 12454690659854
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12503490379 16S gene copies per gram of faeces
Standard Deviation 8532885467
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12813434576 16S gene copies per gram of faeces
Standard Deviation 10526337966
|
|
Golimumab Induced Shifts in the Abundance of Bacterial Markers
16S FPRA gene copies/gr
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175719138207 16S gene copies per gram of faeces
Standard Deviation 270369366223
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170223467854756 16S gene copies per gram of faeces
Standard Deviation 236215626215223
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155540451664 16S gene copies per gram of faeces
Standard Deviation 189790530774
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156132981396 16S gene copies per gram of faeces
Standard Deviation 89588898844
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147240545450 16S gene copies per gram of faeces
Standard Deviation 178731186533
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147465572493 16S gene copies per gram of faeces
Standard Deviation 178661245731
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147013558563 16S gene copies per gram of faeces
Standard Deviation 220645931988
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|
Golimumab Induced Shifts in the Abundance of Bacterial Markers
16S ECO gene copies/gr
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3314495146263 16S gene copies per gram of faeces
Standard Deviation 5578709830918
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3181151220276 16S gene copies per gram of faeces
Standard Deviation 3126128990251
|
2987333503143 16S gene copies per gram of faeces
Standard Deviation 3353864671731
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2953273068761 16S gene copies per gram of faeces
Standard Deviation 3369672897008
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2670971592149 16S gene copies per gram of faeces
Standard Deviation 3245749806014
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2676569979573 16S gene copies per gram of faeces
Standard Deviation 3242227933303
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2862128876536 16S gene copies per gram of faeces
Standard Deviation 3694099594126
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Golimumab Induced Shifts in the Abundance of Bacterial Markers
16S AKK gene copies/gr
|
631713741289 16S gene copies per gram of faeces
Standard Deviation 546398384696
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676730972613383 16S gene copies per gram of faeces
Standard Deviation 619061596613631
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648849626045 16S gene copies per gram of faeces
Standard Deviation 560073798388
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656752409224 16S gene copies per gram of faeces
Standard Deviation 555980667881
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631530294495 16S gene copies per gram of faeces
Standard Deviation 541410081002
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624464830535 16S gene copies per gram of faeces
Standard Deviation 541709460521
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588975881273 16S gene copies per gram of faeces
Standard Deviation 573284067068
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|
Golimumab Induced Shifts in the Abundance of Bacterial Markers
16S RUM gene copies/gr
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177752390157 16S gene copies per gram of faeces
Standard Deviation 446726525618
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875769282253977 16S gene copies per gram of faeces
Standard Deviation 107172042366984
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94665231220 16S gene copies per gram of faeces
Standard Deviation 103802651252
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89460668888 16S gene copies per gram of faeces
Standard Deviation 98352969991
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175237205610 16S gene copies per gram of faeces
Standard Deviation 443046731406
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140434420342 16S gene copies per gram of faeces
Standard Deviation 366893347216
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183217036465 16S gene copies per gram of faeces
Standard Deviation 470624954343
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Golimumab Induced Shifts in the Abundance of Bacterial Markers
16S BAC gene copies/gr
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24310229086 16S gene copies per gram of faeces
Standard Deviation 39703568898
|
1154472147552 16S gene copies per gram of faeces
Standard Deviation 2014237593970
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25492065263 16S gene copies per gram of faeces
Standard Deviation 41712078985
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25406506889 16S gene copies per gram of faeces
Standard Deviation 41440365839
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24041089844 16S gene copies per gram of faeces
Standard Deviation 39392492447
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24145355533 16S gene copies per gram of faeces
Standard Deviation 39357796954
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26282792708 16S gene copies per gram of faeces
Standard Deviation 45453286920
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SECONDARY outcome
Timeframe: Baseline (week 0); week 4; week 9; week 13; week 26; week 39; week 52Shifts on calprotectin levels will be measured prior (week 0) and progressively all through golimumab therapy until week 52. Results will be expressed as microgram of calprotectin per gram of faeces
Outcome measures
| Measure |
Ulcerative Colitis Baseline
n=9 Participants
A total of 15 patients were included in the study. Stool samples were collected before starting anti-TNFα treatment (A).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 4
n=9 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 4 after treatment (B).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 9
n=9 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 9 after (C) starting treatment.
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 13
n=9 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 13 after starting treatment (D).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 26
n=9 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 24 after starting treatment (E).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 39
n=9 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 39 after starting treatment (F).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 52
n=9 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 52 after starting treatment.
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
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|---|---|---|---|---|---|---|---|
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Golimumab Induced Shifts in Calprotectin Faecal Sample Levels
|
1379.78 mg/g
Standard Deviation 761.52
|
626.79 mg/g
Standard Deviation 800.30
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1267.50 mg/g
Standard Deviation 811.18
|
1036.68 mg/g
Standard Deviation 883.24
|
994.39 mg/g
Standard Deviation 714.60
|
545.64 mg/g
Standard Deviation 635.46
|
478.50 mg/g
Standard Deviation 881.02
|
SECONDARY outcome
Timeframe: Baseline (week 0) and week 52Population: Baseline (week 0) and week 52
Change from baseline (week 0) in the Partial Mayo score at week 52 of Golimumab treatment. The clinical Mayo Score or partial Mayo Score (PMS) uses the three non-invasive components of the full Mayo Score (stool frequency, rectal bleeding and physician's global assessement), and thus excluding the endoscopic findings scoring. Maximum score values range from 0 to 9 \[Schroeder et al 2005 NEJM; Rutgeerts et al 2005 NEJM\]. Calculations are based on the sum of scores for the three parameters. Values ranging: \<2, disease in clinical remission; 2-4, mild activity; 5-7, moderate activity; and \>7 severe activity.
Outcome measures
| Measure |
Ulcerative Colitis Baseline
n=15 Participants
A total of 15 patients were included in the study. Stool samples were collected before starting anti-TNFα treatment (A).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 4
n=15 Participants
A total of 15 patients were included in the study. Stool samples were collected at week 4 after treatment (B).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 9
A total of 15 patients were included in the study. Stool samples were collected at week 9 after (C) starting treatment.
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 13
A total of 15 patients were included in the study. Stool samples were collected at week 13 after starting treatment (D).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 26
A total of 15 patients were included in the study. Stool samples were collected at week 24 after starting treatment (E).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 39
A total of 15 patients were included in the study. Stool samples were collected at week 39 after starting treatment (F).
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
Ulcerative Colitis Week 52
A total of 15 patients were included in the study. Stool samples were collected at week 52 after starting treatment.
Patients were classified as responders (responders), responder after dose optimization of anti-TNF treatment (respond after dose optimization) and non-responders (non-responders). Two different statistical analyses were done: one considering the group of responders, responder after dose optimization and non-responders, and another statistical analysis considering a unique group of responder and responders after dose optimization versus non-responders.
Due to the fact that there are only 2 non-responders and a minimum number of 3 individuals (n= 3) is required to perform statistics, these 2 samples have been doubled for analysis.
|
|---|---|---|---|---|---|---|---|
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Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 3
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2 score on a scale
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0 score on a scale
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—
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—
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—
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—
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—
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Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 4
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0 score on a scale
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0 score on a scale
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—
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—
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—
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—
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—
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Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 1
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2 score on a scale
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0 score on a scale
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—
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—
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—
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—
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—
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|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 2
|
9 score on a scale
|
5 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 5
|
3 score on a scale
|
0 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 6
|
6 score on a scale
|
0 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 7
|
5 score on a scale
|
2 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 8
|
7 score on a scale
|
0 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 9
|
8 score on a scale
|
0 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 10
|
2 score on a scale
|
1 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 11
|
3 score on a scale
|
0 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 12
|
2 score on a scale
|
5 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 13
|
3 score on a scale
|
0 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 14
|
3 score on a scale
|
1 score on a scale
|
—
|
—
|
—
|
—
|
—
|
|
Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score
Patient 15
|
4 score on a scale
|
1 score on a scale
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Ulcerative Colitis Baseline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ulcerative Colitis Week 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ulcerative Colitis Week 9
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ulcerative Colitis Week 13
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ulcerative Colitis Week 26
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ulcerative Colitis Week 39
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ulcerative Colitis Week 52
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
MD PhD X Aldeguer
Institut d'Investigació Biomèdica de Girona - Hosp Univ Dr Josep Trueta
Phone: 34972940200
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place