Trial · NCT00488631
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
NCT00488631, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2013-11-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis. Trials, record NCT00488631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00488631
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
- NCT number
- NCT00488631
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,228 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Colitis, Ulcerative
- Interventions
- Placebo, Golimumab 50 mg, Golimumab 100 mg, Golimumab 200 mg
- First posted
- 2007-06-20
- Last updated
- 2016-04-26
- Other registries' IDs
- eudract:2006-003399-37
- Results first posted
- 2013-11-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants in Clinical Response Through Week 54 | Induction Baseline, Week 0 through Week 54 | Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (\>=) 30 percent and \>= 3, with either decrease from induction baseline in rectal bleeding subscore of \>= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12. |
| Secondary | Number of Participants With Clinical Remission at Both Week 30 and Week 54 | Week 30 and Week 54 | 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 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. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported. |
| Secondary | Number of Participants With Mucosal Healing at Both Week 30 and Week 54 | Week 30 and Week 54 | Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported. |
| Secondary | Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study | Week 30 and Week 54 | 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 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. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported. |
| Secondary | Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study | Week 54 | 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 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants in Clinical Response Through Week 54 | Induction Baseline, Week 0 through Week 54 | Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Remission at Both Week 30 and Week 54 | Week 30 and Week 54 | Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Participants | NUMBER |
| SECONDARY | Number of Participants With Mucosal Healing at Both Week 30 and Week 54 | Week 30 and Week 54 | Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study | Week 30 and Week 54 | Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study | Week 54 | Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants in Clinical Response Through Week 54 | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | 48 | Participants | ||
| Number of Participants in Clinical Response Through Week 54 | GLM-I-Rsp-Golimumab 50 mg Maintenance | 71 | Participants | ||
| Number of Participants in Clinical Response Through Week 54 | GLM-I-Rsp-Golimumab 100 mg Maintenance | 75 | Participants | ||
| Number of Participants With Clinical Remission at Both Week 30 and Week 54 | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | 24 | Participants | ||
| Number of Participants With Clinical Remission at Both Week 30 and Week 54 | GLM-I-Rsp-Golimumab 50 mg Maintenance | 35 | Participants | ||
| Number of Participants With Clinical Remission at Both Week 30 and Week 54 | GLM-I-Rsp-Golimumab 100 mg Maintenance | 42 | Participants | ||
| Number of Participants With Mucosal Healing at Both Week 30 and Week 54 | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | 41 | Participants | ||
| Number of Participants With Mucosal Healing at Both Week 30 and Week 54 | GLM-I-Rsp-Golimumab 50 mg Maintenance | 63 | Participants | ||
| Number of Participants With Mucosal Healing at Both Week 30 and Week 54 | GLM-I-Rsp-Golimumab 100 mg Maintenance | 64 | Participants | ||
| Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | 13 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Period (Week 0-54) | STARTED | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | 156 | |
| Double Blind Period (Week 0-54) | STARTED | GLM-I-Rsp-Golimumab 50 mg Maintenance | 154 | |
| Double Blind Period (Week 0-54) | STARTED | GLM-I-Rsp-Golimumab 100 mg Maintenance | 154 | |
| Double Blind Period (Week 0-54) | STARTED | Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance | 129 | |
| Double Blind Period (Week 0-54) | STARTED | PBO-I-nonRsp-Golimumab 100 mg Maintenance | 230 | |
| Double Blind Period (Week 0-54) | STARTED | GLM-I-nonRsp-Golimumab 100 mg Maintenance | 405 | |
| Double Blind Period (Week 0-54) | STARTED | Placebo Extension | 0 | |
| Double Blind Period (Week 0-54) | STARTED | Golimumab 50 mg - Extension | 0 | |
| Double Blind Period (Week 0-54) | STARTED | Golimumab 100 mg Extension | 0 | |
| Double Blind Period (Week 0-54) | STARTED | Golimumab 200 mg Extension | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events5,418
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | 1 | 156 | |
| other | Anaemia | Blood and lymphatic system disorders | GLM-I-Rsp-Golimumab 50 mg Maintenance | 4 | 154 | |
| other | Anaemia | Blood and lymphatic system disorders | GLM-I-Rsp-Golimumab 100 mg Maintenance | 5 | 154 | |
| other | Anaemia | Blood and lymphatic system disorders | GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg | 2 | 76 | |
| other | Anaemia | Blood and lymphatic system disorders | GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg | 1 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg | 0 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance | 2 | 129 | |
| other | Anaemia | Blood and lymphatic system disorders | PBO-I-nonRsp-Golimumab 100 mg Maintenance | 10 | 230 | |
| other | Anaemia | Blood and lymphatic system disorders | GLM-I-nonRsp-Golimumab 100 mg Maintenance | 22 | 405 | |
| other | Anaemia | Blood and lymphatic system disorders | PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg | 1 | 56 |
1 to 10 of 5,418Source ClinicalTrials.gov
See all 5,418 adverse eventsAdverse event totals54
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance | ||
| Total, all-cause mortality | GLM-I-Rsp-Golimumab 50 mg Maintenance | ||
| Total, all-cause mortality | GLM-I-Rsp-Golimumab 100 mg Maintenance | ||
| Total, all-cause mortality | GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg | ||
| Total, all-cause mortality | GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg | ||
| Total, all-cause mortality | GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg | ||
| Total, all-cause mortality | Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance | ||
| Total, all-cause mortality | PBO-I-nonRsp-Golimumab 100 mg Maintenance | ||
| Total, all-cause mortality | GLM-I-nonRsp-Golimumab 100 mg Maintenance | ||
| Total, all-cause mortality | PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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