Trial · NCT02539368
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease
NCT02539368, Completed, Pfizer; results first posted 2020-02-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease. Trials, record NCT02539368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02539368
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease
- NCT number
- NCT02539368
- Status
- Completed
- Enrollment
- 2,565 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn's Disease
- Interventions
- CT-P13, Remicade
- First posted
- 2015-09-03
- Last updated
- 2020-02-13
- Results first posted
- 2020-02-13
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Characteristics of Participants: Disease Duration | Baseline (Day 1) | Disease duration was defined as the number of months from initial diagnosis of inflammatory bowel disease (CD or UC) to the date of informed consent, which was recorded at the time of enrollment into the study (baseline). |
| Primary | Number of Participants Who Switched Treatment | From baseline to follow-up period (up to a maximum duration of 2 years) | Here, number of participants with either UC or CD, who switched from remicade to CT-P13; switched from CT-P13 to remicade and multiple switchers were reported. |
| Primary | Reasons for Switching Treatment by Participants | From baseline to follow-up period (up to a maximum duration of 2 years) | |
| Primary | Total Dose of Infusion Received | From baseline to follow-up period (up to a maximum duration of 2 years) | Total dose of infusion received by the participants was calculated. |
| Primary | Number of Participants by Frequency of Infusion Received | Baseline (Day 1) | Number of participants by infusion frequency (weeks) were reported at baseline and categorized as follows: once a week; once every 2 weeks; once every 3 weeks; once every 4 weeks; once every 5 weeks; once every 6 weeks; once every 7 weeks; once every 8 weeks and others. Here, 'Others' category included all the frequencies apart from the mentioned categories. |
| Primary | Number of Participants Who Had Change in Infusion Dose | From baseline to follow-up period (up to a maximum duration of 2 years) | Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported. |
| Primary | Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change | From baseline to follow-up period (up to a maximum duration of 2 years) | Participants who had change in infusion dose due to various reasons such as principal investigator's decision, participant's decisions, loss of response, lack of compliance, hypersensitivity, occurrence of adverse event (including adverse event special interest \[AESI\]/ serious adverse event \[SAE\]), positive for antibodies and other were reported. Here, 'Others' category included all reasons apart from the mentioned categories. A participant could have different reasons of dose change across visits, hence could be counted in more than one category. |
| Primary | Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC) | From baseline to follow-up period (up to a maximum duration of 2 years) | |
| Primary | Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs) | From baseline to follow-up period (up to a maximum duration of 2 years) | An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to month 24, that were absent before treatment or that worsened relative to pretreatment state. Hypersensitivity was the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events. |
| Secondary | Number of Participants Remaining in Clinical Remission or Relapse | Months 6, 12, 18 and 24 | Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point. Mayo score is an instrument designed to measure disease activity. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician's global assessment, each sub score graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease. The relapse of clinical remission was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Characteristics of Participants: Disease Duration | Baseline (Day 1) | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | months | MEDIAN |
| PRIMARY | Number of Participants Who Switched Treatment | From baseline to follow-up period (up to a maximum duration of 2 years) | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Reasons for Switching Treatment by Participants | From baseline to follow-up period (up to a maximum duration of 2 years) | Reasons for switch were not captured in electronic data capture. Hence, due to change in planned analysis, data was not collected and analyzed. | ||
| PRIMARY | Total Dose of Infusion Received | From baseline to follow-up period (up to a maximum duration of 2 years) | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | milligram | MEDIAN |
| PRIMARY | Number of Participants by Frequency of Infusion Received | Baseline (Day 1) | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Had Change in Infusion Dose | From baseline to follow-up period (up to a maximum duration of 2 years) | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change | From baseline to follow-up period (up to a maximum duration of 2 years) | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC) | From baseline to follow-up period (up to a maximum duration of 2 years) | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs) | From baseline to follow-up period (up to a maximum duration of 2 years) | Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Remaining in Clinical Remission or Relapse | Months 6, 12, 18 and 24 | Full analysis set (FAS)=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to assessment of CD or UC).Number analyzed =participants evaluable at specified time points for each arm. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group1,906
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Characteristics of Participants: Disease Duration | CT-P13 | 63.0 | Full Range 0 to 579 | months | |
| Disease Characteristics of Participants: Disease Duration | Remicade | 112.5 | Full Range 0 to 632 | months | |
| Disease Characteristics of Participants: Disease Duration | Switched From Remicade to CT-P13 | 120.0 | Full Range 2 to 593 | months | |
| Disease Characteristics of Participants: Disease Duration | Switched From CT-P13 to Remicade | 86.0 | Full Range 0 to 519 | months | |
| Disease Characteristics of Participants: Disease Duration | Multiple Switchers | 101.0 | Full Range 9 to 457 | months | |
| Number of Participants Who Switched Treatment | Switched From Remicade to CT-P13 | Crohn's Disease | 237 | Participants | |
| Number of Participants Who Switched Treatment | Switched From CT-P13 to Remicade | Crohn's Disease | 47 | Participants | |
| Number of Participants Who Switched Treatment | Multiple Switchers | Crohn's Disease | 72 | Participants | |
| Number of Participants Who Switched Treatment | Switched From Remicade to CT-P13 | Ulcerative Colitis | 121 | Participants | |
| Number of Participants Who Switched Treatment | Switched From CT-P13 to Remicade | Ulcerative Colitis | 20 | Participants |
1 to 10 of 1,906Source ClinicalTrials.gov
See all 1,906 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CT-P13 | 1,522 | |
| Overall Study | STARTED | Remicade | 494 | |
| Overall Study | STARTED | Switched From Remicade to CT-P13 | 358 | |
| Overall Study | STARTED | Switched From CT-P13 to Remicade | 67 | |
| Overall Study | STARTED | Multiple Switchers | 102 | |
| Overall Study | COMPLETED | CT-P13 | 1,117 | |
| Overall Study | COMPLETED | Remicade | 393 | |
| Overall Study | COMPLETED | Switched From Remicade to CT-P13 | 291 | |
| Overall Study | COMPLETED | Switched From CT-P13 to Remicade | 60 | |
| Overall Study | COMPLETED | Multiple Switchers | 88 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events2,295
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 | CT-P13 | 1 | 1,522 | |
| other | Anaemia | Blood and lymphatic system disorders | Remicade | 4 | 494 | |
| other | Anaemia | Blood and lymphatic system disorders | Switched From Remicade to CT-P13 | 0 | 358 | |
| other | Anaemia | Blood and lymphatic system disorders | Switched From CT-P13 to Remicade | 0 | 67 | |
| other | Anaemia | Blood and lymphatic system disorders | Multiple Switchers | 1 | 102 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | CT-P13 | 1 | 1,522 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Remicade | 0 | 494 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Switched From Remicade to CT-P13 | 0 | 358 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Switched From CT-P13 to Remicade | 0 | 67 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Multiple Switchers | 0 | 102 |
1 to 10 of 2,295Source ClinicalTrials.gov
See all 2,295 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CT-P13 | 4 | 1,522 |
| Total, all-cause mortality | Remicade | 2 | 494 |
| Total, all-cause mortality | Switched From Remicade to CT-P13 | 1 | 358 |
| Total, all-cause mortality | Switched From CT-P13 to Remicade | 0 | 67 |
| Total, all-cause mortality | Multiple Switchers | 0 | 102 |
| Total, other adverse events | CT-P13 | 442 | 1,522 |
| Total, other adverse events | Remicade | 100 | 494 |
| Total, other adverse events | Switched From Remicade to CT-P13 | 90 | 358 |
| Total, other adverse events | Switched From CT-P13 to Remicade | 7 | 67 |
| Total, other adverse events | Multiple Switchers | 21 | 102 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37038897 | DERIVED |
Source PubMed
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02539368
GET https://conductscience.org/api/trials/v1/NCT02539368/registered?page=2