Trial · NCT00844285
SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry
NCT00844285, Completed, UCB BIOSCIENCES, Inc.; results first posted 2023-05-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry. Trials, record NCT00844285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00844285
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry
- NCT number
- NCT00844285
- Status
- Completed
- Enrollment
- 3,072 participants, actual
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Conditions
- Crohn's Disease
- Interventions
- Cimzia
- First posted
- 2009-02-16
- Last updated
- 2023-05-06
- Results first posted
- 2023-05-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) | Baseline up to 10 years | Incidence rate is defined as the number of participants experiencing the event of interest divided by the number person-years without an event (time up to the event for participants experiencing an event, and the full study time for those without). Adverse events of interest included malignant or unspecified tumor, serious infections, opportunistic infections, serious cardiovascular events, congestive heart failure, demyelinating-like disorders, aplastic anemia, pancytopenia, thrombocytopenia, neutropenia, leucopenia, serious bleeding events, lupus and lupus-like illness, serious skin reactions, hepatic events, hypersensitivity reactions and anaphylactic reactions, malignant lymphomas, non-melanoma skin cancer, autoimmune disorders. Treatment groups are based upon actual treatment conservatively assigning participant time and events to CZP even after stopping CZP. Data for malignant or unspecified tumor as per malignancy rules has been reported in this outcome measure. |
| Primary | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Baseline up to 10 years | Incidence rate is defined as the number of participants experiencing the event of interest divided by the number person-years without an event (time up to the event for participants experiencing an event, and the full study time for those without an event of interest). Adverse events of interest (AEoI) included malignant or unspecified tumor, serious infections, opportunistic infections, serious cardiovascular events, congestive heart failure, demyelinating-like disorders, aplastic anemia, pancytopenia, thrombocytopenia, neutropenia, leucopenia, serious bleeding events, lupus and lupus-like illness, serious skin reactions, hepatic events, hypersensitivity reactions and anaphylactic reactions, malignant lymphomas, non-melanoma skin cancer, autoimmune disorders. Data for AEoIs as per acute event rules has been reported in this outcome measure where the AEoI is assigned to the treatment the participant is on at the time of the event. |
| Secondary | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline | HBI measured 5 parameters: the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications \[1 per item: joint pain (arthralgia), eye inflammation (uveitis), red nodules on skin (erythema nodosum), canker sores (aphthous ulcers), skin wound/ulcers (pyoderma gangrenosum), tear in skin of anal area (anal fissure), fluid or pus drainage from anal area (new fistula), and abscess\]. The total HBI score was sum of all the 5 individual parameters, where minimum score was 0 and there was no pre-specified maximum score as it was dependent on the number of liquids stools. Higher HBI scores indicated greater disease activity. A negative change indicated less disease activity. |
| Secondary | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105 and 108, compared to Baseline | HBI response determined based on patient reported HBI total scores was defined as a drop of at least 3 points from baseline HBI total score. Patient reported HBI was composed of 4 parameters: the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), and whether there are any complications \[1 per item: joint pain (arthralgia), eye inflammation (uveitis), red nodules on skin (erythema nodosum), canker sores (aphthous ulcers), skin wound/ulcers (pyoderma gangrenosum), tear in skin of anal area (anal fissure), fluid or pus drainage from anal area (new fistula), and abscess\]. The total HBI score was sum of all the 4 individual parameters, where minimum score was 0 and there was no pre-specified maximum score as it was dependent on the number of liquids stools. Higher HBI scores indicated greater disease activity. A negative change indicated less disease activity. |
| Secondary | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline | Physician assessment of disease severity was measured by the general well-being component of HBI score and had a score range of 0= very well to 4= terrible. Higher scores indicated greater disease activity. A negative change indicated less disease activity. |
| Secondary | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105 and 108, compared to Baseline | Patient assessment of disease severity was measured by the general well-being component of HBI score and had a score range of 0= very well to 4= terrible. Higher scores indicated greater disease activity. A negative change indicated less disease activity. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) | Baseline up to 10 years | Enrolled set was defined as all participants enrolled and with an informed consent. Here, Number of Participants Analyzed included those who were evaluable for this outcome measure. Participants were counted in more than one arm based on the various treatments they actually received and presented. Based upon planned analysis, data is reported for Cimzia® and Comparator reporting groups only. | no. of events per 100 participant-years | NUMBER |
| PRIMARY | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Baseline up to 10 years | Enrolled set was defined as all participants enrolled and with an informed consent. Here, Number of Participants Analyzed included those who were evaluable for this outcome measure. Participants were counted in more than one arm based on the various treatments they actually received and presented. Based upon planned analysis, data is reported for Cimzia®, Comparator, Overlap, Gap and Cimzia®+Overlap reporting groups only. | no. of events per 100 participant-years | NUMBER |
| SECONDARY | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline | Enrolled Set was defined as all participants enrolled and with an informed consent. Here, Number Analyzed included those who were evaluable at specified time points only. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105 and 108, compared to Baseline | Enrolled Set was defined as all participants enrolled and with an informed consent. Here, Number Analyzed included those who were evaluable at specified time points only. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline | Enrolled Set was defined as all participants enrolled and with an informed consent. Here, Number Analyzed included those who were evaluable at specified time points only. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105 and 108, compared to Baseline | Enrolled Set was defined as all participants enrolled and with an informed consent. Here, Number Analyzed included those who were evaluable at specified time points only. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group401
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) | Cimzia | 0.45 | 95% Confidence Interval 0.31 to 0.65 | no. of events per 100 participant-years | |
| Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) | Comparator | 0.65 | 95% Confidence Interval 0.48 to 0.86 | no. of events per 100 participant-years | |
| Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Cimzia | Malignant or Unspecified Tumor | 0.35 | 95% Confidence Interval 0.12 to 0.83 | no. of events per 100 participant-years |
| Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Comparator | Malignant or Unspecified Tumor | 0.59 | 95% Confidence Interval 0.44 to 0.77 | no. of events per 100 participant-years |
| Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Overlap | Malignant or Unspecified Tumor | 0.60 | 95% Confidence Interval 0.28 to 1.15 | no. of events per 100 participant-years |
| Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Gap (No Cimzia and no Comparator at Baseline) | Malignant or Unspecified Tumor | 0.56 | 95% Confidence Interval 0.29 to 0.97 | no. of events per 100 participant-years |
| Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Cimzia + Overlap | Malignant or Unspecified Tumor | 0.48 | 95% Confidence Interval 0.26 to 0.81 | no. of events per 100 participant-years |
| Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Cimzia | Serious infections | 2.03 | 95% Confidence Interval 1.35 to 2.94 | no. of events per 100 participant-years |
| Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Comparator | Serious infections | 1.59 | 95% Confidence Interval 1.34 to 1.88 | no. of events per 100 participant-years |
| Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Overlap | Serious infections | 6.15 | 95% Confidence Interval 4.90 to 7.61 | no. of events per 100 participant-years |
1 to 10 of 401Source ClinicalTrials.gov
See all 401 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cimzia at Baseline | 1,131 | |
| Overall Study | STARTED | No Cimzia at Baseline | 1,666 | |
| Overall Study | STARTED | Gap (No Cimzia and no Comparator at Baseline) | 275 | |
| Overall Study | COMPLETED | Cimzia at Baseline | 42 | |
| Overall Study | COMPLETED | No Cimzia at Baseline | 62 | |
| Overall Study | COMPLETED | Gap (No Cimzia and no Comparator at Baseline) | 3 | |
| Overall Study | NOT COMPLETED | Cimzia at Baseline | 1,089 | |
| Overall Study | NOT COMPLETED | No Cimzia at Baseline | 1,604 | |
| Overall Study | NOT COMPLETED | Gap (No Cimzia and no Comparator at Baseline) | 272 |
Source ClinicalTrials.gov
Adverse events2,890
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 | Crohn's disease | Gastrointestinal disorders | Cimzia | 6 | 824 | 7 |
| other | Crohn's disease | Gastrointestinal disorders | Comparator | 13 | 2,478 | 13 |
| other | Crohn's disease | Gastrointestinal disorders | Overlap | 11 | 1,165 | 12 |
| other | Crohn's disease | Gastrointestinal disorders | Gap (No Cimzia and no Comparator at Baseline) | 1 | 1,022 | 1 |
| other | Crohn's disease | Gastrointestinal disorders | Cimzia + Overlap | 17 | 1,428 | 19 |
| other | Abdominal pain | Gastrointestinal disorders | Cimzia | 6 | 824 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Comparator | 13 | 2,478 | 16 |
| other | Abdominal pain | Gastrointestinal disorders | Overlap | 6 | 1,165 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Gap (No Cimzia and no Comparator at Baseline) | 1 | 1,022 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cimzia + Overlap | 11 | 1,428 | 12 |
1 to 10 of 2,890Source ClinicalTrials.gov
See all 2,890 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cimzia | 3 | 824 |
| Total, all-cause mortality | Comparator | 25 | 2,478 |
| Total, all-cause mortality | Overlap | 6 | 1,165 |
| Total, all-cause mortality | Gap (No Cimzia and no Comparator at Baseline) | 17 | 1,022 |
| Total, all-cause mortality | Cimzia + Overlap | 9 | 1,428 |
| Total, other adverse events | Cimzia | 19 | 824 |
| Total, other adverse events | Comparator | 70 | 2,478 |
| Total, other adverse events | Overlap | 30 | 1,165 |
| Total, other adverse events | Gap (No Cimzia and no Comparator at Baseline) | 9 | 1,022 |
| Total, other adverse events | Cimzia + Overlap | 48 | 1,428 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39895830 | 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/NCT00844285
GET https://conductscience.org/api/trials/v1/NCT00844285/results?page=2