An observational study in Crohn's Disease, sponsored by UCB BIOSCIENCES, Inc.. Completed at 197 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by UCB BIOSCIENCES, Inc. (part of UCB S.A.) · Observational
The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is 3045 patients and it's objective is to monitor patients for approximately 8 years.
Physicians are expected to manage patients as they would under normal practice conditions; patients will receive and use their medications according to their normal course of medical treatment.
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 3,072 is above the median of 166 across 624 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →UCB BIOSCIENCES, Inc. is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients of selected gastroenterologists and internal medicine physicians from both community-based and academic practice settings (75% and 25% respectively) Each physician should be able to recruit a minimum of 5 patients prescribed Cimzia® and/or 5 patients prescribed other treatments.
Recruitment into both cohorts will be monitored and controlled as needed in order to ensure balanced enrollment over time. In order to ensure reasonable balance between both cohorts, retrospective frequency matching will be applied for disease severity (mild/moderate/severe), age categories and gender.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients about to receive treatment with Cimzia® as part of pre-existing management plan for Crohn's disease or has already been receiving treatment with Cimzia® for ≤12 months. Patients must also receive a Cimzia dose within 2 months following enrollment.
Drug: Cimzia
Patient must be about to receive treatment with any other medication as part of a pre-existing management plan for Crohn's disease or has already been receiving treatment (previous Cimzia® treatment is prohibited).
The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.
Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules)
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.
Time frame: Baseline up to 10 years
Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules)
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.
Time frame: Baseline up to 10 years
Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment
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.
Time frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline
Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment
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.
Time frame: 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
Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment
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.
Time frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline
Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment
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.
Time frame: 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
The study started to enroll study participants in January 2009 and concluded in August 2020.
| Milestone | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) |
|---|---|---|---|
| Started | 1131 | 1666 | 275 |
| Completed | 42 | 62 | 3 |
| Not completed | 1089 | 1604 | 272 |
| Withdrew: Other | 0 | 1 | 0 |
| Withdrew: Other than specified | 95 | 129 | 12 |
| Withdrew: Site closure | 256 | 450 | 50 |
| Withdrew: Follow-up < 8 years | 16 | 23 | 4 |
| Withdrew: Protocol violation | 26 | 28 | 54 |
| Withdrew: Death | 22 | 21 | 8 |
| Withdrew: Withdrew consent | 344 | 466 | 70 |
| Withdrew: Lost to follow-up | 330 | 486 | 74 |
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.
| no. of events per 100 participant-years | Cimzia | Comparator |
|---|---|---|
| Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) | 0.45 (0.31 to 0.65) | 0.65 (0.48 to 0.86) |
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.
| no. of events per 100 participant-years | Cimzia | Comparator | Overlap | Gap (No Cimzia and no Comparator at Baseline) | Cimzia + Overlap |
|---|---|---|---|---|---|
| Malignant or Unspecified Tumor | 0.35 (0.12 to 0.83) | 0.59 (0.44 to 0.77) | 0.60 (0.28 to 1.15) | 0.56 (0.29 to 0.97) | 0.48 (0.26 to 0.81) |
| Serious infections | 2.03 (1.35 to 2.94) | 1.59 (1.34 to 1.88) | 6.15 (4.90 to 7.61) | 1.46 (0.98 to 2.08) | 4.08 (3.36 to 4.91) |
| Opportunistic infections | 0.14 (0.02 to 0.50) | 0.08 (0.03 to 0.16) | 0.20 (0.04 to 0.59) | 0.09 (0.01 to 0.33) | 0.17 (0.06 to 0.40) |
| Serious cardiovascular events | 0.14 (0.02 to 0.50) | 0.13 (0.07 to 0.23) | 0.34 (0.11 to 0.78) | 0.23 (0.07 to 0.53) | 0.24 (0.10 to 0.49) |
| Congestive heart failure | 0 (0 to 0) | 0.08 (0.03 to 0.15) | 0.07 (0.00 to 0.37) | 0 (0 to 0) | 0.03 (0.00 to 0.19) |
| Demyelinating-like disorders | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Aplastic Anemia, Pancytopenia, Thrombocytopenia, Neutropenia, Leucopenia | 0 (0 to 0) | 0.08 (0.03 to 0.15) | 0.27 (0.07 to 0.68) | 0.14 (0.03 to 0.40) | 0.14 (0.04 to 0.35) |
| Serious bleeding events | 0.28 (0.08 to 0.73) | 0.23 (0.14 to 0.35) | 0.47 (0.19 to 0.97) | 0.14 (0.03 to 0.40) | 0.38 (0.19 to 0.68) |
| Lupus and lupus-like illness | 0 (0 to 0) | 0.06 (0.02 to 0.14) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Serious skin reactions | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
| Hepatic Events | 0.07 (0.00 to 0.39) | 0.09 (0.04 to 0.17) | 0.13 (0.02 to 0.48) | 0.05 (0.00 to 0.25) | 0.10 (0.02 to 0.30) |
| Hypersensitivity reactions and anaphylactic reactions | 0.28 (0.08 to 0.72) | 0.11 (0.05 to 0.20) | 0.60 (0.28 to 1.14) | 0 (0 to 0) | 0.44 (0.24 to 0.76) |
| Malignant lymphomas | 0.07 (0.00 to 0.39) | 0.04 (0.01 to 0.11) | 0.13 (0.02 to 0.48) | 0 (0 to 0) | 0.10 (0.02 to 0.30) |
| Non-melanoma skin cancer | 0.14 (0.02 to 0.51) | 0.24 (0.15 to 0.36) | 0.20 (0.04 to 0.59) | 0.05 (0.00 to 0.25) | 0.17 (0.06 to 0.40) |
| Autoimmune disorders | 0.35 (0.11 to 0.82) | 0.36 (0.25 to 0.50) | 0.27 (0.07 to 0.69) | 0.23 (0.07 to 0.53) | 0.31 (0.14 to 0.59) |
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.
| units on a scale | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) |
|---|---|---|---|
| Month 6 | -1.1 ± 4.3 | -0.7 ± 3.8 | -1.3 ± 4.7 |
| Month 12 | -1.2 ± 5.3 | -0.8 ± 3.8 | -1.3 ± 4.9 |
| Month 18 | -1.6 ± 4.6 | -0.8 ± 4.2 | -1.8 ± 5.5 |
| Month 24 | -1.9 ± 4.7 | -1.2 ± 3.7 | -1.3 ± 4.9 |
| Month 30 | -1.6 ± 4.7 | -1.1 ± 3.9 | -1.1 ± 4.5 |
| Month 36 | -1.8 ± 5.2 | -1.1 ± 3.6 | -1.9 ± 5.1 |
| Month 42 | -1.6 ± 5.1 | -0.9 ± 4.1 | -2.3 ± 4.0 |
| Month 48 | -1.1 ± 4.8 | -0.8 ± 3.9 | -1.9 ± 4.0 |
| Month 54 | -1.7 ± 4.8 | -0.8 ± 4.1 | -1.2 ± 4.4 |
| Month 60 | -2.0 ± 4.9 | -0.6 ± 4.0 | -1.0 ± 5.3 |
| Month 66 | -1.1 ± 4.5 | -0.8 ± 4.0 | -2.4 ± 4.6 |
| Month 72 | -1.9 ± 4.8 | -0.6 ± 3.7 | -1.6 ± 3.2 |
| Month 78 | -1.5 ± 4.7 | -0.6 ± 4.5 | -1.7 ± 4.2 |
| Month 84 | -2.3 ± 4.9 | -0.8 ± 4.5 | -1.2 ± 4.5 |
| Month 90 | -1.9 ± 4.7 | -0.9 ± 3.9 | -2.0 ± 3.9 |
| Month 96 | -2.4 ± 4.3 | -1.0 ± 3.8 | -1.6 ± 4.2 |
| Month 102 | -1.9 ± 3.9 | -1.6 ± 3.9 | -0.3 ± 3.0 |
| Month 108 | -1.8 ± 1.9 | -0.8 ± 5.3 | 0.0 ± 1.5 |
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.
| units on a scale | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) |
|---|---|---|---|
| Month 3 | 0.6 ± 4.4 | 0.2 ± 3.5 | 0.1 ± 4.7 |
| Month 6 | 0.2 ± 4.9 | -0.1 ± 3.8 | -0.0 ± 4.0 |
| Month 9 | -0.0 ± 4.7 | 0.1 ± 3.9 | -0.1 ± 4.7 |
| Month 12 | -0.5 ± 4.4 | -0.0 ± 3.8 | 0.1 ± 4.6 |
| Month 15 | -0.6 ± 4.4 | -0.2 ± 3.6 | -0.5 ± 4.1 |
| Month 18 | -0.7 ± 4.6 | -0.1 ± 3.6 | -0.3 ± 4.0 |
| Month 21 | -0.7 ± 4.9 | -0.2 ± 3.6 | 0.3 ± 5.5 |
| Month 24 | -0.6 ± 5.1 | -0.1 ± 3.6 | -0.8 ± 4.7 |
| Month 27 | -0.6 ± 4.9 | -0.0 ± 3.6 | -0.1 ± 4.7 |
| Month 30 | -0.7 ± 5.0 | -0.1 ± 3.7 | -0.3 ± 5.3 |
| Month 33 | -0.9 ± 4.8 | -0.1 ± 3.7 | -0.3 ± 5.0 |
| Month 36 | -0.6 ± 5.6 | -0.3 ± 4.0 | -0.6 ± 6.0 |
| Month 39 | -0.5 ± 5.8 | -0.3 ± 3.6 | -0.8 ± 5.3 |
| Month 42 | -0.4 ± 4.8 | -0.2 ± 3.9 | -0.8 ± 5.2 |
| Month 45 | -0.5 ± 4.7 | -0.0 ± 4.1 | -1.2 ± 4.4 |
| Month 48 | -0.7 ± 5.1 | -0.0 ± 4.0 | -0.1 ± 4.7 |
| Month 51 | -0.5 ± 5.0 | -0.1 ± 4.3 | -0.8 ± 5.0 |
| Month 54 | -0.6 ± 4.9 | -0.2 ± 4.0 | -0.6 ± 7.7 |
| Month 57 | -1.0 ± 4.9 | -0.2 ± 3.8 | -1.1 ± 5.9 |
| Month 60 | -1.2 ± 4.8 | -0.2 ± 4.3 | -0.6 ± 6.2 |
| Month 63 | -1.2 ± 4.6 | -0.4 ± 3.8 | -0.3 ± 5.7 |
| Month 66 | -1.1 ± 4.9 | -0.2 ± 4.0 | -0.2 ± 6.7 |
| Month 69 | -1.0 ± 4.7 | -0.3 ± 3.8 | -0.7 ± 5.3 |
| Month 72 | -0.8 ± 5.1 | -0.2 ± 3.9 | -1.0 ± 3.9 |
| Month 75 | -0.6 ± 5.9 | -0.1 ± 4.7 | -1.1 ± 3.6 |
| Month 78 | -1.0 ± 5.1 | -0.1 ± 4.1 | -0.6 ± 4.7 |
| Month 81 | -1.1 ± 5.1 | -0.3 ± 4.0 | -0.5 ± 3.2 |
| Month 84 | -1.0 ± 5.0 | -0.3 ± 4.2 | -0.5 ± 3.0 |
| Month 87 | -0.5 ± 5.4 | -0.2 ± 4.4 | -0.5 ± 3.5 |
| Month 90 | -0.7 ± 5.2 | 0.0 ± 4.7 | 0.3 ± 5.2 |
| Month 93 | -1.3 ± 5.0 | -0.4 ± 4.3 | -0.6 ± 3.4 |
| Month 96 | -1.1 ± 5.7 | -0.5 ± 4.6 | 0.3 ± 3.3 |
| Month 99 | -2.2 ± 6.1 | -0.4 ± 3.9 | -0.6 ± 3.5 |
| Month 102 | 0.2 ± 3.3 | 0.2 ± 2.4 | 1.3 ± 3.7 |
| Month 105 | -1.5 ± 2.1 | 2.3 ± 2.3 | 0.7 ± 2.6 |
| Month 108 | 8.0 | 2.0 ± 1.7 | 1.3 ± 3.0 |
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.
| units on a scale | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) |
|---|---|---|---|
| Month 6 | -0.4 ± 0.9 | -0.2 ± 0.8 | -0.3 ± 0.9 |
| Month 12 | -0.5 ± 1.0 | -0.3 ± 0.9 | -0.3 ± 0.9 |
| Month 18 | -0.5 ± 1.0 | -0.3 ± 0.9 | -0.3 ± 0.9 |
| Month 24 | -0.6 ± 1.0 | -0.3 ± 0.9 | -0.4 ± 0.9 |
| Month 30 | -0.6 ± 1.0 | -0.3 ± 0.9 | -0.4 ± 0.9 |
| Month 36 | -0.6 ± 1.0 | -0.4 ± 0.9 | -0.5 ± 0.9 |
| Month 42 | -0.6 ± 1.0 | -0.3 ± 0.9 | -0.5 ± 0.8 |
| Month 48 | -0.6 ± 1.0 | -0.3 ± 0.9 | -0.4 ± 0.9 |
| Month 54 | -0.6 ± 1.0 | -0.4 ± 1.0 | -0.4 ± 1.0 |
| Month 60 | -0.7 ± 1.0 | -0.3 ± 0.9 | -0.4 ± 0.9 |
| Month 66 | -0.7 ± 0.9 | -0.3 ± 0.9 | -0.4 ± 0.8 |
| Month 72 | -0.7 ± 1.0 | -0.3 ± 1.0 | -0.4 ± 0.9 |
| Month 78 | -0.7 ± 0.9 | -0.4 ± 0.9 | -0.5 ± 0.9 |
| Month 84 | -0.5 ± 1.0 | -0.4 ± 0.9 | -0.5 ± 0.8 |
| Month 90 | -0.6 ± 0.9 | -0.4 ± 0.9 | -0.7 ± 0.8 |
| Month 96 | -0.6 ± 1.0 | -0.3 ± 0.9 | -0.4 ± 1.0 |
| Month 102 | -0.4 ± 1.1 | -0.4 ± 1.1 | -0.1 ± 0.8 |
| Month 108 | -0.3 ± 1.0 | -0.1 ± 1.1 | -0.3 ± 0.5 |
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.
| units on a scale | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) |
|---|---|---|---|
| Month 3 | -0.0 ± 0.8 | -0.0 ± 0.7 | -0.1 ± 0.9 |
| Month 6 | -0.2 ± 0.9 | -0.1 ± 0.8 | -0.1 ± 0.8 |
| Month 9 | -0.2 ± 0.9 | -0.1 ± 0.9 | -0.3 ± 0.9 |
| Month 12 | -0.2 ± 0.9 | -0.1 ± 0.8 | -0.2 ± 0.8 |
| Month 15 | -0.3 ± 0.9 | -0.1 ± 0.8 | -0.2 ± 0.9 |
| Month 18 | -0.3 ± 0.9 | -0.2 ± 0.9 | -0.2 ± 0.8 |
| Month 21 | -0.3 ± 0.9 | -0.2 ± 0.8 | -0.3 ± 1.0 |
| Month 24 | -0.3 ± 1.0 | -0.2 ± 0.9 | -0.3 ± 1.0 |
| Month 27 | -0.3 ± 1.0 | -0.2 ± 0.8 | -0.4 ± 0.9 |
| Month 30 | -0.3 ± 1.0 | -0.2 ± 0.8 | -0.4 ± 0.9 |
| Month 33 | -0.4 ± 1.0 | -0.2 ± 0.9 | -0.3 ± 0.9 |
| Month 36 | -0.4 ± 1.0 | -0.2 ± 0.9 | -0.4 ± 0.9 |
| Month 39 | -0.3 ± 1.0 | -0.2 ± 0.9 | -0.3 ± 1.1 |
| Month 42 | -0.4 ± 1.0 | -0.2 ± 0.9 | -0.4 ± 0.9 |
| Month 45 | -0.3 ± 1.0 | -0.1 ± 0.8 | -0.6 ± 0.8 |
| Month 48 | -0.4 ± 1.0 | -0.2 ± 0.8 | -0.3 ± 0.9 |
| Month 51 | -0.4 ± 1.0 | -0.2 ± 0.8 | -0.3 ± 0.9 |
| Month 54 | -0.4 ± 1.0 | -0.2 ± 0.9 | -0.2 ± 1.0 |
| Month 57 | -0.4 ± 1.0 | -0.2 ± 0.8 | -0.4 ± 0.9 |
| Month 60 | -0.5 ± 1.0 | -0.3 ± 0.9 | -0.3 ± 0.9 |
| Month 63 | -0.5 ± 1.0 | -0.2 ± 0.9 | -0.1 ± 1.0 |
| Month 66 | -0.5 ± 0.9 | -0.2 ± 0.8 | -0.3 ± 0.9 |
| Month 69 | -0.5 ± 1.0 | -0.2 ± 0.9 | -0.3 ± 0.9 |
| Month 72 | -0.5 ± 0.9 | -0.2 ± 0.9 | -0.4 ± 0.8 |
| Month 75 | -0.4 ± 0.9 | -0.2 ± 0.9 | -0.4 ± 0.9 |
| Month 78 | -0.4 ± 0.9 | -0.2 ± 0.9 | -0.3 ± 0.9 |
| Month 81 | -0.5 ± 0.9 | -0.3 ± 0.9 | -0.2 ± 0.9 |
| Month 84 | -0.5 ± 0.9 | -0.3 ± 0.9 | -0.3 ± 0.9 |
| Month 87 | -0.4 ± 0.9 | -0.2 ± 0.9 | -0.2 ± 0.8 |
| Month 90 | -0.4 ± 0.9 | -0.2 ± 0.9 | -0.3 ± 0.8 |
| Month 93 | -0.4 ± 0.9 | -0.2 ± 0.9 | -0.2 ± 1.0 |
| Month 96 | -0.5 ± 0.9 | -0.2 ± 0.9 | 0.0 ± 0.9 |
| Month 99 | -0.5 ± 0.9 | -0.2 ± 0.8 | 0.1 ± 0.8 |
| Month 102 | 0.1 ± 0.9 | 0.2 ± 0.7 | 0.0 ± 0.6 |
| Month 105 | 0.5 ± 0.7 | 0.3 ± 0.6 | 0.3 ± 0.5 |
| Month 108 | 1.0 | 0.3 ± 0.6 | 0.4 ± 0.5 |
Collected over From Baseline up to 10 years. Non-serious events are listed at a 0.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cimzia | 3/824 (0.4%) | 145/824 (17.6%) | 19/824 (2.3%) |
| Comparator | 25/2,478 (1%) | 638/2,478 (25.7%) | 70/2,478 (2.8%) |
| Overlap | 6/1,165 (0.5%) | 268/1,165 (23%) | 30/1,165 (2.6%) |
| Gap (No Cimzia and no Comparator at Baseline) | 17/1,022 (1.7%) | 152/1,022 (14.9%) | 9/1,022 (0.9%) |
| Cimzia + Overlap | 9/1,428 (0.6%) | 385/1,428 (27%) | 48/1,428 (3.4%) |
| Event | Cimzia | Comparator | Overlap | Gap (No Cimzia and no Comparator at Baseline) | Cimzia + Overlap |
|---|---|---|---|---|---|
| Crohn's diseaseGastrointestinal disorders | 24/824 | 192/2478 | 101/1165 | 40/1022 | 123/1428 |
| Small intestinal obstructionGastrointestinal disorders | 23/824 | 93/2478 | 23/1165 | 18/1022 | 45/1428 |
| Abdominal painGastrointestinal disorders | 2/824 | 28/2478 | 17/1165 | 4/1022 | 19/1428 |
| Abdominal abscessInfections and infestations | 5/824 | 14/2478 | 11/1165 | 0/1022 | 16/1428 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 6/824 | 21/2478 | 8/1165 | 5/1022 | 14/1428 |
| Intestinal obstructionGastrointestinal disorders | 3/824 | 24/2478 | 9/1165 | 5/1022 | 12/1428 |
| PneumoniaInfections and infestations | 2/824 | 24/2478 | 10/1165 | 4/1022 | 12/1428 |
| CellulitisInfections and infestations | 2/824 | 8/2478 | 9/1165 | 1/1022 | 11/1428 |
| Small intestinal stenosisGastrointestinal disorders | 6/824 | 5/2478 | 1/1165 | 0/1022 | 7/1428 |
| Intestinal stenosisGastrointestinal disorders | 1/824 | 15/2478 | 7/1165 | 0/1022 | 8/1428 |
| Event | Cimzia | Comparator | Overlap | Gap (No Cimzia and no Comparator at Baseline) | Cimzia + Overlap |
|---|---|---|---|---|---|
| Crohn's diseaseGastrointestinal disorders | 6/824 | 13/2478 | 11/1165 | 1/1022 | 17/1428 |
| Abdominal painGastrointestinal disorders | 6/824 | 13/2478 | 6/1165 | 1/1022 | 11/1428 |
| Herpes zosterInfections and infestations | 2/824 | 19/2478 | 5/1165 | 3/1022 | 7/1428 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/824 | 8/2478 | 5/1165 | 2/1022 | 10/1428 |
| Clostridium difficile infectionInfections and infestations | 3/824 | 13/2478 | 6/1165 | 1/1022 | 9/1428 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/824 | 13/2478 | 1/1165 | 1/1022 | 1/1428 |
Baseline Characteristics refer to the Enrolled Set which was defined as all participants enrolled and with an informed consent.
| Age, Categorical(Participants) | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) | Total |
|---|---|---|---|---|
| <=18 years | 34 | 71 | 10 | 115 |
| Between 18 and 65 years | 1018 | 1510 | 222 | 2750 |
| >=65 years | 79 | 85 | 43 | 207 |
| Age, Continuous(years) | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) | Total |
|---|---|---|---|---|
| Mean | 39.8 ± 14.9 | 39.2 ± 14.9 | 45.0 ± 17.8 | 40.0 ± 15.3 |
| Sex/Gender, Customized(Participants) | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) | Total |
|---|---|---|---|---|
| Female | 706 | 924 | 166 | 1796 |
| Male | 425 | 740 | 104 | 1269 |
| Missing | 0 | 2 | 5 | 7 |
| Race/Ethnicity, Customized(Participants) | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) | Total |
|---|---|---|---|---|
| American Indian /Alaskan native | 2 | 4 | 1 | 7 |
| Asian | 13 | 19 | 3 | 35 |
| Black | 82 | 117 | 13 | 212 |
| Native Hawaiian or other Pacific Islander | 1 | 2 | 4 | 7 |
| White | 1017 | 1480 | 243 | 2740 |
| Other/mixed | 14 | 35 | 5 | 54 |
| Missing | 2 | 9 | 6 | 17 |
| Race/Ethnicity, Customized(Participants) | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 44 | 79 | 19 | 142 |
| Not Hispanic or Latino | 1086 | 1585 | 250 | 2921 |
| Missing | 1 | 2 | 6 | 9 |
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