Crohn's Disease
Conditions
Keywords
Certolizumab Pegol, Cimzia ®, Crohn's Disease
Brief summary
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.
Detailed description
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.
Interventions
DRUGCimzia
The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.
Sponsors
UCB BIOSCIENCES, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must have medically documented Crohn's disease (CD) * The decision to prescribe Cimzia or other medications has been made by the physician independent of inclusion in this study * Patient (or his/her legally acceptable representative) is able to provide written informed consent to permit collection of data * Patients participating in randomized, blinded clinical trials for CD or other conditions are not eligible for inclusion into the SECURE registry. Involvement in other registries, where patients follow routine clinical practice, is permitted, however * For the Cimzia cohort: Patient is receiving treatment with Cimzia for the first time. Patient must receive Cimzia treatment within 2 months of enrollment into the registry * Patient is currently receiving treatment with Cimzia for \<=12 months. Patient must also receive a Cimzia dose within 2 months following enrollment into the registry * For the comparison cohort: Patient is switching CD treatment or beginning CD treatment for the first time. Previous Cimzia treatment is prohibited in the comparator group. Patient must receive new CD treatment within 2 months of enrollment into the registry. Patient is currently receiving anti-TNF treatment for \<=12 months. Patient must receive anti-TNF treatment within 2 months following enrollment into the registry. Patient is currently receiving immunosuppressant therapy for \<=12 months. Patient must receive immunosuppressant therapy within 2 months following enrollment into the registry. Patient is currently receiving systemic steroid therapy for \<=12 months. Patient must receive systemic steroid therapy within 2 months following enrollment into registry.
Exclusion criteria
* See inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
The study started to enroll study participants in January 2009 and concluded in August 2020.
Pre-assignment details
Participant flow refers to the Enrolled Set.
Participants by arm
| Arm | Count |
|---|---|
| Cimzia at Baseline Participants who received Cimzia® up to 70 days prior to Baseline. | 1,131 |
| No Cimzia at Baseline Participants not in the Cimzia® at Baseline group receiving corticosteroids, immunosuppressants or other biologics (e.g. anti-TNFs) other than Cimzia® at Baseline. | 1,666 |
| Gap (No Cimzia and no Comparator at Baseline) Participants who did not receive Cimzia® within 70 days prior to Baseline nor corticosteroids, immunosuppressants or other biologics (e.g. anti-TNFs) other than Cimzia® at Baseline. | 275 |
| Total | 3,072 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 22 | 21 | 8 |
| Overall Study | Follow-up < 8 years | 16 | 23 | 4 |
| Overall Study | Lost to Follow-up | 330 | 486 | 74 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Other than specified | 95 | 129 | 12 |
| Overall Study | Protocol Violation | 26 | 28 | 54 |
| Overall Study | Site closure | 256 | 450 | 50 |
| Overall Study | Withdrew Consent | 344 | 466 | 70 |
Baseline characteristics
| Characteristic | Cimzia at Baseline | No Cimzia at Baseline | Gap (No Cimzia and no Comparator at Baseline) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 34 Participants | 71 Participants | 10 Participants | 115 Participants |
| Age, Categorical >=65 years | 79 Participants | 85 Participants | 43 Participants | 207 Participants |
| Age, Categorical Between 18 and 65 years | 1018 Participants | 1510 Participants | 222 Participants | 2750 Participants |
| Age, Continuous | 39.8 years STANDARD_DEVIATION 14.9 | 39.2 years STANDARD_DEVIATION 14.9 | 45.0 years STANDARD_DEVIATION 17.8 | 40.0 years STANDARD_DEVIATION 15.3 |
| Race/Ethnicity, Customized American Indian /Alaskan native | 2 Participants | 4 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 19 Participants | 3 Participants | 35 Participants |
| Race/Ethnicity, Customized Black | 82 Participants | 117 Participants | 13 Participants | 212 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 44 Participants | 79 Participants | 19 Participants | 142 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 2 Participants | 6 Participants | 17 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 2 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 1086 Participants | 1585 Participants | 250 Participants | 2921 Participants |
| Race/Ethnicity, Customized Other/mixed | 14 Participants | 35 Participants | 5 Participants | 54 Participants |
| Race/Ethnicity, Customized White | 1017 Participants | 1480 Participants | 243 Participants | 2740 Participants |
| Sex/Gender, Customized Female | 706 Participants | 924 Participants | 166 Participants | 1796 Participants |
| Sex/Gender, Customized Male | 425 Participants | 740 Participants | 104 Participants | 1269 Participants |
| Sex/Gender, Customized Missing | 0 Participants | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 824 | 25 / 2,478 | 6 / 1,165 | 17 / 1,022 | 9 / 1,428 |
| other Total, other adverse events | 19 / 824 | 70 / 2,478 | 30 / 1,165 | 9 / 1,022 | 48 / 1,428 |
| serious Total, serious adverse events | 145 / 824 | 638 / 2,478 | 268 / 1,165 | 152 / 1,022 | 385 / 1,428 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) | 0.45 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) | 0.65 no. of events per 100 participant-years |
Primary
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
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious bleeding events | 0.28 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Congestive heart failure | 0 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Hypersensitivity reactions and anaphylactic reactions | 0.28 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Hepatic Events | 0.07 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Malignant lymphomas | 0.07 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious infections | 2.03 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Demyelinating-like disorders | 0 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Lupus and lupus-like illness | 0 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious skin reactions | 0 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious cardiovascular events | 0.14 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Autoimmune disorders | 0.35 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Aplastic Anemia, Pancytopenia, Thrombocytopenia, Neutropenia, Leucopenia | 0 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Non-melanoma skin cancer | 0.14 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Opportunistic infections | 0.14 no. of events per 100 participant-years |
| Cimzia | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Malignant or Unspecified Tumor | 0.35 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious bleeding events | 0.23 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Hypersensitivity reactions and anaphylactic reactions | 0.11 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Opportunistic infections | 0.08 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Lupus and lupus-like illness | 0.06 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Autoimmune disorders | 0.36 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious skin reactions | 0 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Hepatic Events | 0.09 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Non-melanoma skin cancer | 0.24 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Malignant lymphomas | 0.04 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Malignant or Unspecified Tumor | 0.59 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Congestive heart failure | 0.08 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Aplastic Anemia, Pancytopenia, Thrombocytopenia, Neutropenia, Leucopenia | 0.08 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Demyelinating-like disorders | 0 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious infections | 1.59 no. of events per 100 participant-years |
| Comparator | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious cardiovascular events | 0.13 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Non-melanoma skin cancer | 0.20 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious cardiovascular events | 0.34 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious infections | 6.15 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious skin reactions | 0 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Autoimmune disorders | 0.27 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Congestive heart failure | 0.07 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Demyelinating-like disorders | 0 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Malignant or Unspecified Tumor | 0.60 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Aplastic Anemia, Pancytopenia, Thrombocytopenia, Neutropenia, Leucopenia | 0.27 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious bleeding events | 0.47 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Lupus and lupus-like illness | 0 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Opportunistic infections | 0.20 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Hepatic Events | 0.13 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Hypersensitivity reactions and anaphylactic reactions | 0.60 no. of events per 100 participant-years |
| Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Malignant lymphomas | 0.13 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Hepatic Events | 0.05 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Malignant or Unspecified Tumor | 0.56 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Lupus and lupus-like illness | 0 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious bleeding events | 0.14 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious cardiovascular events | 0.23 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Hypersensitivity reactions and anaphylactic reactions | 0 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Demyelinating-like disorders | 0 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Congestive heart failure | 0 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Autoimmune disorders | 0.23 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Non-melanoma skin cancer | 0.05 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Malignant lymphomas | 0 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Aplastic Anemia, Pancytopenia, Thrombocytopenia, Neutropenia, Leucopenia | 0.14 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Opportunistic infections | 0.09 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious skin reactions | 0 no. of events per 100 participant-years |
| Gap (No Cimzia and no Comparator at Baseline) | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious infections | 1.46 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Autoimmune disorders | 0.31 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Malignant or Unspecified Tumor | 0.48 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious infections | 4.08 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Opportunistic infections | 0.17 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious cardiovascular events | 0.24 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Congestive heart failure | 0.03 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Demyelinating-like disorders | 0 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Aplastic Anemia, Pancytopenia, Thrombocytopenia, Neutropenia, Leucopenia | 0.14 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious bleeding events | 0.38 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Lupus and lupus-like illness | 0 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Serious skin reactions | 0 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Hepatic Events | 0.10 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Hypersensitivity reactions and anaphylactic reactions | 0.44 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Malignant lymphomas | 0.10 no. of events per 100 participant-years |
| Cimzia + Overlap | Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Non-melanoma skin cancer | 0.17 no. of events per 100 participant-years |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 39 | -0.3 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 105 | 0.5 units on a scale | Standard Deviation 0.7 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 75 | -0.4 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 42 | -0.4 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 3 | -0.0 units on a scale | Standard Deviation 0.8 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 72 | -0.5 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 45 | -0.3 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 18 | -0.3 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 69 | -0.5 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 48 | -0.4 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 9 | -0.2 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 66 | -0.5 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 51 | -0.4 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 96 | -0.5 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 63 | -0.5 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 54 | -0.4 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 21 | -0.3 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 60 | -0.5 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 57 | -0.4 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 6 | -0.2 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 93 | -0.4 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 24 | -0.3 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 102 | 0.1 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 90 | -0.4 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 27 | -0.3 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 12 | -0.2 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 87 | -0.4 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 30 | -0.3 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 108 | 1.0 units on a scale | — |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 84 | -0.5 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 33 | -0.4 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 99 | -0.5 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 81 | -0.5 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 36 | -0.4 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 15 | -0.3 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 78 | -0.4 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 96 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 3 | -0.0 units on a scale | Standard Deviation 0.7 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 6 | -0.1 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 9 | -0.1 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 12 | -0.1 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 15 | -0.1 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 18 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 21 | -0.2 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 24 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 27 | -0.2 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 30 | -0.2 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 33 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 36 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 39 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 42 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 45 | -0.1 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 48 | -0.2 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 51 | -0.2 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 54 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 57 | -0.2 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 60 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 63 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 66 | -0.2 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 69 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 72 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 75 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 78 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 81 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 84 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 87 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 90 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 93 | -0.2 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 99 | -0.2 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 102 | 0.2 units on a scale | Standard Deviation 0.7 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 105 | 0.3 units on a scale | Standard Deviation 0.6 |
| Comparator | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 108 | 0.3 units on a scale | Standard Deviation 0.6 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 39 | -0.3 units on a scale | Standard Deviation 1.1 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 105 | 0.3 units on a scale | Standard Deviation 0.5 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 75 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 36 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 99 | 0.1 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 78 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 33 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 9 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 81 | -0.2 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 30 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 3 | -0.1 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 84 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 27 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 102 | 0.0 units on a scale | Standard Deviation 0.6 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 87 | -0.2 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 24 | -0.3 units on a scale | Standard Deviation 1 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 6 | -0.1 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 90 | -0.3 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 21 | -0.3 units on a scale | Standard Deviation 1 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 108 | 0.4 units on a scale | Standard Deviation 0.5 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 57 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 54 | -0.2 units on a scale | Standard Deviation 1 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 93 | -0.2 units on a scale | Standard Deviation 1 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 60 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 51 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 18 | -0.2 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 63 | -0.1 units on a scale | Standard Deviation 1 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 48 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 15 | -0.2 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 66 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 45 | -0.6 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 96 | 0.0 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 69 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 42 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 12 | -0.2 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 72 | -0.4 units on a scale | Standard Deviation 0.8 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 39 | -0.5 units on a scale | Standard Deviation 5.8 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 105 | -1.5 units on a scale | Standard Deviation 2.1 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 75 | -0.6 units on a scale | Standard Deviation 5.9 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 42 | -0.4 units on a scale | Standard Deviation 4.8 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 3 | 0.6 units on a scale | Standard Deviation 4.4 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 72 | -0.8 units on a scale | Standard Deviation 5.1 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 45 | -0.5 units on a scale | Standard Deviation 4.7 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 18 | -0.7 units on a scale | Standard Deviation 4.6 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 69 | -1.0 units on a scale | Standard Deviation 4.7 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 48 | -0.7 units on a scale | Standard Deviation 5.1 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 9 | -0.0 units on a scale | Standard Deviation 4.7 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 66 | -1.1 units on a scale | Standard Deviation 4.9 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 51 | -0.5 units on a scale | Standard Deviation 5 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 96 | -1.1 units on a scale | Standard Deviation 5.7 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 63 | -1.2 units on a scale | Standard Deviation 4.6 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 54 | -0.6 units on a scale | Standard Deviation 4.9 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 21 | -0.7 units on a scale | Standard Deviation 4.9 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 60 | -1.2 units on a scale | Standard Deviation 4.8 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 57 | -1.0 units on a scale | Standard Deviation 4.9 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 6 | 0.2 units on a scale | Standard Deviation 4.9 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 93 | -1.3 units on a scale | Standard Deviation 5 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 24 | -0.6 units on a scale | Standard Deviation 5.1 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 102 | 0.2 units on a scale | Standard Deviation 3.3 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 90 | -0.7 units on a scale | Standard Deviation 5.2 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 27 | -0.6 units on a scale | Standard Deviation 4.9 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 12 | -0.5 units on a scale | Standard Deviation 4.4 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 87 | -0.5 units on a scale | Standard Deviation 5.4 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 30 | -0.7 units on a scale | Standard Deviation 5 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 108 | 8.0 units on a scale | — |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 84 | -1.0 units on a scale | Standard Deviation 5 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 33 | -0.9 units on a scale | Standard Deviation 4.8 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 99 | -2.2 units on a scale | Standard Deviation 6.1 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 81 | -1.1 units on a scale | Standard Deviation 5.1 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 36 | -0.6 units on a scale | Standard Deviation 5.6 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 15 | -0.6 units on a scale | Standard Deviation 4.4 |
| Cimzia | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 78 | -1.0 units on a scale | Standard Deviation 5.1 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 96 | -0.5 units on a scale | Standard Deviation 4.6 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 3 | 0.2 units on a scale | Standard Deviation 3.5 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 6 | -0.1 units on a scale | Standard Deviation 3.8 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 9 | 0.1 units on a scale | Standard Deviation 3.9 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 12 | -0.0 units on a scale | Standard Deviation 3.8 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 15 | -0.2 units on a scale | Standard Deviation 3.6 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 18 | -0.1 units on a scale | Standard Deviation 3.6 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 21 | -0.2 units on a scale | Standard Deviation 3.6 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 24 | -0.1 units on a scale | Standard Deviation 3.6 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 27 | -0.0 units on a scale | Standard Deviation 3.6 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 30 | -0.1 units on a scale | Standard Deviation 3.7 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 33 | -0.1 units on a scale | Standard Deviation 3.7 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 36 | -0.3 units on a scale | Standard Deviation 4 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 39 | -0.3 units on a scale | Standard Deviation 3.6 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 42 | -0.2 units on a scale | Standard Deviation 3.9 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 45 | -0.0 units on a scale | Standard Deviation 4.1 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 48 | -0.0 units on a scale | Standard Deviation 4 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 51 | -0.1 units on a scale | Standard Deviation 4.3 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 54 | -0.2 units on a scale | Standard Deviation 4 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 57 | -0.2 units on a scale | Standard Deviation 3.8 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 60 | -0.2 units on a scale | Standard Deviation 4.3 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 63 | -0.4 units on a scale | Standard Deviation 3.8 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 66 | -0.2 units on a scale | Standard Deviation 4 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 69 | -0.3 units on a scale | Standard Deviation 3.8 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 72 | -0.2 units on a scale | Standard Deviation 3.9 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 75 | -0.1 units on a scale | Standard Deviation 4.7 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 78 | -0.1 units on a scale | Standard Deviation 4.1 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 81 | -0.3 units on a scale | Standard Deviation 4 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 84 | -0.3 units on a scale | Standard Deviation 4.2 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 87 | -0.2 units on a scale | Standard Deviation 4.4 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 90 | 0.0 units on a scale | Standard Deviation 4.7 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 93 | -0.4 units on a scale | Standard Deviation 4.3 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 99 | -0.4 units on a scale | Standard Deviation 3.9 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 102 | 0.2 units on a scale | Standard Deviation 2.4 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 105 | 2.3 units on a scale | Standard Deviation 2.3 |
| Comparator | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 108 | 2.0 units on a scale | Standard Deviation 1.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 39 | -0.8 units on a scale | Standard Deviation 5.3 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 105 | 0.7 units on a scale | Standard Deviation 2.6 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 75 | -1.1 units on a scale | Standard Deviation 3.6 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 36 | -0.6 units on a scale | Standard Deviation 6 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 99 | -0.6 units on a scale | Standard Deviation 3.5 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 78 | -0.6 units on a scale | Standard Deviation 4.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 33 | -0.3 units on a scale | Standard Deviation 5 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 9 | -0.1 units on a scale | Standard Deviation 4.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 81 | -0.5 units on a scale | Standard Deviation 3.2 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 30 | -0.3 units on a scale | Standard Deviation 5.3 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 3 | 0.1 units on a scale | Standard Deviation 4.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 84 | -0.5 units on a scale | Standard Deviation 3 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 27 | -0.1 units on a scale | Standard Deviation 4.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 102 | 1.3 units on a scale | Standard Deviation 3.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 87 | -0.5 units on a scale | Standard Deviation 3.5 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 24 | -0.8 units on a scale | Standard Deviation 4.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 6 | -0.0 units on a scale | Standard Deviation 4 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 90 | 0.3 units on a scale | Standard Deviation 5.2 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 21 | 0.3 units on a scale | Standard Deviation 5.5 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 108 | 1.3 units on a scale | Standard Deviation 3 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 57 | -1.1 units on a scale | Standard Deviation 5.9 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 54 | -0.6 units on a scale | Standard Deviation 7.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 93 | -0.6 units on a scale | Standard Deviation 3.4 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 60 | -0.6 units on a scale | Standard Deviation 6.2 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 51 | -0.8 units on a scale | Standard Deviation 5 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 18 | -0.3 units on a scale | Standard Deviation 4 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 63 | -0.3 units on a scale | Standard Deviation 5.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 48 | -0.1 units on a scale | Standard Deviation 4.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 15 | -0.5 units on a scale | Standard Deviation 4.1 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 66 | -0.2 units on a scale | Standard Deviation 6.7 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 45 | -1.2 units on a scale | Standard Deviation 4.4 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 96 | 0.3 units on a scale | Standard Deviation 3.3 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 69 | -0.7 units on a scale | Standard Deviation 5.3 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 42 | -0.8 units on a scale | Standard Deviation 5.2 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 12 | 0.1 units on a scale | Standard Deviation 4.6 |
| Overlap | Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 72 | -1.0 units on a scale | Standard Deviation 3.9 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 96 | -0.6 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 54 | -0.6 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 24 | -0.6 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 78 | -0.7 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 48 | -0.6 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 30 | -0.6 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 108 | -0.3 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 42 | -0.6 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 36 | -0.6 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 90 | -0.6 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 72 | -0.7 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 6 | -0.4 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 84 | -0.5 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 66 | -0.7 units on a scale | Standard Deviation 0.9 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 12 | -0.5 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 102 | -0.4 units on a scale | Standard Deviation 1.1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 60 | -0.7 units on a scale | Standard Deviation 1 |
| Cimzia | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 18 | -0.5 units on a scale | Standard Deviation 1 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 48 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 96 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 102 | -0.4 units on a scale | Standard Deviation 1.1 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 108 | -0.1 units on a scale | Standard Deviation 1.1 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 6 | -0.2 units on a scale | Standard Deviation 0.8 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 12 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 18 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 24 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 30 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 36 | -0.4 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 42 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 90 | -0.4 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 54 | -0.4 units on a scale | Standard Deviation 1 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 60 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 66 | -0.3 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 72 | -0.3 units on a scale | Standard Deviation 1 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 78 | -0.4 units on a scale | Standard Deviation 0.9 |
| Comparator | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 84 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 84 | -0.5 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 54 | -0.4 units on a scale | Standard Deviation 1 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 12 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 78 | -0.5 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 60 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 6 | -0.3 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 96 | -0.4 units on a scale | Standard Deviation 1 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 66 | -0.4 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 108 | -0.3 units on a scale | Standard Deviation 0.5 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 90 | -0.7 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 36 | -0.5 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 30 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 72 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 42 | -0.5 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 24 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 102 | -0.1 units on a scale | Standard Deviation 0.8 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 48 | -0.4 units on a scale | Standard Deviation 0.9 |
| Overlap | Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment | Month 18 | -0.3 units on a scale | Standard Deviation 0.9 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 18 | -1.6 units on a scale | Standard Deviation 4.6 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 6 | -1.1 units on a scale | Standard Deviation 4.3 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 12 | -1.2 units on a scale | Standard Deviation 5.3 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 24 | -1.9 units on a scale | Standard Deviation 4.7 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 30 | -1.6 units on a scale | Standard Deviation 4.7 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 36 | -1.8 units on a scale | Standard Deviation 5.2 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 42 | -1.6 units on a scale | Standard Deviation 5.1 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 48 | -1.1 units on a scale | Standard Deviation 4.8 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 54 | -1.7 units on a scale | Standard Deviation 4.8 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 60 | -2.0 units on a scale | Standard Deviation 4.9 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 66 | -1.1 units on a scale | Standard Deviation 4.5 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 72 | -1.9 units on a scale | Standard Deviation 4.8 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 78 | -1.5 units on a scale | Standard Deviation 4.7 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 84 | -2.3 units on a scale | Standard Deviation 4.9 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 90 | -1.9 units on a scale | Standard Deviation 4.7 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 96 | -2.4 units on a scale | Standard Deviation 4.3 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 102 | -1.9 units on a scale | Standard Deviation 3.9 |
| Cimzia | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 108 | -1.8 units on a scale | Standard Deviation 1.9 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 108 | -0.8 units on a scale | Standard Deviation 5.3 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 78 | -0.6 units on a scale | Standard Deviation 4.5 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 6 | -0.7 units on a scale | Standard Deviation 3.8 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 60 | -0.6 units on a scale | Standard Deviation 4 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 90 | -0.9 units on a scale | Standard Deviation 3.9 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 12 | -0.8 units on a scale | Standard Deviation 3.8 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 96 | -1.0 units on a scale | Standard Deviation 3.8 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 18 | -0.8 units on a scale | Standard Deviation 4.2 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 66 | -0.8 units on a scale | Standard Deviation 4 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 102 | -1.6 units on a scale | Standard Deviation 3.9 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 24 | -1.2 units on a scale | Standard Deviation 3.7 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 54 | -0.8 units on a scale | Standard Deviation 4.1 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 84 | -0.8 units on a scale | Standard Deviation 4.5 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 30 | -1.1 units on a scale | Standard Deviation 3.9 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 48 | -0.8 units on a scale | Standard Deviation 3.9 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 72 | -0.6 units on a scale | Standard Deviation 3.7 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 36 | -1.1 units on a scale | Standard Deviation 3.6 |
| Comparator | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 42 | -0.9 units on a scale | Standard Deviation 4.1 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 36 | -1.9 units on a scale | Standard Deviation 5.1 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 42 | -2.3 units on a scale | Standard Deviation 4 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 48 | -1.9 units on a scale | Standard Deviation 4 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 90 | -2.0 units on a scale | Standard Deviation 3.9 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 54 | -1.2 units on a scale | Standard Deviation 4.4 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 108 | 0.0 units on a scale | Standard Deviation 1.5 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 60 | -1.0 units on a scale | Standard Deviation 5.3 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 66 | -2.4 units on a scale | Standard Deviation 4.6 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 96 | -1.6 units on a scale | Standard Deviation 4.2 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 72 | -1.6 units on a scale | Standard Deviation 3.2 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 6 | -1.3 units on a scale | Standard Deviation 4.7 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 78 | -1.7 units on a scale | Standard Deviation 4.2 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 12 | -1.3 units on a scale | Standard Deviation 4.9 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 18 | -1.8 units on a scale | Standard Deviation 5.5 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 24 | -1.3 units on a scale | Standard Deviation 4.9 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 30 | -1.1 units on a scale | Standard Deviation 4.5 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 84 | -1.2 units on a scale | Standard Deviation 4.5 |
| Overlap | Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | Month 102 | -0.3 units on a scale | Standard Deviation 3 |