Crohn's Disease
Conditions
Brief summary
The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.
Detailed description
This study population was chosen from a non-probability sample
Interventions
BIOLOGICALInfliximab
Not specified in the protocol.
Sponsors
Centocor, Inc.
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with active luminal and/or fistulizing CD.
Exclusion criteria
* Per summary of product characteristics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | up to 2 years | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). |
| Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | up to 2 years | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). |
| Average Dose of Infliximab Per Participant Within the Observation Period | up to 2 years | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). |
| Median Dose of Infliximab Per Participant Within the Observation Period | up to 2 years | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). |
| Total Dose of Infliximab Per Participant Within the Observation Period | up to 2 years | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | 5 years | HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; \<5 (remission), 5-7 (mild disease), 8-16 (moderate disease), \>16 (severe disease). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remicade Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion. | 343 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 28 |
| Overall Study | Loss of Response | 40 |
| Overall Study | No documentation for end of therapy | 13 |
| Overall Study | No Response | 18 |
| Overall Study | Other Reason | 76 |
| Overall Study | Remission | 7 |
Baseline characteristics
| Characteristic | Remicade |
|---|---|
| Age, Continuous | 38.68 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment Austria | 343 participants |
| Sex: Female, Male Female | 178 Participants |
| Sex: Female, Male Male | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 343 |
| serious Total, serious adverse events | 43 / 343 |
Outcome results
Primary
Average Dose of Infliximab Per Participant Within the Observation Period
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Time frame: up to 2 years
Population: n = number of infliximab-naive participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade | Average Dose of Infliximab Per Participant Within the Observation Period | Infusion 1, n=315 | 5.09 mg/kg | Standard Deviation 0.66 |
| Remicade | Average Dose of Infliximab Per Participant Within the Observation Period | Infusion 2, n=300 | 5.04 mg/kg | Standard Deviation 0.67 |
| Remicade | Average Dose of Infliximab Per Participant Within the Observation Period | Infusion 3, n=276 | 5.06 mg/kg | Standard Deviation 0.62 |
| Remicade | Average Dose of Infliximab Per Participant Within the Observation Period | Infusion 4, n=253 | 5.11 mg/kg | Standard Deviation 0.76 |
| Remicade | Average Dose of Infliximab Per Participant Within the Observation Period | Infusion 5, n=227 | 5.20 mg/kg | Standard Deviation 1.02 |
| Remicade | Average Dose of Infliximab Per Participant Within the Observation Period | Infusion 6, n=210 | 5.17 mg/kg | Standard Deviation 0.95 |
| Remicade | Average Dose of Infliximab Per Participant Within the Observation Period | Infusion 7, n=186 | 5.19 mg/kg | Standard Deviation 0.92 |
| Remicade | Average Dose of Infliximab Per Participant Within the Observation Period | Infusion 8, n=163 | 5.22 mg/kg | Standard Deviation 1.03 |
| Remicade | Average Dose of Infliximab Per Participant Within the Observation Period | Infusion 9, n=148 | 5.25 mg/kg | Standard Deviation 0.97 |
Primary
Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Time frame: up to 2 years
Population: n = number of infliximab-naive participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade | Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 1 & 2, n=298 | 16.89 Days | Standard Deviation 11.35 |
| Remicade | Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 2 & 3, n=275 | 34.74 Days | Standard Deviation 17.14 |
| Remicade | Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 3 & 4, n=250 | 63.22 Days | Standard Deviation 26.07 |
| Remicade | Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 4 & 5, n=227 | 62.86 Days | Standard Deviation 26.4 |
| Remicade | Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 5 & 6, n=210 | 61.30 Days | Standard Deviation 18.03 |
| Remicade | Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 6 & 7, n=186 | 60.95 Days | Standard Deviation 20.16 |
| Remicade | Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 7 & 8, n=162 | 59.24 Days | Standard Deviation 16.81 |
| Remicade | Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 8 & 9, n=148 | 60.22 Days | Standard Deviation 16.55 |
Primary
Median Dose of Infliximab Per Participant Within the Observation Period
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Time frame: up to 2 years
Population: n = number of infliximab-naive participants
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remicade | Median Dose of Infliximab Per Participant Within the Observation Period | Infusion 1, n=315 | 5.09 mg/kg |
| Remicade | Median Dose of Infliximab Per Participant Within the Observation Period | Infusion 2, n=300 | 5.00 mg/kg |
| Remicade | Median Dose of Infliximab Per Participant Within the Observation Period | Infusion 3, n=276 | 5.00 mg/kg |
| Remicade | Median Dose of Infliximab Per Participant Within the Observation Period | Infusion 4, n=253 | 5.00 mg/kg |
| Remicade | Median Dose of Infliximab Per Participant Within the Observation Period | Infusion 5, n=227 | 5.00 mg/kg |
| Remicade | Median Dose of Infliximab Per Participant Within the Observation Period | Infusion 6, n=210 | 5.00 mg/kg |
| Remicade | Median Dose of Infliximab Per Participant Within the Observation Period | Infusion 7, n=186 | 5.08 mg/kg |
| Remicade | Median Dose of Infliximab Per Participant Within the Observation Period | Infusion 8, n=163 | 5.10 mg/kg |
| Remicade | Median Dose of Infliximab Per Participant Within the Observation Period | Infusion 9, n=148 | 5.12 mg/kg |
Primary
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Time frame: up to 2 years
Population: n = number of infliximab-naive participants
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Remicade | Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 1 & 2, n=298 | 14.00 Days |
| Remicade | Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 2 & 3, n=275 | 28.00 Days |
| Remicade | Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 3 & 4, n=250 | 56.00 Days |
| Remicade | Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 4 & 5, n=227 | 57.00 Days |
| Remicade | Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 5 & 6, n=210 | 57.00 Days |
| Remicade | Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 6 & 7, n=186 | 56.00 Days |
| Remicade | Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 7 & 8, n=162 | 56.00 Days |
| Remicade | Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Interval between infusion 8 & 9, n=148 | 56.00 Days |
Primary
Total Dose of Infliximab Per Participant Within the Observation Period
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Time frame: up to 2 years
Population: 315 of infliximab-naive participants were treated in the active phase of the study. Of these, 191 participants received induction therapy (Weeks 0, 2, and 6); 27 received only induction therapy, 132 received induction therapy and subsequent maintenance therapy, and 32 received induction therapy and subsequent episodic therapy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remicade | Total Dose of Infliximab Per Participant Within the Observation Period | 2290.32 mg/kg | Standard Deviation 1096.04 |
Secondary
Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.
HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; \<5 (remission), 5-7 (mild disease), 8-16 (moderate disease), \>16 (severe disease).
Time frame: 5 years
Population: 207 participants had disease activity analyzed using Harvey-Bradshaw Index (HBI)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remicade | Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | Infusion 1, n=44 | 8.25 Score on a scale | Standard Deviation 5.6 |
| Remicade | Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | Infusion 2, n=28 | 3.46 Score on a scale | Standard Deviation 3.69 |
| Remicade | Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | Infusion 3, n=19 | 2.21 Score on a scale | Standard Deviation 2.04 |
| Remicade | Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | Infusion 4, n=20 | 2.40 Score on a scale | Standard Deviation 2.85 |
| Remicade | Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | Infusion 5, n=23 | 2.70 Score on a scale | Standard Deviation 3.36 |
| Remicade | Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | Infusion 6, n=24 | 3.38 Score on a scale | Standard Deviation 4.19 |
| Remicade | Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | Infusion 7, n=17 | 2.06 Score on a scale | Standard Deviation 2.05 |
| Remicade | Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | Infusion 8, n=17 | 2.29 Score on a scale | Standard Deviation 2.62 |
| Remicade | Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | Infusion 9, n=15 | 2.67 Score on a scale | Standard Deviation 2.89 |