Trial Outcomes & Findings for Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED) (NCT NCT00724958)
NCT ID: NCT00724958
Last Updated: 2015-10-02
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
348 participants
Primary outcome timeframe
up to 2 years
Results posted on
2015-10-02
Participant Flow
Participant milestones
| Measure |
Remicade
Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
|
|---|---|
|
Overall Study
STARTED
|
348
|
|
Overall Study
COMPLETED
|
166
|
|
Overall Study
NOT COMPLETED
|
182
|
Reasons for withdrawal
| Measure |
Remicade
Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
|
|---|---|
|
Overall Study
Adverse Event
|
28
|
|
Overall Study
Loss of Response
|
40
|
|
Overall Study
No Response
|
18
|
|
Overall Study
Remission
|
7
|
|
Overall Study
Other Reason
|
76
|
|
Overall Study
No documentation for end of therapy
|
13
|
Baseline Characteristics
Program Extension of Real Life Dosing of Remicade in Austria for Crohn's Disease (Study P04052)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Remicade
n=343 Participants
Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion.
|
|---|---|
|
Age, Continuous
|
38.68 years
STANDARD_DEVIATION 12.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
165 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
343 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: n = number of infliximab-naive participants
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).
Outcome measures
| Measure |
Remicade
n=298 Participants
Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Interval between infusion 4 & 5, n=227
|
62.86 Days
Standard Deviation 26.40
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: up to 2 yearsPopulation: n = number of infliximab-naive participants
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).
Outcome measures
| Measure |
Remicade
n=298 Participants
Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
|
|---|---|
|
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Interval between infusion 1 & 2, n=298
|
14.00 Days
Interval 5.0 to 129.0
|
|
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Interval between infusion 2 & 3, n=275
|
28.00 Days
Interval 11.0 to 182.0
|
|
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Interval between infusion 3 & 4, n=250
|
56.00 Days
Interval 18.0 to 266.0
|
|
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Interval between infusion 4 & 5, n=227
|
57.00 Days
Interval 14.0 to 273.0
|
|
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Interval between infusion 5 & 6, n=210
|
57.00 Days
Interval 23.0 to 184.0
|
|
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Interval between infusion 6 & 7, n=186
|
56.00 Days
Interval 24.0 to 214.0
|
|
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Interval between infusion 7 & 8, n=162
|
56.00 Days
Interval 15.0 to 161.0
|
|
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
Interval between infusion 8 & 9, n=148
|
56.00 Days
Interval 11.0 to 140.0
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: n = number of infliximab-naive participants
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).
Outcome measures
| Measure |
Remicade
n=315 Participants
Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
|
|---|---|
|
Average Dose of Infliximab Per Participant Within the Observation Period
Infusion 1, n=315
|
5.09 mg/kg
Standard Deviation 0.66
|
|
Average Dose of Infliximab Per Participant Within the Observation Period
Infusion 2, n=300
|
5.04 mg/kg
Standard Deviation 0.67
|
|
Average Dose of Infliximab Per Participant Within the Observation Period
Infusion 3, n=276
|
5.06 mg/kg
Standard Deviation 0.62
|
|
Average Dose of Infliximab Per Participant Within the Observation Period
Infusion 4, n=253
|
5.11 mg/kg
Standard Deviation 0.76
|
|
Average Dose of Infliximab Per Participant Within the Observation Period
Infusion 5, n=227
|
5.20 mg/kg
Standard Deviation 1.02
|
|
Average Dose of Infliximab Per Participant Within the Observation Period
Infusion 6, n=210
|
5.17 mg/kg
Standard Deviation 0.95
|
|
Average Dose of Infliximab Per Participant Within the Observation Period
Infusion 7, n=186
|
5.19 mg/kg
Standard Deviation 0.92
|
|
Average Dose of Infliximab Per Participant Within the Observation Period
Infusion 8, n=163
|
5.22 mg/kg
Standard Deviation 1.03
|
|
Average Dose of Infliximab Per Participant Within the Observation Period
Infusion 9, n=148
|
5.25 mg/kg
Standard Deviation 0.97
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: n = number of infliximab-naive participants
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).
Outcome measures
| Measure |
Remicade
n=315 Participants
Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
|
|---|---|
|
Median Dose of Infliximab Per Participant Within the Observation Period
Infusion 6, n=210
|
5.00 mg/kg
Interval 3.41 to 11.36
|
|
Median Dose of Infliximab Per Participant Within the Observation Period
Infusion 7, n=186
|
5.08 mg/kg
Interval 3.41 to 11.43
|
|
Median Dose of Infliximab Per Participant Within the Observation Period
Infusion 1, n=315
|
5.09 mg/kg
Interval 2.56 to 8.62
|
|
Median Dose of Infliximab Per Participant Within the Observation Period
Infusion 2, n=300
|
5.00 mg/kg
Interval 2.31 to 8.77
|
|
Median Dose of Infliximab Per Participant Within the Observation Period
Infusion 3, n=276
|
5.00 mg/kg
Interval 3.19 to 8.77
|
|
Median Dose of Infliximab Per Participant Within the Observation Period
Infusion 4, n=253
|
5.00 mg/kg
Interval 3.66 to 11.43
|
|
Median Dose of Infliximab Per Participant Within the Observation Period
Infusion 5, n=227
|
5.00 mg/kg
Interval 3.64 to 11.43
|
|
Median Dose of Infliximab Per Participant Within the Observation Period
Infusion 8, n=163
|
5.10 mg/kg
Interval 3.41 to 11.11
|
|
Median Dose of Infliximab Per Participant Within the Observation Period
Infusion 9, n=148
|
5.12 mg/kg
Interval 3.37 to 9.84
|
PRIMARY outcome
Timeframe: up to 2 yearsPopulation: 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.
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).
Outcome measures
| Measure |
Remicade
n=315 Participants
Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
|
|---|---|
|
Total Dose of Infliximab Per Participant Within the Observation Period
|
2290.32 mg/kg
Standard Deviation 1096.04
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 207 participants had disease activity analyzed using Harvey-Bradshaw Index (HBI)
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).
Outcome measures
| Measure |
Remicade
n=207 Participants
Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
|
|---|---|
|
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 5.60
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Remicade
Serious events: 43 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Remicade
n=343 participants at risk
Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting.
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.29%
1/343 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.29%
1/343 • Number of events 1
|
|
Gastrointestinal disorders
Colonic Stenosis
|
0.29%
1/343 • Number of events 1
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.29%
1/343 • Number of events 1
|
|
Gastrointestinal disorders
Ileal Stenosis
|
0.29%
1/343 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/343 • Number of events 1
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.29%
1/343 • Number of events 1
|
|
Gastrointestinal disorders
Small Intestinal Stenosis
|
0.58%
2/343 • Number of events 2
|
|
Gastrointestinal disorders
Subileus
|
0.58%
2/343 • Number of events 4
|
|
Immune system disorders
Anaphylactic Reaction
|
0.58%
2/343 • Number of events 2
|
|
Immune system disorders
Cytokine Release Syndrome
|
0.29%
1/343 • Number of events 1
|
|
Immune system disorders
Drug Hypersensitivity
|
0.58%
2/343 • Number of events 2
|
|
Infections and infestations
Abscess
|
0.87%
3/343 • Number of events 3
|
|
Infections and infestations
Anal Abscess
|
0.58%
2/343 • Number of events 2
|
|
Infections and infestations
Herpes Virus Infection
|
0.29%
1/343 • Number of events 1
|
|
Infections and infestations
Nasal Abscess
|
0.29%
1/343 • Number of events 1
|
|
Infections and infestations
Perirectal Abscess
|
0.29%
1/343 • Number of events 1
|
|
Infections and infestations
Sepsis
|
0.58%
2/343 • Number of events 2
|
|
Investigations
Aspiration Bone Marrow
|
0.29%
1/343 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.29%
1/343 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.29%
1/343 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.29%
1/343 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell Lymphoma
|
0.29%
1/343 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma
|
0.29%
1/343 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.29%
1/343 • Number of events 1
|
|
Nervous system disorders
Cluster Headache
|
0.29%
1/343 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.58%
2/343 • Number of events 2
|
|
Nervous system disorders
Simple Partial Seizures
|
0.29%
1/343 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.58%
2/343 • Number of events 2
|
|
Surgical and medical procedures
Abscess Drainage
|
1.2%
4/343 • Number of events 4
|
|
Surgical and medical procedures
Appendicectomy
|
0.29%
1/343 • Number of events 1
|
|
Surgical and medical procedures
Colectomy
|
0.29%
1/343 • Number of events 1
|
|
Surgical and medical procedures
Enterostomy
|
0.29%
1/343 • Number of events 1
|
|
Surgical and medical procedures
Enterostomy Closure
|
0.29%
1/343 • Number of events 1
|
|
Surgical and medical procedures
Hospitalization
|
0.87%
3/343 • Number of events 3
|
|
Surgical and medical procedures
Intestinal Operation
|
0.58%
2/343 • Number of events 2
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place