Trial Outcomes & Findings for Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED) (NCT NCT00725621)
NCT ID: NCT00725621
Last Updated: 2015-09-03
Results Overview
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Recruitment status
COMPLETED
Target enrollment
516 participants
Primary outcome timeframe
Maximum of 16 weeks
Results posted on
2015-09-03
Participant Flow
Participant milestones
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
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|---|---|
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Overall Study
STARTED
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516
|
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Overall Study
COMPLETED
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245
|
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Overall Study
NOT COMPLETED
|
271
|
Reasons for withdrawal
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
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|---|---|
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Overall Study
Adverse Event
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25
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Overall Study
Lack of Efficacy
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46
|
|
Overall Study
Withdrawal by Subject
|
57
|
|
Overall Study
Physician Decision
|
19
|
|
Overall Study
Lost to Follow-up
|
52
|
|
Overall Study
Non-compliance
|
8
|
|
Overall Study
Continued treatment by other physician
|
6
|
|
Overall Study
Switched to other study
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1
|
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Overall Study
Switched to other drug
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1
|
|
Overall Study
Prepared for elective surgery
|
1
|
|
Overall Study
Reason not specified
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55
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Baseline Characteristics
Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=516 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
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|---|---|
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Age, Continuous
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55.43 years
STANDARD_DEVIATION 13.52 • n=5 Participants
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|
Sex: Female, Male
Female
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398 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Maximum of 16 weeksPopulation: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Outcome measures
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=193 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Specialized Hospitals Only)
n=120 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Extramural Infusion Centers Only)
n=73 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
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|---|---|---|---|
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Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 3/4 (n=193, n=120, n=73)
|
56.48 Days
Standard Deviation 10.94
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56.32 Days
Standard Deviation 7.76
|
56.75 Days
Standard Deviation 14.82
|
|
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 4/5 (n=193, n=120, n=73)
|
57.55 Days
Standard Deviation 10.81
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56.83 Days
Standard Deviation 10.66
|
58.73 Days
Standard Deviation 11.03
|
|
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 5/6 (n=178, n=110, n=68)
|
56.80 Days
Standard Deviation 10.85
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56.60 Days
Standard Deviation 13.07
|
57.13 Days
Standard Deviation 5.75
|
|
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 6/7 (n=163, n=99, n=64)
|
56.07 Days
Standard Deviation 8.57
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55.41 Days
Standard Deviation 8.56
|
57.09 Days
Standard Deviation 8.56
|
|
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 7/8 (n=153, n=91, n=62)
|
57.33 Days
Standard Deviation 10.97
|
56.43 Days
Standard Deviation 12.11
|
58.65 Days
Standard Deviation 8.97
|
|
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 8/9 (n=143, n=83, n=60)
|
57.04 Days
Standard Deviation 11.07
|
56.60 Days
Standard Deviation 12.49
|
57.65 Days
Standard Deviation 8.80
|
PRIMARY outcome
Timeframe: Maximum of 16 weeksPopulation: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Outcome measures
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=193 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Specialized Hospitals Only)
n=120 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Extramural Infusion Centers Only)
n=73 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
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|---|---|---|---|
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Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 3/4 (n=193, n=120, n=73)
|
57.00 Days
Interval 25.0 to 135.0
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57.00 Days
Interval 29.0 to 85.0
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57.00 Days
Interval 25.0 to 135.0
|
|
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 4/5 (n=193, n=120, n=73)
|
57.00 Days
Interval 41.0 to 120.0
|
57.00 Days
Interval 41.0 to 116.0
|
57.00 Days
Interval 43.0 to 120.0
|
|
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 5/6 (n=178, n=110, n=68)
|
57.00 Days
Interval 30.0 to 140.0
|
57.00 Days
Interval 30.0 to 140.0
|
57.00 Days
Interval 42.0 to 71.0
|
|
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 6/7 (n=163, n=99, n-64)
|
57.00 Days
Interval 30.0 to 106.0
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57.00 Days
Interval 41.0 to 92.0
|
57.00 Days
Interval 30.0 to 106.0
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|
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 7/8 (n=153, n=91, n=62)
|
57.00 Days
Interval 13.0 to 112.0
|
57.00 Days
Interval 13.0 to 97.0
|
57.00 Days
Interval 44.0 to 112.0
|
|
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 8/9 (n=143, n=83, n=60)
|
57.00 Days
Interval 24.0 to 113.0
|
57.00 Days
Interval 24.0 to 113.0
|
57.00 Days
Interval 43.0 to 111.0
|
PRIMARY outcome
Timeframe: Maximum of 102 weeksPopulation: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Outcome measures
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=193 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Specialized Hospitals Only)
n=120 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Extramural Infusion Centers Only)
n=73 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
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|---|---|---|---|
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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 1 (n=193, n=120, n=73)
|
3.42 milligrams/kilograms (mg/kg)
Standard Deviation 0.59
|
3.50 milligrams/kilograms (mg/kg)
Standard Deviation 0.59
|
3.30 milligrams/kilograms (mg/kg)
Standard Deviation 0.56
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|
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 2 (n=192, n=119, n=73)
|
3.43 milligrams/kilograms (mg/kg)
Standard Deviation 0.59
|
3.51 milligrams/kilograms (mg/kg)
Standard Deviation 0.59
|
3.31 milligrams/kilograms (mg/kg)
Standard Deviation 0.56
|
|
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 3 (n=193, n=120, n=73)
|
3.46 milligrams/kilograms (mg/kg)
Standard Deviation 0.62
|
3.56 milligrams/kilograms (mg/kg)
Standard Deviation 0.65
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3.30 milligrams/kilograms (mg/kg)
Standard Deviation 0.54
|
|
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 4 (n=193, n=120, n=73)
|
3.50 milligrams/kilograms (mg/kg)
Standard Deviation 0.62
|
3.59 milligrams/kilograms (mg/kg)
Standard Deviation 0.63
|
3.36 milligrams/kilograms (mg/kg)
Standard Deviation 0.57
|
|
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 5 (n=193, n=120, n=73)
|
3.53 milligrams/kilograms (mg/kg)
Standard Deviation 0.67
|
3.62 milligrams/kilograms (mg/kg)
Standard Deviation 0.71
|
3.36 milligrams/kilograms (mg/kg)
Standard Deviation 0.58
|
|
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 6 (n=178, n=110, n=68)
|
3.56 milligrams/kilograms (mg/kg)
Standard Deviation 0.70
|
3.70 milligrams/kilograms (mg/kg)
Standard Deviation 0.75
|
3.34 milligrams/kilograms (mg/kg)
Standard Deviation 0.54
|
|
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 7 (n=163, n=99, n=64)
|
3.63 milligrams/kilograms (mg/kg)
Standard Deviation 0.74
|
3.78 milligrams/kilograms (mg/kg)
Standard Deviation 0.82
|
3.39 milligrams/kilograms (mg/kg)
Standard Deviation 0.53
|
|
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 8 (n=153, n=91, n=62)
|
3.60 milligrams/kilograms (mg/kg)
Standard Deviation 0.72
|
3.75 milligrams/kilograms (mg/kg)
Standard Deviation 0.79
|
3.37 milligrams/kilograms (mg/kg)
Standard Deviation 0.53
|
|
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 9 (n=143, n=83, n=60)
|
3.61 milligrams/kilograms (mg/kg)
Standard Deviation 0.72
|
3.79 milligrams/kilograms (mg/kg)
Standard Deviation 0.78
|
3.36 milligrams/kilograms (mg/kg)
Standard Deviation 0.54
|
PRIMARY outcome
Timeframe: Maximum of 102 weeksPopulation: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Outcome measures
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=193 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Specialized Hospitals Only)
n=120 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Extramural Infusion Centers Only)
n=73 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
|---|---|---|---|
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Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 8 (n=153, n=91, n=62)
|
3.53 mg/kg
Interval 2.13 to 5.71
|
3.70 mg/kg
Interval 2.13 to 5.56
|
3.33 mg/kg
Interval 2.5 to 5.71
|
|
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 1 (n=193, n=120, n=73)
|
3.33 mg/kg
Interval 2.25 to 6.15
|
3.38 mg/kg
Interval 2.45 to 5.97
|
3.23 mg/kg
Interval 2.25 to 6.15
|
|
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 2 (n=192, n=119, n=73)
|
3.33 mg/kg
Interval 2.25 to 6.15
|
3.39 mg/kg
Interval 2.56 to 5.97
|
3.23 mg/kg
Interval 2.25 to 6.15
|
|
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 3 (n=193, n=120, n=73)
|
3.33 mg/kg
Interval 2.22 to 5.97
|
3.40 mg/kg
Interval 2.22 to 5.88
|
3.23 mg/kg
Interval 2.41 to 5.97
|
|
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 4 (n=193, n=120, n=73)
|
3.41 mg/kg
Interval 2.44 to 5.8
|
3.49 mg/kg
Interval 2.5 to 5.8
|
3.33 mg/kg
Interval 2.44 to 5.8
|
|
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 5 (n=193, n=120, n=73)
|
3.39 mg/kg
Interval 2.08 to 5.71
|
3.53 mg/kg
Interval 2.08 to 5.48
|
3.33 mg/kg
Interval 2.35 to 5.71
|
|
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 6 (n=178, n=110, n=68)
|
3.41 mg/kg
Interval 2.13 to 5.71
|
3.61 mg/kg
Interval 2.13 to 5.48
|
3.33 mg/kg
Interval 2.35 to 5.71
|
|
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 7 (n=163, n=99, n=64)
|
3.53 mg/kg
Interval 2.13 to 5.71
|
3.70 mg/kg
Interval 2.13 to 5.66
|
3.33 mg/kg
Interval 2.56 to 5.71
|
|
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 9 (n=143, n=83, n=60)
|
3.53 mg/kg
Interval 2.38 to 5.71
|
3.70 mg/kg
Interval 2.43 to 5.56
|
3.33 mg/kg
Interval 2.38 to 5.71
|
PRIMARY outcome
Timeframe: Maximum of 102 weeksPopulation: Remicade-naive participants who were exposed to Remicade during the observational study.
Outcome measures
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=500 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Specialized Hospitals Only)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Extramural Infusion Centers Only)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
|---|---|---|---|
|
Mean Remicade Dose Per Participant
|
3.56 mg/kg
Standard Deviation 0.63
|
—
|
—
|
PRIMARY outcome
Timeframe: Maximum of 102 weeksPopulation: Remicade-naive participants who were exposed to Remicade during the observational study.
Outcome measures
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=500 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Specialized Hospitals Only)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Extramural Infusion Centers Only)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
|---|---|---|---|
|
Median Remicade Dose Per Participant
|
3.49 mg/kg
Interval 2.08 to 5.85
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 months maximumPopulation: Remicade-naive participants who were exposed to Remicade during the observational study.
Outcome measures
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=511 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Specialized Hospitals Only)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Extramural Infusion Centers Only)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
|---|---|---|---|
|
Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy
|
8.02 Years
Standard Deviation 8.07
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 months maximumPopulation: Remicade-naive participants who were exposed to Remicade during the observational study.
Some participants had more than one previous treatment with a DMARD.
Outcome measures
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=516 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Specialized Hospitals Only)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Extramural Infusion Centers Only)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
|---|---|---|---|
|
Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Methotrexate
|
470 Participants
|
—
|
—
|
|
Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Sulfasalazine
|
111 Participants
|
—
|
—
|
|
Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Leflunomide
|
138 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 months maximumPopulation: Remicade-naive participants with available data.
Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS \& the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Outcome measures
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=194 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Specialized Hospitals Only)
n=121 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Extramural Infusion Centers Only)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
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|---|---|---|---|
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Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)
Baseline (n=194, n=121)
|
31.25 Score on a scale
Standard Deviation 15.78
|
31.59 Score on a scale
Standard Deviation 16.81
|
—
|
|
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)
Endpoint (after 9 infusions; n=125, n=13))
|
58.96 Score on a scale
Standard Deviation 22.26
|
42.46 Score on a scale
Standard Deviation 20.78
|
—
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SECONDARY outcome
Timeframe: 24 months maximumPopulation: Remicade-naive participants with available data.
Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS \& the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Outcome measures
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=194 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Specialized Hospitals Only)
n=124 Participants
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
Remicade (Extramural Infusion Centers Only)
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
|---|---|---|---|
|
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS
Baseline (n=194, n=124)
|
43.89 Score on a scale
Standard Deviation 17.98
|
45.12 Score on a scale
Standard Deviation 18.70
|
—
|
|
Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS
Endpoint (after 9 infusions; n=125, n=13)
|
67.10 Score on a scale
Standard Deviation 20.96
|
46.18 Score on a scale
Standard Deviation 25.71
|
—
|
Adverse Events
Remicade (Specialized Hospitals & Extramural Infusion Centers)
Serious events: 21 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Remicade (Specialized Hospitals & Extramural Infusion Centers)
n=516 participants at risk
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
|
|---|---|
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Blood and lymphatic system disorders
Hypochromic anaemia
|
0.19%
1/516 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.19%
1/516 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.19%
1/516 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness
|
0.19%
1/516 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
0.19%
1/516 • Number of events 1
|
|
General disorders
Infusion related reaction
|
0.19%
1/516 • Number of events 1
|
|
Gastrointestinal disorders
Multi-organ failure
|
0.19%
1/516 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.19%
1/516 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.19%
1/516 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.39%
2/516 • Number of events 2
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.19%
1/516 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.19%
1/516 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.19%
1/516 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.19%
1/516 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.19%
1/516 • Number of events 1
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.19%
1/516 • Number of events 1
|
|
Surgical and medical procedures
Hospitalisation
|
0.39%
2/516 • Number of events 2
|
|
Surgical and medical procedures
Knee operation
|
0.19%
1/516 • Number of events 1
|
|
Surgical and medical procedures
Wrist surgery
|
0.19%
1/516 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.19%
1/516 • Number of events 1
|
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