Trial Outcomes & Findings for Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED) (NCT NCT00725543)
NCT ID: NCT00725543
Last Updated: 2015-09-30
Results Overview
Recruitment status
COMPLETED
Target enrollment
358 participants
Primary outcome timeframe
Maximum of 24 months
Results posted on
2015-09-30
Participant Flow
Participant milestones
| Measure |
Remicade
Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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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358
|
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Overall Study
COMPLETED
|
205
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Overall Study
NOT COMPLETED
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153
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Reasons for withdrawal
| Measure |
Remicade
Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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
|
10
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Overall Study
Lack of Efficacy
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3
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Overall Study
Withdrawal by Subject
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10
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Overall Study
Physician Decision
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5
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Overall Study
Lost to Follow-up
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4
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Overall Study
Non-compliance
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2
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Overall Study
Other
|
119
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Baseline Characteristics
Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Remicade
n=358 Participants
Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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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Age, Continuous
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42.08 years
STANDARD_DEVIATION 11.81 • n=5 Participants
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Sex: Female, Male
Female
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98 Participants
n=5 Participants
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Sex: Female, Male
Male
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260 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Maximum of 24 monthsPopulation: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
Outcome measures
| Measure |
Remicade
n=165 Participants
Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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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Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 3/4 (n=165)
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56.10 Days
Standard Deviation 10.97
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Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 4/5 (n=165)
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60.62 Days
Standard Deviation 25.58
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Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 5/6 (n=159)
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57.91 Days
Standard Deviation 8.11
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Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 6/7 (n=154)
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59.39 Days
Standard Deviation 15.91
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Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 7/8 (n=152)
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59.52 Days
Standard Deviation 17.67
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Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 8/9 (n=143)
|
60.36 Days
Standard Deviation 17.96
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PRIMARY outcome
Timeframe: Maximum of 24 monthsPopulation: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
Outcome measures
| Measure |
Remicade
n=165 Participants
Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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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Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 3/4 (n=165)
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57.00 Days
Interval 26.0 to 141.0
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Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 4/5 (n=165)
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57.00 Days
Interval 19.0 to 340.0
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Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 5/6 (n=159)
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57.00 Days
Interval 15.0 to 84.0
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Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 6/7 (n=154)
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57.00 Days
Interval 29.0 to 176.0
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Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 7/8 (n=152)
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57.00 Days
Interval 42.0 to 211.0
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Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Infusion 8/9 (n=143)
|
57.00 Days
Interval 30.0 to 157.0
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PRIMARY outcome
Timeframe: Maximum of 24 months.Population: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
Outcome measures
| Measure |
Remicade
n=165 Participants
Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 1 (n=163)
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4.37 milligrams/kilograms (mg/kg)
Standard Deviation 0.93
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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 2 (n=164)
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4.39 milligrams/kilograms (mg/kg)
Standard Deviation 0.90
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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 3 (n=164)
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4.43 milligrams/kilograms (mg/kg)
Standard Deviation 0.88
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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 4 (n=165)
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4.42 milligrams/kilograms (mg/kg)
Standard Deviation 0.89
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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 5 (n=165)
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4.44 milligrams/kilograms (mg/kg)
Standard Deviation 0.87
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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 6 (n=160)
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4.47 milligrams/kilograms (mg/kg)
Standard Deviation 0.87
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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 7 (n=154)
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4.54 milligrams/kilograms (mg/kg)
Standard Deviation 0.91
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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 8 (n=152)
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4.59 milligrams/kilograms (mg/kg)
Standard Deviation 0.94
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Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 9 (n=143)
|
4.67 milligrams/kilograms (mg/kg)
Standard Deviation 0.93
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PRIMARY outcome
Timeframe: Maximum of 24 months.Population: Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
Outcome measures
| Measure |
Remicade
n=165 Participants
Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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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Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 1 (n=163)
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4.60 mg/kg
Interval 2.35 to 7.02
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Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 2 (n=164)
|
4.62 mg/kg
Interval 2.35 to 7.02
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Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 3 (n=164)
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4.62 mg/kg
Interval 2.38 to 7.02
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Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 4 (n=165)
|
4.62 mg/kg
Interval 2.32 to 7.02
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Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 5 (n=165)
|
4.62 mg/kg
Interval 2.44 to 7.02
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|
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 6 (n=160)
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4.66 mg/kg
Interval 2.44 to 7.02
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Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 7 (n=154)
|
4.68 mg/kg
Interval 2.41 to 7.69
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Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 8 (n=152)
|
4.71 mg/kg
Interval 2.35 to 7.69
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|
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Infusion 9 (n=143)
|
4.71 mg/kg
Interval 2.33 to 7.69
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PRIMARY outcome
Timeframe: Maximum of 24 monthsPopulation: Remicade-naive participants who were exposed to Remicade during the observational study.
Outcome measures
| Measure |
Remicade
n=348 Participants
Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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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Mean Remicade Dose Per Participant
|
4.53 mg/kg
Standard Deviation 0.84
|
PRIMARY outcome
Timeframe: Maximum of 24 monthsPopulation: Remicade-naive participants who were exposed to Remicade during the observational study.
Outcome measures
| Measure |
Remicade
n=348 Participants
Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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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Median Remicade Dose Per Participant
|
4.75 mg/kg
Interval 1.98 to 7.02
|
Adverse Events
Remicade
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Remicade
n=358 participants at risk
Remicade induction therapy consisted of 3 infusions (5 mg/kg) in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy consisted of a maximum of 6 infusions (5 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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Blood and lymphatic system disorders
Lymphadenopathy
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0.28%
1/358 • Number of events 1
|
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General disorders
Infusion Related Reaction
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0.28%
1/358 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
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0.28%
1/358 • Number of events 1
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|
Infections and infestations
Lymph Node Tuberculosis
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0.28%
1/358 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mixed Oligo-astrocytoma
|
0.28%
1/358 • Number of events 1
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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