Trial Outcomes & Findings for Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900) (NCT NCT00725452)
NCT ID: NCT00725452
Last Updated: 2015-07-28
Results Overview
The types of therapies were assessed according to the following criteria: Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days). Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks). Episodic Therapy: given out of time frame (\> 12 weeks).
Recruitment status
COMPLETED
Target enrollment
26 participants
Primary outcome timeframe
Maximum 2 years
Results posted on
2015-07-28
Participant Flow
Participant milestones
| Measure |
Infliximab
Infliximab 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 the physician.
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|---|---|
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Overall Study
STARTED
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26
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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11
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Reasons for withdrawal
| Measure |
Infliximab
Infliximab 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 the physician.
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Overall Study
Adverse Event
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3
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Overall Study
Lack of Efficacy
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2
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Overall Study
Reason not specified
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1
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Overall Study
Physician Decision
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1
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Overall Study
Withdrawal by Subject
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3
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Five-Year Observation of Remicade Treatment for Plaque Psoriasis in Austria (Study P04900)
Baseline characteristics by cohort
| Measure |
Infliximab
n=26 Participants
Infliximab 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 the physician.
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Age, Continuous
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46.23 years
STANDARD_DEVIATION 10.17 • n=5 Participants
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Sex: Female, Male
Female
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7 Participants
n=5 Participants
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Sex: Female, Male
Male
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19 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Maximum 2 yearsPopulation: Infliximab-naive participants who received Infliximab during the study.
The types of therapies were assessed according to the following criteria: Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days). Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks). Episodic Therapy: given out of time frame (\> 12 weeks).
Outcome measures
| Measure |
Infliximab
n=12 Participants
Infliximab 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 the physician.
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Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab
Induction therapy
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7 Therapies
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Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab
Maintenance therapy
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2 Therapies
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Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab
Episodic therapy
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1 Therapies
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Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab
No treatment regimen applied
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2 Therapies
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SECONDARY outcome
Timeframe: Maximum 2 yearsPopulation: Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.
Outcome measures
| Measure |
Infliximab
n=4 Participants
Infliximab 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 the physician.
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Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 3 and 4 (n=4)
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49.25 Days
Standard Deviation 13.50
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Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 4 and 5 (n=4)
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57.25 Days
Standard Deviation 2.50
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Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 5 and 6 (n=3)
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59.67 Days
Standard Deviation 8.14
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Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 6 and 7 (n=3)
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55.00 Days
Standard Deviation 3.61
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Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 7 and 8 (n=3)
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56.00 Days
Standard Deviation 0
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Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 8 and 9 (n=2)
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55.50 Days
Standard Deviation 2.12
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SECONDARY outcome
Timeframe: Maximum 2 yearsPopulation: Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab.
Outcome measures
| Measure |
Infliximab
n=4 Participants
Infliximab 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 the physician.
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Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 3 and 4 (n=4)
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56.00 Days
Interval 29.0 to 56.0
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Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 4 and 5 (n=4)
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56.00 Days
Interval 56.0 to 61.0
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Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 5 and 6 (n=3)
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56.00 Days
Interval 54.0 to 69.0
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Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 6 and 7 (n=3)
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56.00 Days
Interval 51.0 to 58.0
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Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 7 and 8 (n=3)
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56.00 Days
Interval 56.0 to 56.0
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Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy
Between Infusion 8 and 9 (n=2)
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55.50 Days
Interval 54.0 to 57.0
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SECONDARY outcome
Timeframe: Maximum 2 yearsPopulation: All participants who received at least 1 Infliximab infusion during the observational phase.
Outcome measures
| Measure |
Infliximab
n=26 Participants
Infliximab 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 the physician.
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Mean Dose of Infliximab
Infusion 1 (n=26)
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4.55 milligrams/kilograms (mg/kg)
Standard Deviation 0.85
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Mean Dose of Infliximab
Infusion 2 (n=23)
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4.66 milligrams/kilograms (mg/kg)
Standard Deviation 0.89
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Mean Dose of Infliximab
Infusion 3 (n=23)
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4.67 milligrams/kilograms (mg/kg)
Standard Deviation 0.93
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Mean Dose of Infliximab
Infusion 4 (n=21)
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4.58 milligrams/kilograms (mg/kg)
Standard Deviation 0.97
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Mean Dose of Infliximab
Infusion 5 (n=18)
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4.51 milligrams/kilograms (mg/kg)
Standard Deviation 0.89
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Mean Dose of Infliximab
Infusion 6 (n=16)
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4.41 milligrams/kilograms (mg/kg)
Standard Deviation 0.91
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Mean Dose of Infliximab
Infusion 7 (n=16)
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4.44 milligrams/kilograms (mg/kg)
Standard Deviation 0.91
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Mean Dose of Infliximab
Infusion 8 (n=16)
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4.16 milligrams/kilograms (mg/kg)
Standard Deviation 1.02
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Mean Dose of Infliximab
Infusion 9 (n=14)
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4.30 milligrams/kilograms (mg/kg)
Standard Deviation 1.06
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SECONDARY outcome
Timeframe: Maximum 2 yearsPopulation: All participants who received at least 1 Infliximab infusion during the observational phase.
Outcome measures
| Measure |
Infliximab
n=26 Participants
Infliximab 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 the physician.
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Median Dose of Infliximab
Infusion 4 (n=21)
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5.00 mg/kg
Interval 2.61 to 5.41
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Median Dose of Infliximab
Infusion 5 (n=18)
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4.91 mg/kg
Interval 2.95 to 5.23
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Median Dose of Infliximab
Infusion 1 (n=26)
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4.88 mg/kg
Interval 2.73 to 5.31
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Median Dose of Infliximab
Infusion 2 (n=23)
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5.00 mg/kg
Interval 2.68 to 5.48
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Median Dose of Infliximab
Infusion 3 (n=23)
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5.00 mg/kg
Interval 2.61 to 5.56
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Median Dose of Infliximab
Infusion 6 (n=16)
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4.71 mg/kg
Interval 2.98 to 5.3
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Median Dose of Infliximab
Infusion 7 (n=16)
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4.94 mg/kg
Interval 2.98 to 5.06
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Median Dose of Infliximab
Infusion 8 (n=16)
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4.68 mg/kg
Interval 2.86 to 5.06
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Median Dose of Infliximab
Infusion 9 (n=14)
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4.94 mg/kg
Interval 2.86 to 5.06
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SECONDARY outcome
Timeframe: Baseline and Infusion 9Population: Infliximab-naive participants who received Infliximab during the study.
BSA estimation was determined using the participant's handprint (palmar surface of palms plus five digits). The number of handprints that covered the affected skin area was counted. One handprint was approximately equivalent to 1 percent of the BSA; therefore, BSA was calculated in percentages. The change from Baseline in BSA was calculated by subtracting Baseline from infusion 9.
Outcome measures
| Measure |
Infliximab
n=8 Participants
Infliximab 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 the physician.
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Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab
Baseline
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38.63 Percent of BSA involved with psoriasis
Standard Deviation 25.63
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Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab
Change from Baseline after Infusion 9
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-11.17 Percent of BSA involved with psoriasis
Standard Deviation 21.22
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Adverse Events
Infliximab
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infliximab
n=26 participants at risk
Infliximab 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 the physician.
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|---|---|
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Skin and subcutaneous tissue disorders
Psoriasis
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3.8%
1/26 • Number of events 1
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Surgical and medical procedures
Hospitalisation
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3.8%
1/26 • Number of events 1
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Other adverse events
| Measure |
Infliximab
n=26 participants at risk
Infliximab 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 the physician.
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Infections and infestations
Pharyngitis
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7.7%
2/26 • Number of events 2
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Musculoskeletal and connective tissue disorders
Arthralgia
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7.7%
2/26 • Number of events 2
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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