Trial Outcomes & Findings for Investigation of 9 Consecutive Infusions of Remicade for Psoriatic Arthritis in Austria (Study P04264) (NCT NCT00725296)
NCT ID: NCT00725296
Last Updated: 2015-11-05
Results Overview
The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Recruitment status
COMPLETED
Target enrollment
178 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2015-11-05
Participant Flow
A total of 178 participants were enrolled in this study. Of these, 159 participants were Infliximab-naive and 19 participants were already on Remicade (Infliximab). A total of 163 participants received at least one dose: 152 of the 159 naive participants and 11 of the 19 non-naive participants.
Participant milestones
| Measure |
Infliximab
Participants with active and progressive psoriatic arthritis (PsA) who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
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|---|---|
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Overall Study
STARTED
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163
|
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Overall Study
COMPLETED
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101
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Overall Study
NOT COMPLETED
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62
|
Reasons for withdrawal
| Measure |
Infliximab
Participants with active and progressive psoriatic arthritis (PsA) who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
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|---|---|
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Overall Study
Adverse Event
|
11
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Overall Study
Lack of Efficacy
|
7
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Overall Study
Withdrawal by Subject
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3
|
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Overall Study
Non-Compliance
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Other
|
38
|
Baseline Characteristics
Investigation of 9 Consecutive Infusions of Remicade for Psoriatic Arthritis in Austria (Study P04264)
Baseline characteristics by cohort
| Measure |
Infliximab
n=163 Participants
Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
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|---|---|
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Age, Continuous
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47.96 years
STANDARD_DEVIATION 13.22 • n=5 Participants
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Sex: Female, Male
Female
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62 Participants
n=5 Participants
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Sex: Female, Male
Male
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101 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: N= number of Infliximab-naive participants that received induction \& maintenance therapy. Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions).
The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Outcome measures
| Measure |
Infliximab
n=83 Participants
Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
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|---|---|
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Mean Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 3/4 (n= 83)
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57.03 days
Standard Deviation 7.83
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Mean Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 4/5 (n=83)
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57.90 days
Standard Deviation 7.97
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Mean Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 5/6 (n=79)
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58.59 days
Standard Deviation 12.28
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Mean Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 6/7 (n=77)
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56.02 days
Standard Deviation 10.59
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Mean Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 7/8 (n=73)
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56.92 days
Standard Deviation 10.76
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Mean Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 8/9 (n=70)
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59.32 days
Standard Deviation 18.39
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PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: N= number of Infliximab-naive participants that received induction \& maintenance therapy. Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions).
The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Outcome measures
| Measure |
Infliximab
n=83 Participants
Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
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|---|---|
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Median Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 3/4 (n= 83)
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56 days
Interval 36.0 to 84.0
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Median Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 4/5 (n=83)
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56 days
Interval 41.0 to 84.0
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Median Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 5/6 (n=79)
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56 days
Interval 30.0 to 114.0
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Median Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 6/7 (n=77)
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56 days
Interval 33.0 to 115.0
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|
Median Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 7/8 (n=73)
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56 days
Interval 35.0 to 119.0
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Median Time Interval Between Infusions During Maintenance Therapy
Interval between infusion 8/9 (n=70)
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56 days
Interval 35.0 to 159.0
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PRIMARY outcome
Timeframe: Up to 24 MonthsPopulation: N= number of Infliximab-naive participants that received induction \& maintenance therapy. Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions).
The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
Outcome measures
| Measure |
Infliximab
n=83 Participants
Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
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|---|---|
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Average Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 1 (n=83)
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3.92 mg/kg
Standard Deviation 0.80
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Average Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 2 (n=83)
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3.92 mg/kg
Standard Deviation 0.81
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Average Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 3 (n=83)
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3.98 mg/kg
Standard Deviation 0.86
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Average Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 4 (n=83)
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3.96 mg/kg
Standard Deviation 0.87
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Average Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 5 (n=83)
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3.94 mg/kg
Standard Deviation 0.85
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Average Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 6 (n=79)
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3.94 mg/kg
Standard Deviation 0.85
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Average Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 7 (n=77)
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3.97 mg/kg
Standard Deviation 0.84
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Average Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 8 (n=73)
|
3.97 mg/kg
Standard Deviation 0.87
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Average Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 9 (n=70)
|
3.97 mg/kg
Standard Deviation 0.89
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PRIMARY outcome
Timeframe: Up to 24 MonthsPopulation: N= number of Infliximab-naive participants that received induction \& maintenance therapy. Out of 152 Infliximab-naive participants who were treated, 94 participants received induction therapy (Infliximab at weeks 0, 2, and 6), 83 participants received induction therapy and subsequent maintenance therapy (maximum of 6 maintenance infusions).
The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
Outcome measures
| Measure |
Infliximab
n=83 Participants
Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
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|---|---|
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Median Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 1 (n=83)
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3.75 mg/kg
Interval 2.7 to 5.71
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Median Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 2 (n=83)
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3.75 mg/kg
Interval 2.7 to 5.71
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|
Median Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 3 (n=83)
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3.75 mg/kg
Interval 2.67 to 5.71
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Median Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 4 (n=83)
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3.75 mg/kg
Interval 2.67 to 5.71
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|
Median Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 5 (n=83)
|
3.75 mg/kg
Interval 2.67 to 5.56
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|
Median Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 6 (n=79)
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3.75 mg/kg
Interval 2.67 to 5.56
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|
Median Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 7 (n=77)
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3.75 mg/kg
Interval 2.67 to 5.56
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|
Median Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 8 (n=73)
|
3.75 mg/kg
Interval 2.63 to 5.63
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Median Dose During Induction Therapy and Subsequent Maintenance Therapy
Infusion 9 (n=70)
|
3.75 mg/kg
Interval 2.67 to 5.63
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PRIMARY outcome
Timeframe: Up to 24 MonthsPopulation: 152 out of the 159 Infliximab-naive participants were treated in the active phase.
The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.
Outcome measures
| Measure |
Infliximab
n=152 Participants
Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
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|---|---|
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Average Overall Dose of All Infusions Per Participant
|
4.07 mg/kg
Standard Deviation 0.84
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PRIMARY outcome
Timeframe: Up to 24 MonthsPopulation: 152 out of the 159 Infliximab-naive participants were treated in the active phase.
The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.
Outcome measures
| Measure |
Infliximab
n=152 Participants
Participants with active and progressive psoriatic PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
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|---|---|
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Median Dose of All Infusions Per Participant
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3.87 mg/kg
Interval 2.53 to 6.41
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Adverse Events
Infliximab
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infliximab
n=163 participants at risk
Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs received induction intravenous (IV) infusions of Infliximab at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians and in the usual manner in accordance to the term of the applicable marketing authorization. Then, a maximum of 6 maintenance infusions were administered with the dosage and interval due to the discretion of the physicians. According to the European Summary of Product Characteristics (SPC), Infliximab 5 mg/kg is given as an IV infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
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|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.61%
1/163 • Number of events 1
A total of 163 participants out of the 178 enrolled received at least one dose: 152 of the 159 naive participants and 11 of the 19 non-naive participants. Adverse events (AEs) were collected for participants who had received at least one dose of Infliximab.
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|
General disorders
Pain
|
1.2%
2/163 • Number of events 2
A total of 163 participants out of the 178 enrolled received at least one dose: 152 of the 159 naive participants and 11 of the 19 non-naive participants. Adverse events (AEs) were collected for participants who had received at least one dose of Infliximab.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
0.61%
1/163 • Number of events 1
A total of 163 participants out of the 178 enrolled received at least one dose: 152 of the 159 naive participants and 11 of the 19 non-naive participants. Adverse events (AEs) were collected for participants who had received at least one dose of Infliximab.
|
|
Nervous system disorders
Demyelinating Polyneuropathy
|
0.61%
1/163 • Number of events 1
A total of 163 participants out of the 178 enrolled received at least one dose: 152 of the 159 naive participants and 11 of the 19 non-naive participants. Adverse events (AEs) were collected for participants who had received at least one dose of Infliximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.61%
1/163 • Number of events 1
A total of 163 participants out of the 178 enrolled received at least one dose: 152 of the 159 naive participants and 11 of the 19 non-naive participants. Adverse events (AEs) were collected for participants who had received at least one dose of Infliximab.
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.61%
1/163 • Number of events 1
A total of 163 participants out of the 178 enrolled received at least one dose: 152 of the 159 naive participants and 11 of the 19 non-naive participants. Adverse events (AEs) were collected for participants who had received at least one dose of Infliximab.
|
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