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| Name | Class |
|---|---|
| Centocor, Inc. | INDUSTRY |
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This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).
This study population was chosen from a non-probability sample.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remicade (Infliximab) | Participants with active and progressive PsA who have responded inadequately to disease-modifying anti-rheumatic drugs will receive induction infusions of Remicade at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians. Whole observation period cannot exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in the Summary of Product Characteristics (SPC) is taken into consideration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remicade (Infliximab) | Biological | Induction infusions of Remicade will be administered at weeks 0, 2, and 6 given in a dosage due to the decision of the physicians. A maximum of 6 maintenance infusions will be administered with the dosage and interval due to the discretion of the physicians. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time Interval Between Infusions During Maintenance Therapy | 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. | Up to 24 months |
| Median Time Interval Between Infusions During Maintenance Therapy | 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. | Up to 24 months |
| Average Dose During Induction Therapy and Subsequent Maintenance Therapy | 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). | Up to 24 Months |
| Median Dose During Induction Therapy and Subsequent Maintenance Therapy | 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). | Up to 24 Months |
| Average Overall Dose of All Infusions Per Participant | The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg. | Up to 24 Months |
| Median Dose of All Infusions Per Participant |
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Inclusion Criteria:
Exclusion Criteria:
All according to contraindications in the label especially:
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Participants will receive Remicade induction therapy consisting of 3 infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to the discretion of physicians.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age of participants was assessed in 163 out of 178 enrolled participants. A total of 163 participants received at least one dose of Infliximab. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Time Interval Between Infusions During Maintenance Therapy | 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. | 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). | Posted | Mean | Standard Deviation | days | Up to 24 months |
|
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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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infliximab | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
|
The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.
| Up to 24 Months |
| Non-Compliance |
|
| Lost to Follow-up |
|
| Other |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Median Time Interval Between Infusions During Maintenance Therapy | 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. | 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). | Posted | Median | Full Range | days | Up to 24 months |
|
|
|
| Primary | Average Dose During Induction Therapy and Subsequent Maintenance Therapy | 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). | 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). | Posted | Mean | Standard Deviation | mg/kg | Up to 24 Months |
|
|
|
| Primary | Median Dose During Induction Therapy and Subsequent Maintenance Therapy | 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). | 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). | Posted | Median | Full Range | mg/kg | Up to 24 Months |
|
|
|
| Primary | Average Overall Dose of All Infusions Per Participant | The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg. | 152 out of the 159 Infliximab-naive participants were treated in the active phase. | Posted | Mean | Standard Deviation | mg/kg | Up to 24 Months |
|
|
|
| Primary | Median Dose of All Infusions Per Participant | The median dose of all infusions among all Infliximab-naive participants measured in mg/kg. | 152 out of the 159 Infliximab-naive participants were treated in the active phase. | Posted | Median | Full Range | mg/kg | Up to 24 Months |
|
|
|
| 6 |
| 163 |
| 0 |
| 163 |
| Pain | General disorders | MedDRA (13.1) |
|
| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (13.1) |
|
| Demyelinating Polyneuropathy | Nervous system disorders | MedDRA (13.1) |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) |
|
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDRA (13.1) |
|
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| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Interval between infusion 6/7 (n=77) |
|
| Interval between infusion 7/8 (n=73) |
|
| Interval between infusion 8/9 (n=70) |
|
| Title | Measurements |
|---|---|
|
| Infusion 4 (n=83) |
|
| Infusion 5 (n=83) |
|
| Infusion 6 (n=79) |
|
| Infusion 7 (n=77) |
|
| Infusion 8 (n=73) |
|
| Infusion 9 (n=70) |
|
| Title | Measurements |
|---|---|
|
| Infusion 4 (n=83) |
|
| Infusion 5 (n=83) |
|
| Infusion 6 (n=79) |
|
| Infusion 7 (n=77) |
|
| Infusion 8 (n=73) |
|
| Infusion 9 (n=70) |
|