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| Name | Class |
|---|---|
| Centocor, Inc. | INDUSTRY |
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Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and interval of Infliximab infusions for subjects with plaque psoriasis.
This study population was chosen from a non-probability sample.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab | Subjects with plaque psoriasis will receive Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers. A maximum of 6 maintenance infusions will be given in doses and intervals due to the discretion of the physicians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Infliximab initial induction therapy consisting of 3 Infliximab infusions at weeks 0, 2, and 6 given in specialized centers. A maximum of 6 maintenance infusions will be given in doses and intervals due to the discretion of the physicians. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab | 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). | Maximum 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Maximum 2 years | |
| Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Maximum 2 years |
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Inclusion Criteria:
Exclusion Criteria:
According to the European SPC:
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Adult subjects with moderate-to-severe plaque psoriasis will receive Infliximab induction therapy in specialized centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab | 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). | Infliximab-naive participants who received Infliximab during the study. | Posted | Number | Therapies | Maximum 2 years |
|
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (13.1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngitis | Infections and infestations | MedDRA (13.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| Mean Dose of Infliximab | Maximum 2 years |
| Median Dose of Infliximab | Maximum 2 years |
| Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab | 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. | Baseline and Infusion 9 |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab. | Posted | Mean | Standard Deviation | Days | Maximum 2 years |
|
|
|
| Secondary | Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy | Infliximab-naive participants who received induction therapy and subsequent maintenance therapy with Infliximab. | Posted | Mean | Full Range | Days | Maximum 2 years |
|
|
|
| Secondary | Mean Dose of Infliximab | All participants who received at least 1 Infliximab infusion during the observational phase. | Posted | Mean | Standard Deviation | milligrams/kilograms (mg/kg) | Maximum 2 years |
|
|
|
| Secondary | Median Dose of Infliximab | All participants who received at least 1 Infliximab infusion during the observational phase. | Posted | Median | Full Range | mg/kg | Maximum 2 years |
|
|
|
| Secondary | Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab | 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. | Infliximab-naive participants who received Infliximab during the study. | Posted | Mean | Standard Deviation | Percent of BSA involved with psoriasis | Baseline and Infusion 9 |
|
|
|
| 2 |
| 26 |
| 4 |
| 26 |
| Hospitalisation | Surgical and medical procedures | MedDRA (13.1) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) |
|
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Between Infusion 6 and 7 (n=3) |
|
| Between Infusion 7 and 8 (n=3) |
|
| Between Infusion 8 and 9 (n=2) |
|
| Title | Measurements |
|---|---|
|
| Between Infusion 6 and 7 (n=3) |
|
| Between Infusion 7 and 8 (n=3) |
|
| Between Infusion 8 and 9 (n=2) |
|
| Title | Measurements |
|---|
|
| Infusion 4 (n=21) |
|
| Infusion 5 (n=18) |
|
| Infusion 6 (n=16) |
|
| Infusion 7 (n=16) |
|
| Infusion 8 (n=16) |
|
| Infusion 9 (n=14) |
|
| Title | Measurements |
|---|
|
| Infusion 4 (n=21) |
|
| Infusion 5 (n=18) |
|
| Infusion 6 (n=16) |
|
| Infusion 7 (n=16) |
|
| Infusion 8 (n=16) |
|
| Infusion 9 (n=14) |
|