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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 span of Remicade between infusions for ankylosing spondylitis (AS).
This study population was chosen from a non-probability sample.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remicade | Subjects with AS with severe axial symptoms and elevated serological markers of inflammatory activity will receive Remicade induction therapy consisting of 3 Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions given in doses and intervals due to discretion of physicians. Whole observation period cannot exceed 102 weeks per subject if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) is taken into consideration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Remicade induction therapy consists of 3 infusions given at weeks 0, 2, and 6 in specialized centers. Maintenance therapy will consist of a maximum of 6 infusions given in doses and intervals due to discretion of physicians. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Maximum of 24 months | |
| Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Maximum of 24 months | |
| Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Maximum of 24 months. | |
| Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Maximum of 24 months. | |
| Mean Remicade Dose Per Participant | Maximum of 24 months | |
| Median Remicade Dose Per Participant | Maximum of 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with AS will receive Remicade induction therapy at specialized centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study. | Posted | Mean | Standard Deviation | Days | Maximum of 24 months |
|
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system 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 |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| Physician Decision |
|
| Lost to Follow-up |
|
| Non-compliance |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study. | Posted | Median | Full Range | Days | Maximum of 24 months |
|
|
|
| Primary | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study. | Posted | Mean | Standard Deviation | milligrams/kilograms (mg/kg) | Maximum of 24 months. |
|
|
|
| Primary | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study. | Posted | Median | Full Range | mg/kg | Maximum of 24 months. |
|
|
|
| Primary | Mean Remicade Dose Per Participant | Remicade-naive participants who were exposed to Remicade during the observational study. | Posted | Mean | Standard Deviation | mg/kg | Maximum of 24 months |
|
|
|
| Primary | Median Remicade Dose Per Participant | Remicade-naive participants who were exposed to Remicade during the observational study. | Posted | Median | Full Range | mg/kg | Maximum of 24 months |
|
|
|
| 4 |
| 358 |
| 0 |
| 358 |
| Infusion Related Reaction | General disorders | MedDRA 13.1 |
|
| Hypersensitivity | Immune system disorders | MedDRA 13.1 |
|
| Lymph Node Tuberculosis | Infections and infestations | MedDRA 13.1 |
|
| Mixed Oligo-astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
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| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Infusion 6/7 (n=154) |
|
| Infusion 7/8 (n=152) |
|
| Infusion 8/9 (n=143) |
|
| Title | Measurements |
|---|---|
|
| Infusion 4 (n=165) |
|
| Infusion 5 (n=165) |
|
| Infusion 6 (n=160) |
|
| Infusion 7 (n=154) |
|
| Infusion 8 (n=152) |
|
| Infusion 9 (n=143) |
|
| Title | Measurements |
|---|---|
|
| Infusion 4 (n=165) |
|
| Infusion 5 (n=165) |
|
| Infusion 6 (n=160) |
|
| Infusion 7 (n=154) |
|
| Infusion 8 (n=152) |
|
| Infusion 9 (n=143) |
|