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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 average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)
This study population was chosen from a non-probability sample.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remicade | Patients with severe RA (indication according to Austrian labeling) will receive Remicade induction therapy consisting of three Remicade infusions in weeks 0, 2, and 6 given in specialized centers. Maintenance therapy will consist of another maximal 6 infusions. Remicade induction and maintenance therapy doses and intervals will be at the discretion of the physicians. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Remicade induction therapy consisting of three 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 16 weeks |
| Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 16 weeks |
| Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 102 weeks |
| Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Maximum of 102 weeks |
| Mean Remicade Dose Per Participant | Maximum of 102 weeks | |
| Median Remicade Dose Per Participant | Maximum of 102 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy | 24 months maximum | |
| Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | Some participants had more than one previous treatment with a DMARD. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with severe RA being treated at specialized centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Remicade (Specialized Hospitals & Extramural Infusion Centers) | Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 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 (Specialized Hospitals & Extramural Infusion Centers) | Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 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 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 | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study. | Posted | Mean | Standard Deviation | Days | Maximum of 16 weeks |
|
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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 (Specialized Hospitals & Extramural Infusion Centers) | Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 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 SPC was taken into consideration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypochromic anaemia | 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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|
| 24 months maximum |
| Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) | Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | 24 months maximum |
| Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS | Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | 24 months maximum |
| Physician Decision |
|
| Lost to Follow-up |
|
| Non-compliance |
|
| Continued treatment by other physician |
|
| Switched to other study |
|
| Switched to other drug |
|
| Prepared for elective surgery |
|
| Reason not specified |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Remicade (Specialized Hospitals Only) | Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 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 SPC was taken into consideration. |
| OG002 | Remicade (Extramural Infusion Centers Only) | Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 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 SPC was taken into consideration. |
|
|
| Primary | Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study. | Posted | Median | Full Range | Days | Maximum of 16 weeks |
|
|
|
| Primary | Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | 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 102 weeks |
|
|
|
| Secondary | Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy | Remicade-naive participants who were exposed to Remicade during the observational study. | Posted | Mean | Standard Deviation | Years | 24 months maximum |
|
|
|
| Secondary | Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) | Some participants had more than one previous treatment with a DMARD. | Remicade-naive participants who were exposed to Remicade during the observational study. | Posted | Number | Participants | 24 months maximum |
|
|
|
| Primary | Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy | The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study. | Posted | Median | Full Range | mg/kg | Maximum of 102 weeks |
|
|
|
| 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 102 weeks |
|
|
|
| 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 102 weeks |
|
|
|
| Secondary | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS) | Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Remicade-naive participants with available data. | Posted | Mean | Standard Deviation | Score on a scale | 24 months maximum |
|
|
|
| Secondary | Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS | Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined. | Remicade-naive participants with available data. | Posted | Mean | Standard Deviation | Score on a scale | 24 months maximum |
|
|
|
| 21 |
| 516 |
| 0 |
| 516 |
| Angina pectoris | Cardiac disorders | MedDRA 13.1 |
|
| Tachycardia | Cardiac disorders | MedDRA 13.1 |
|
| Deafness | Ear and labyrinth disorders | MedDRA 13.1 |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.1 |
|
| Infusion related reaction | General disorders | MedDRA 13.1 |
|
| Multi-organ failure | Gastrointestinal disorders | MedDRA 13.1 |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.1 |
|
| Herpes zoster | Infections and infestations | MedDRA 13.1 |
|
| Pneumonia | Infections and infestations | MedDRA 13.1 |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
|
| Salivary gland adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 |
|
| Syncope | Nervous system disorders | MedDRA 13.1 |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 13.1 |
|
| Hospitalisation | Surgical and medical procedures | MedDRA 13.1 |
|
| Knee operation | Surgical and medical procedures | MedDRA 13.1 |
|
| Wrist surgery | Surgical and medical procedures | MedDRA 13.1 |
|
| Thrombosis | Vascular disorders | MedDRA 13.1 |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Infusion 4/5 (n=193, n=120, n=73) |
|
| Infusion 5/6 (n=178, n=110, n=68) |
|
| Infusion 6/7 (n=163, n=99, n-64) |
|
| Infusion 7/8 (n=153, n=91, n=62) |
|
| Infusion 8/9 (n=143, n=83, n=60) |
|
|
| Infusion 3 (n=193, n=120, n=73) |
|
| Infusion 4 (n=193, n=120, n=73) |
|
| Infusion 5 (n=193, n=120, n=73) |
|
| Infusion 6 (n=178, n=110, n=68) |
|
| Infusion 7 (n=163, n=99, n=64) |
|
| Infusion 8 (n=153, n=91, n=62) |
|
| Infusion 9 (n=143, n=83, n=60) |
|
| Title | Measurements |
|---|---|
|
|
| Infusion 3 (n=193, n=120, n=73) |
|
| Infusion 4 (n=193, n=120, n=73) |
|
| Infusion 5 (n=193, n=120, n=73) |
|
| Infusion 6 (n=178, n=110, n=68) |
|
| Infusion 7 (n=163, n=99, n=64) |
|
| Infusion 8 (n=153, n=91, n=62) |
|
| Infusion 9 (n=143, n=83, n=60) |
|