Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centocor, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.
This study population was chosen from a non-probability sample
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remicade | Subjects with active luminal and/or fistulizing CD in the hospital or non-hospital setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Biological | Not specified in the protocol. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). | up to 2 years |
| Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). | up to 2 years |
| Average Dose of Infliximab Per Participant Within the Observation Period | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). | up to 2 years |
| Median Dose of Infliximab Per Participant Within the Observation Period | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). | up to 2 years |
| Total Dose of Infliximab Per Participant Within the Observation Period | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; <5 (remission), 5-7 (mild disease), 8-16 (moderate disease), >16 (severe disease). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Subjects with active luminal and/or fistulizing CD who are treated with Remicade in the hospital and non-hospital setting.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Remicade | Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Remicade | Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting who received at least one infliximab infusion. |
| 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 Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). | n = number of infliximab-naive participants | Posted | Mean | Standard Deviation | Days | up to 2 years |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remicade | Subjects with active luminal and/or fistulizing Crohn's Disease in the hospital or non-hospital setting. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (13.1) |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialDisclosure@merck.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 2 years |
| 5 years |
| Remission |
|
| Other Reason |
|
| No documentation for end of therapy |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy) | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). | n = number of infliximab-naive participants | Posted | Median | Full Range | Days | up to 2 years |
|
|
|
| Secondary | Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients. | HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). HBI is a score on a scale; <5 (remission), 5-7 (mild disease), 8-16 (moderate disease), >16 (severe disease). | 207 participants had disease activity analyzed using Harvey-Bradshaw Index (HBI) | Posted | Mean | Standard Deviation | Score on a scale | 5 years |
|
|
|
| Primary | Average Dose of Infliximab Per Participant Within the Observation Period | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). | n = number of infliximab-naive participants | Posted | Mean | Standard Deviation | mg/kg | up to 2 years |
|
|
|
| Primary | Median Dose of Infliximab Per Participant Within the Observation Period | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). | n = number of infliximab-naive participants | Posted | Median | Full Range | mg/kg | up to 2 years |
|
|
|
| Primary | Total Dose of Infliximab Per Participant Within the Observation Period | Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval). | 315 of infliximab-naive participants were treated in the active phase of the study. Of these, 191 participants received induction therapy (Weeks 0, 2, and 6); 27 received only induction therapy, 132 received induction therapy and subsequent maintenance therapy, and 32 received induction therapy and subsequent episodic therapy. | Posted | Mean | Standard Deviation | mg/kg | up to 2 years |
|
|
|
| 43 |
| 343 |
| 0 |
| 343 |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (13.1) |
|
| Colonic Stenosis | Gastrointestinal disorders | MedDRA (13.1) |
|
| Crohn's Disease | Gastrointestinal disorders | MedDRA (13.1) |
|
| Ileal Stenosis | Gastrointestinal disorders | MedDRA (13.1) |
|
| Ileus | Gastrointestinal disorders | MedDRA (13.1) |
|
| Intestinal Perforation | Gastrointestinal disorders | MedDRA (13.1) |
|
| Small Intestinal Stenosis | Gastrointestinal disorders | MedDRA (13.1) |
|
| Subileus | Gastrointestinal disorders | MedDRA (13.1) |
|
| Anaphylactic Reaction | Immune system disorders | MedDRA (13.1) |
|
| Cytokine Release Syndrome | Immune system disorders | MedDRA (13.1) |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA (13.1) |
|
| Abscess | Infections and infestations | MedDRA (13.1) |
|
| Anal Abscess | Infections and infestations | MedDRA (13.1) |
|
| Herpes Virus Infection | Infections and infestations | MedDRA (13.1) |
|
| Nasal Abscess | Infections and infestations | MedDRA (13.1) |
|
| Perirectal Abscess | Infections and infestations | MedDRA (13.1) |
|
| Sepsis | Infections and infestations | MedDRA (13.1) |
|
| Aspiration Bone Marrow | Investigations | MedDRA (13.1) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) |
|
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (13.1) |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA (13.1) |
|
| B-cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) |
|
| Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) |
|
| Colon Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) |
|
| Cluster Headache | Nervous system disorders | MedDRA (13.1) |
|
| Headache | Nervous system disorders | MedDRA (13.1) |
|
| Simple Partial Seizures | Nervous system disorders | MedDRA (13.1) |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (13.1) |
|
| Abscess Drainage | Surgical and medical procedures | MedDRA (13.1) |
|
| Appendicectomy | Surgical and medical procedures | MedDRA (13.1) |
|
| Colectomy | Surgical and medical procedures | MedDRA (13.1) |
|
| Enterostomy | Surgical and medical procedures | MedDRA (13.1) |
|
| Enterostomy Closure | Surgical and medical procedures | MedDRA (13.1) |
|
| Hospitalization | Surgical and medical procedures | MedDRA (13.1) |
|
| Intestinal Operation | Surgical and medical procedures | MedDRA (13.1) |
|
Not provided
Not provided
| D007410 | Intestinal Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Interval between infusion 4 & 5, n=227 |
|
| Interval between infusion 5 & 6, n=210 |
|
| Interval between infusion 6 & 7, n=186 |
|
| Interval between infusion 7 & 8, n=162 |
|
| Interval between infusion 8 & 9, n=148 |
|
| Title | Measurements |
|---|---|
|
| Infusion 4, n=20 |
|
| Infusion 5, n=23 |
|
| Infusion 6, n=24 |
|
| Infusion 7, n=17 |
|
| Infusion 8, n=17 |
|
| Infusion 9, n=15 |
|
| Title | Measurements |
|---|---|
|
| Infusion 4, n=253 |
|
| Infusion 5, n=227 |
|
| Infusion 6, n=210 |
|
| Infusion 7, n=186 |
|
| Infusion 8, n=163 |
|
| Infusion 9, n=148 |
|
| Title | Measurements |
|---|---|
|
| Infusion 4, n=253 |
|
| Infusion 5, n=227 |
|
| Infusion 6, n=210 |
|
| Infusion 7, n=186 |
|
| Infusion 8, n=163 |
|
| Infusion 9, n=148 |
|