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| ID | Type | Description | Link |
|---|---|---|---|
| C0168T72 | Other Identifier | Centocor |
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The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
Ulcerative Colitis (UC) is a disorder involving the lining of the colon. A substance called "tumor necrosis factor" (TNF) naturally occurs in the body. TNF is thought to play an important role in the development of ulcerative colitis by causing some of the damage that is seen in the colon. "Antibodies" are normally made in the body and help fight off infection. Infliximab is an antibody that is made in a scientific laboratory, using parts of both mouse and human antibodies. It has been designed to attach to TNF, making it difficult for TNF to do any damage. This study will be done at centers in North America and Europe. Each child will first have a clinic visit (screening visit) to have some tests done to make sure the child is the type of patient who should be in this study. At the 2nd visit (week 0), the child will have the first treatment with infliximab. All children in the study will receive 5 mg/kg infliximab 3 times (at weeks 0, 2 and 6) over the first 6 weeks of the study. If the child's symptoms do not improve by the 8th week, the child will receive no further infusions, but will return for safety evaluations. If the child's symptoms do improve, the child will be randomly assigned (like the flip of a coin) to either 5 mg/kg infliximab every 8 weeks through week 46 or 5 mg/kg infliximab every 12 weeks through week 42. If the child gets worse after being randomly assigned, the amount of infliximab may be increased or the infliximab may be given more frequently. A final infusion will be given at either week 42 or week 46. There will be a safety evaluation at week 54 and a visit at week 62 to get a blood sample. Patients will receive 5 mg/kg of infliximab at weeks 0, 2 and 6 and then 5mg/kg infliximab either every 8 weeks or 12 weeks until weeks 42 or 46. Infliximab is given as an intravenous infusion over 2 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 002 | Experimental | infliximab infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42 |
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| 001 | Experimental | infliximab infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infliximab | Biological | infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Clinical Response at Week 8 | Range is 0 to 12 points, where 0 is the least disease activity, and 12 is the most disease activity. Clinical response at Week 8 is defined as a decrease from baseline in the Mayo score(based on symptoms of ulcerative colitis) by >=30% and >= 3 points, with a decrease in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. Treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited medication changes) were applied to determine the final clinical response status for each patient. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54 | Range is 0 to 85 points, where 0 is the least disease activity, and 85 is the most disease activity. Remission is a score <10. In addition to the PUCAI remission status, treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, had protocol-prohibited medication changes, or stepped up) were applied to determine the final PUCAI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29925913 | Derived | Singh S, Proudfoot JA, Dulai PS, Jairath V, Fumery M, Xu R, Feagan BG, Sandborn WJ. No Benefit of Concomitant 5-Aminosalicylates in Patients With Ulcerative Colitis Escalated to Biologic Therapy: Pooled Analysis of Individual Participant Data From Clinical Trials. Am J Gastroenterol. 2018 Aug;113(8):1197-1205. doi: 10.1038/s41395-018-0144-2. Epub 2018 Jun 21. |
| Label | URL |
|---|---|
| A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative Colitis | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Not Randomized Group | Participants who were not randomized at Week 8 |
| FG001 | 5 mg/kg Infliximab Every 8 Wks | Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| infliximab | Biological | infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46 |
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| infliximab | Biological | infliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42 |
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| infliximab | Biological | infusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42 |
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| Week 54 |
| Phoenix |
| Arizona |
| United States |
| Los Angeles | California | United States |
| Denver | Colorado | United States |
| Hartford | Connecticut | United States |
| Orlando | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| Boston | Massachusetts | United States |
| Rochester | Minnesota | United States |
| New Hyde Park | New York | United States |
| Durham | North Carolina | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Dayton | Ohio | United States |
| Providence | Rhode Island | United States |
| Milwaukee | Wisconsin | United States |
| Antwerp | Belgium |
| Leuven | Belgium |
| Vancouver | British Columbia | Canada |
| Hamilton | Ontario | Canada |
| Toronto | Ontario | Canada |
| Edmonton | Canada |
| Halifax | Canada |
| Hvidovre | Denmark |
| Rotterdam | Netherlands |
| FG002 | 5 mg/kg Infliximab Every 12 Wks | Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Not Randomized Group | Participants who were not randomized at Week 8 |
| BG001 | 5 mg/kg Infliximab Every 8 Wks | Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks |
| BG002 | 5 mg/kg Infliximab Every 12 Wks | Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | The Number of Participants With Clinical Response at Week 8 | Range is 0 to 12 points, where 0 is the least disease activity, and 12 is the most disease activity. Clinical response at Week 8 is defined as a decrease from baseline in the Mayo score(based on symptoms of ulcerative colitis) by >=30% and >= 3 points, with a decrease in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. Treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited medication changes) were applied to determine the final clinical response status for each patient. | The primary efficacy endpoint analysis was based on all treated participants. | Posted | Number | Participants | Week 8 |
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| Secondary | The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54 | Range is 0 to 85 points, where 0 is the least disease activity, and 85 is the most disease activity. Remission is a score <10. In addition to the PUCAI remission status, treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, had protocol-prohibited medication changes, or stepped up) were applied to determine the final PUCAI. | PUCAI remission at Week 54 analysis was based on all participants randomized at Week 8 who were evaluable for PUCAI. Fifteen participants discontinued Infliximab treatment. | Posted | Number | Participants | Week 54 |
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Data for subjects who stepped up are included according to the regimen received before step-up.
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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 | Not Randomized Group | Participants who were not randomized at Week 8 | 5 | 15 | 10 | 15 | ||
| EG001 | 5 mg/kg Infliximab Every 8 Wks | Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks | 4 | 22 | 19 | 22 | ||
| EG002 | 5 mg/kg Infliximab Every 12 Wks | Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks | 5 | 23 | 22 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Colitis Ulcerative | Gastrointestinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | WhoArtCENT 200606 | Non-systematic Assessment |
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| Infection | Infections and infestations | WhoArtCENT 200606 | Non-systematic Assessment |
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| Infection Viral | Infections and infestations | WhoArtCENT 200606 | Non-systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Pneumonia Lobar | Respiratory, thoracic and mediastinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Thrombocythemia | Blood and lymphatic system disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Blood in Stool | Gastrointestinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Colitis Ulcerative | Gastrointestinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Stomatitis Ulcerative | Gastrointestinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Chest Pain | General disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Chills | General disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Pain | General disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Hepatic Enzymes Increased | Hepatobiliary disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Fever | Infections and infestations | WhoArtCENT 200606 | Non-systematic Assessment |
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| Infection Bacterial | Infections and infestations | WhoArtCENT 200606 | Non-systematic Assessment |
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| Inflammation | Infections and infestations | WhoArtCENT 200606 | Non-systematic Assessment |
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| Influenza | Infections and infestations | WhoArtCENT 200606 | Non-systematic Assessment |
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| Influenza-Like Symptoms | Infections and infestations | WhoArtCENT 200606 | Non-systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Headache | Nervous system disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Thinking Abnormal | Psychiatric disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Urinary Tract Infection | Renal and urinary disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Coughing | Respiratory, thoracic and mediastinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Throat Tightness | Respiratory, thoracic and mediastinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Hemorrhoids | Vascular disorders | WhoArtCENT 200606 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Clinical Research | Johnson & Johnson Pharmaceutical Research and Development | 610-240-8092 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Male |
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