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insufficient enrollment
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Prospective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight-based | Active Comparator | Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily. |
|
| Fixed dose | Active Comparator | Corticosteroid dose fixed at equivalent to 40mg prednisone daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid | Drug | Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Remission at End of 2 Weeks | Number of participants with Harvey Bradshaw Index < 5 at end of 2 weeks. The minimum score obtainable is 0, suggesting absence of disease or remission, while the maximum score obtainable goes beyond 18 points, depending on the number of stools the patient identifies per day (because 1 point is given for each stool in a day, there is no specific maximum score. A higher score represents more severe disease. <5 is determined to be remission. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Response at End of 2 Weeks | Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks | 2 weeks |
| Number of Participants With Response or Remission at End of 1 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loren Laine, MD | Yale University, Section of Digestive Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Weight-based | Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily. Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy. |
| FG001 | Fixed Dose | Corticosteroid dose fixed at equivalent to 40mg prednisone daily. Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Weight-based | Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily. Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy. |
| BG001 | Fixed Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Participants in Remission at End of 2 Weeks | Number of participants with Harvey Bradshaw Index < 5 at end of 2 weeks. The minimum score obtainable is 0, suggesting absence of disease or remission, while the maximum score obtainable goes beyond 18 points, depending on the number of stools the patient identifies per day (because 1 point is given for each stool in a day, there is no specific maximum score. A higher score represents more severe disease. <5 is determined to be remission. | 1 patient in fixed dose group did not return for this assessment. | Posted | Count of Participants | Participants | 2 weeks |
|
Up to 12 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 | Weight-based | Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily. Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Crohn's disease | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mood swings | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Loren Laine | Yale | 203-785-7312 | loren.laine@yale.edu |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D011241 | Prednisone |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
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|
Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 1 week
| 1 week |
| Number of Participants With Response or Remission at End of 4 Weeks | Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 4 weeks | 4 weeks |
| Number of Participants With Response or Remission at End of 12 Weeks | Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 12 weeks | 12 weeks |
| Number of Participants With Corticosteroid-associated Side Effects | Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias. | 12 weeks |
Corticosteroid dose fixed at equivalent to 40mg prednisone daily. Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Fixed Dose | Corticosteroid dose fixed at equivalent to 40mg prednisone daily. Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy. |
|
|
| Secondary | Number of Participants With Response at End of 2 Weeks | Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks | 1 patient in fixed-dose group did not return for this assessment. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Number of Participants With Response or Remission at End of 1 Week | Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 1 week | 1 patient in weight-based group and 2 patients in fixed-dose group did not return for this assessment. | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Secondary | Number of Participants With Response or Remission at End of 4 Weeks | Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 4 weeks | 2 patients in weight-based group and 1 patient in fixed-dose group did not return for this assessment. | Posted | Count of Participants | Participants | 4 weeks |
|
|
|
| Secondary | Number of Participants With Response or Remission at End of 12 Weeks | Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 12 weeks | 1 patient in fixed-dose group did not return for this assessment. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Number of Participants With Corticosteroid-associated Side Effects | Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias. | 1 patient in fixed dose did not return and did not have any assessment for this outcome after randomization. | Posted | Count of Participants | Participants | 12 weeks |
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|
| 0 |
| 7 |
| 1 |
| 7 |
| 5 |
| 7 |
| EG001 | Fixed Dose | Corticosteroid dose fixed at equivalent to 40mg prednisone daily. Corticosteroid: Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy. | 0 | 8 | 4 | 8 | 7 | 8 |
| Sleep disturbance | Psychiatric disorders | Systematic Assessment |
|
| Edema | Endocrine disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |