Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04624230 | Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | PHASE3 | ACTIVE NOT_RECRUITING | 118 | — | — | Aug 12, 2021 | Jul 4, 2029 | Jun 2, 2026 | 68 | United States, Australia +14 |
| NCT01458951 | A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis | PHASE3 | COMPLETED | 547 | — | — | Jun 1, 2012 | Jun 1, 2015 | Jun 1, 2016 | 182 | United States, Australia +27 |
| NCT01465763 | A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis | PHASE3 | COMPLETED | 614 | — | — | Apr 1, 2012 | May 1, 2015 | Jun 7, 2016 | 178 | United States, Australia +26 |
| NCT00787202 | A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis. | PHASE2 | COMPLETED | 195 | — | — | Dec 1, 2008 | Sep 1, 2010 | Apr 16, 2013 | 59 | Belgium, Brazil +15 |
Remission is defined by central endoscopy read Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. The primary outcome Mayo score is the summation of 4 subscores as listed below : * patient reported stool frequency (scored 0 to 3) * patient reported rectal bleeding (scored 0 to 3) * central read findings on endoscopy (scored 0 to 3) * physician's global assessment (scored 0 to 3) The Mayo score has a scale from 0 to 12 points, with the lower score indicating lower ulcerative colitis (UC) disease activity.
Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.
Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
| Arm | Type | Description |
|---|---|---|
| tofacitinib | EXPERIMENTAL | Open label tofacitinib 5 mg BID weight based adult equivalent with the option for individual dose increase to 10 mg BID weight based adult equivalent for a limited time if dose escalation criteria are met, prior to returning to 5 mg BID. |
| tofacitinib 10 mg BID | EXPERIMENTAL | - |
| Placebo BID | PLACEBO_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 15 mg BID | EXPERIMENTAL | - |
| 10 mg BID | EXPERIMENTAL | - |
| 3 mg BID | EXPERIMENTAL | - |
| 0.5 mg BID | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| tofacitinib | DRUG | Open label tofacitinib 5 mg BID weight based adult equivalent with the option for individual dose increase to 10 mg BID weight based adult equivalent for a limited time if dose escalation criteria are met, prior to returning to 5 mg BID. |
| Placebo | DRUG | Placebo oral BID |
| CP- 690 550 | DRUG | Administration via oral route twice daily for the duration of treatment |
Inclusion Criteria: * Evidence of a personally signed and dated informed consent document and assent document. * Males and females 2 to less than18 years old and weighing at least 10 kg. * Having a pathology report that confirms colonic inflammation consistent with UC with a clinical diagnosis of U...