Phase 3
Completed N=101
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Ulcerative Colitis
Source: ClinicalTrials.gov NCT02065557 ↗
Enrolled (actual)
101
Serious AEs
15.2%
Results posted
Oct 2020
Primary outcomePrimary: Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period — 43.3; 59.6; 53.2; 68.8 percentage of participants — p=< 0.001
Summary
The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period |
43.3; 59.6; 53.2; 68.8; 40.6; 58.8 | < 0.001 sig |
| PRIMARY Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period |
33.3; 29.0; 45.2; 37.1; 33.3; 27.3 | < 0.001 sig |
| SECONDARY Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period |
33.3; 61.3; 67.7; 64.5; 33.3; 57.6 | < 0.001 sig |
| SECONDARY Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period |
33.3; 38.7; 51.6; 45.2; 33.3; 36.4 | < 0.001 sig |
| SECONDARY Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period |
37.5; 42.9; 45.5; 44.2; 37.5; 42.9 | < 0.001 sig |
| SECONDARY Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period |
40.0; 30.8; 31.3; 31.0; 40.0; 26.7 | 0.382 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy.
- Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.
Exclusion Criteria
- Subject with Crohn's disease (CD) or indeterminate colitis (IC).
- Current diagnosis of fulminant colitis and/or toxic megacolon.
- Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
- Chronic recurring infections or active tuberculosis (TB).
Data sourced from ClinicalTrials.gov (NCT02065557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.