Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

Primary outcomes

1. Number of Participants With Adverse Events (AEs)

   Time frame: From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks).

   An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

2. Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS)

   Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

   The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores:

   • Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
   • Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
   • Physician's Global Assessment (PGA), scored from 0 (normal) to 3 (severe disease).

   The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease.

   Clinical remission was defined as a PMS ≤ 2 and no individual subscore > 1.

3. Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline)

   Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

   The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores:

   • Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).
   • Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).
   • Physician's Global Assessment (PGA), scored from 0 (normal) to 3 (severe disease).

   The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease.

   Clinical response was defined as a decrease in PMS ≥ 2 points and ≥ 30% from Study M11-290 Baseline.

4. Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission

   Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

   The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level.

   The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease.

   Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe).

   Clinical remission was defined as a PUCAI score < 10.

5. Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline)

   Time frame: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

   The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level.

   The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease.

   Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe).

   PUCAI response was defined as a decrease in PUCAI score ≥ 20 points from Study M11-290 Baseline.