Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

AbbVie

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Biological: Placebo; Biological: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02065557

2013-003032-77 (EudraCT Number)

M11-290

Details and patient eligibility

About

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).

Enrollment: 101 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 6 patient groups, including a placebo group

Adalimumab Induction Standard Dose

Experimental group

Description:

Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.

Treatment:

Biological: Placebo

Biological: Adalimumab

Adalimumab Induction High Dose

Experimental group

Description:

Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.

Treatment:

Biological: Adalimumab

Adalimumab Induction High Dose - Open Label

Experimental group

Description:

(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.

Treatment:

Biological: Adalimumab

Maintenance Placebo

Placebo Comparator group

Description:

(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.

Treatment:

Biological: Placebo

Biological: Adalimumab

Adalimumab Maintenance Standard Dose

Experimental group

Description:

Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \[maximum dose of 40 mg\] every other week). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after second flare.

Treatment:

Biological: Adalimumab

Adalimumab Maintenance High Dose

Experimental group

Description:

Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \[maximum dose of 40 mg\] every week). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after second flare.

Treatment:

Biological: Adalimumab