NCT01716039

Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC)

A Study to Evaluate the Pharmacokinetics of Adalimumab in Combination With Methotrexate for the Treatment of Patients With Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Alimentiv Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active ulcerative colitis.

Detailed description

Assess the Pharmacokinetic dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active UC.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	MTX 12.5	once weekly oral dosing with MTX 12.5 mg (n=40) two weeks prior to the initiation of adalimumab. Randomization will be stratified by disease activity (modified Mayo Score ≤9 or \>9). Subjects will receive 18 weekly doses of MTX in addition to doses of adalimumab
DRUG	MTX 25	once weekly oral dosing with MTX 25 mg (n=40) two weeks prior to the initiation of adalimumab. Randomization will be stratified by disease activity (modified Mayo Score ≤9 or \>9). Subjects will receive 18 weekly doses of MTX in addition to doses of adalimumab
DRUG	Adalimumab	Subjects will receive 18 weekly doses of adalimumab

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-07-18
• Completion: 2016-07-18
• First posted: 2012-10-29
• Last updated: 2021-06-23
• Results posted: 2021-06-23