NCT01716039 - Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

July 18, 2016

Study Completion Date

July 18, 2016

Conditions

Ulcerative Colitis

Interventions

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