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

Sponsor
Alimentiv Inc.
Study ID
NCT01716039
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MTX 12.5 — DRUG
    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
  • MTX 25 — DRUG
    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
  • Adalimumab — DRUG
    Subjects will receive 18 weekly doses of adalimumab

Study Details

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

Key Dates

Start date
Jun 30, 2013
Status verified
Jun 2021
Primary completion
Jul 18, 2016
Completion
Jul 18, 2016

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: MTX 12.5
    Receive once weekly oral dosing with MTX 12.5 mg (n=40) two weeks prior to the initiation of adalimumab 18 weekly doses of MTX and/or placebo in addition to doses of adalimumab
  • Active Comparator: MTX 25 mg
    Once weekly oral dosing with MTX 25 mg (n=40) two weeks prior to the initiation of adalimumab 18 weekly doses of MTX in addition to doses of adalimumab
  • Placebo Comparator: Placebo
    Once weekly oral dosing with placebo (n=20) two weeks prior to the initiation of adalimumab. Subjects will receive 18 weekly doses of placebo in addition to doses of adalimumab

Primary Outcome Measure

Change in the Modified Baron Score From Baseline to the Final Visit (Week 18) Between the Treatment Groups [ Time Frame: Baseline up to Week 18 ]

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