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

NCT01716039 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-06-23

Study results available
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Summary

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

Conditions

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

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Alimentiv Inc.

    lead OTHER

Principal Investigators

  • Brian Feagan, MD · Robarts Research Institute - Western University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-07-18
Completion
2016-07-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01716039 on ClinicalTrials.gov