Who is sponsoring NCT01716039?

NCT01716039 is sponsored by Alimentiv Inc..

What condition does NCT01716039 study?

NCT01716039 studies Ulcerative Colitis.

What drugs are being tested in NCT01716039?

Interventions: MTX 12.5, MTX 25, Adalimumab.

What is the status of NCT01716039?

NCT01716039 is currently TERMINATED.

Last reviewed 2021-06-01 · How we verify

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

NCT01716039 Phase 2 TERMINATED Results posted

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

Details

Lead sponsor	Alimentiv Inc.
Phase	Phase 2
Status	TERMINATED
Enrolment	22
Start date	2013-06
Completion	2016-07-18

Conditions

Ulcerative Colitis

Interventions

MTX 12.5
MTX 25
Adalimumab

Primary outcomes

Change in the Modified Baron Score From Baseline to the Final Visit (Week 18) Between the Treatment Groups — Baseline up to Week 18
The modified Baron score is scored on a 0-4 scale that evaluates friability, vascular pattern, bleeding and ulceration on a 5-point grading scale with a higher score indicating more severe disease activity. The mean change and 95% CI are based on least square means from the analysis of covariance