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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-07-18

Brief Summary

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

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Detailed Description

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

Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

MTX 12.5

Intervention Type 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

Adalimumab

Intervention Type DRUG

Subjects will receive 18 weekly doses of adalimumab

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

Group Type ACTIVE_COMPARATOR

MTX 25

Intervention Type 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

Intervention Type DRUG

Subjects will receive 18 weekly doses of adalimumab

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

Group Type PLACEBO_COMPARATOR

Adalimumab

Intervention Type DRUG

Subjects will receive 18 weekly doses of adalimumab

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Adalimumab

Subjects will receive 18 weekly doses of adalimumab

Intervention Type DRUG

Other Intervention Names

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MTX MTX Humira

Eligibility Criteria

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Inclusion Criteria

* Male or non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal \[defined as a minimum of one year since the last menstrual period\]).
* Diagnosis of UC confirmed by established criteria, regardless of disease duration.
* Moderate to severely active UC, defined by a modified Mayo Score ≥6, with confirmed endoscopic activity by central reader (Mayo endoscopic subscore ≥2).
* Require initiation with adalimumab for induction of remission.
* Ability of subject to swallow study drug capsules.
* Ability of subject to participate fully in all aspects of this clinical trial.
* Written informed consent must be obtained and documented.

Exclusion Criteria

* Prior treatment with a TNF antagonist or biological therapy.
* Prior treatment with MTX.
* Disease limited to the rectum (proctitis).
* Documented presence of antibodies against adalimumab.
* Contraindication for anti-TNF or MTX therapy.
* Contraindication for endoscopy.
* Ostomy.
* Planned surgery.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No