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

Alimentiv

Status and phase: Terminated; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: MTX 12.5; Drug: Adalimumab; Drug: MTX 25

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01716039

RP1204

Details and patient eligibility

About

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

Full description

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

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 3 patient groups, including a placebo group

MTX 12.5

Active Comparator group

Description:

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

Treatment:

Drug: Adalimumab

Drug: MTX 12.5

MTX 25 mg

Active Comparator group

Description:

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

Treatment:

Drug: MTX 25

Drug: Adalimumab

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Adalimumab