A Study to Evaluate the Pharmacokinetics of Adalimumab in Combination With Methotrexate for the Treatment of Patients With Ulcerative Colitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Alimentiv Inc.
- Enrollment
- 22
- Primary Endpoint
- Change in the Modified Baron Score From Baseline to the Final Visit (Week 18) Between the Treatment Groups
Study Overview
Brief Summary
Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active ulcerative colitis.
Detailed Description
Assess the Pharmacokinetic dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active UC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Planned surgery.
Arms & Interventions
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
Intervention: MTX 12.5 (Drug)
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
Intervention: Adalimumab (Drug)
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
Intervention: MTX 25 (Drug)
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
Intervention: Adalimumab (Drug)
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
Intervention: Adalimumab (Drug)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Change in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Score From Baseline to the Final Visit (Week 18) Between the Treatment Groups.(Baseline up to Week 18)