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Keep this study
Lead
Alimentiv Inc.
With
Abbott
Assess the Pharmacokinetic dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active UC.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
