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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716039
First Posted: October 29, 2012
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Western University, Canada ( University of Western Ontario, Canada )
October 15, 2012
October 29, 2012
March 24, 2017
June 2013
May 2017   (Final data collection date for primary outcome measure)
Pharmacokinetic Analysis (PK) will measure antidrug antibodies (ADAs)and plasma concentrations of adalimumab and methotrexate. [ Time Frame: 20 weeks ]

PK parameters will include:

  • Maximum plasma concentration (Cmax)
  • Time to reach Cmax (Tmax)
  • Area under the concentration time curve (AUC)
  • Elimination rate constant (k) Elimination half-life (t1/2)
Same as current
Complete list of historical versions of study NCT01716039 on ClinicalTrials.gov Archive Site
  • Clinical and Endoscopic Evaluation of the Efficacy of Combination Therapy [ Time Frame: 20 weeks ]
    The primary efficacy outcome will be assessed by comparing the change in the modified Baron score from baseline to the final visit between the treatment groups
  • Identify covariates [ Time Frame: 20 weeks ]
    To identify covariates (gender, weight, BMI, albumin, TNF, CRP, disease severity, concomitant medications) that might influence the clearance and or disposition of adalimumab
  • Relationship between PK and efficacy [ Time Frame: 20 weeks ]
    To evaluate the relationship between PK and efficacy (PD)
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC)
A Study to Evaluate the Pharmacokinetics of Adalimumab in Combination With Methotrexate for the Treatment of Patients With Ulcerative Colitis
Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active ulcerative colitis.
Assess the Pharmacokinetic dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active UC.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: 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

    Other Name: MTX
  • 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

    Other Name: MTX
  • Drug: Adalimumab
    Subjects will receive 18 weekly doses of adalimumab
    Other Name: Humira
  • Active Comparator: 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
    Interventions:
    • Drug: MTX 12.5
    • Drug: Adalimumab
  • Active Comparator: 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
    Interventions:
    • Drug: MTX 25
    • Drug: Adalimumab
  • Placebo Comparator: 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: Drug: Adalimumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
November 2017
May 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01716039
RP1204
No
Not Provided
Not Provided
Western University, Canada ( University of Western Ontario, Canada )
University of Western Ontario, Canada
Abbott
Principal Investigator: Brian Feagan, MD Robarts Research Institute - Western University
Western University, Canada
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP