Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-10-30

Brief Summary

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RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.

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Detailed Description

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IBD patients in need of intensified adalimumab treatment will be randomized to receive 40mg sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will be allocated to the other dosing regime. Adalimumab blood levels and other features such as specific drug antibodies and disease activity parameters will be compared between both groups.

Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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40mg1w

Adalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks

Group Type ACTIVE_COMPARATOR

Adalimumab

Intervention Type DRUG

Monoclonal antibody used in IBD treatment

80mg2w

Adalimumab at an administration of 80 mg every two weeks

Group Type ACTIVE_COMPARATOR

Adalimumab

Intervention Type DRUG

Monoclonal antibody used in IBD treatment

Interventions

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Adalimumab

Monoclonal antibody used in IBD treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients \> 18y
* Intensified adalimumab regime at least 4 weeks prior to enrollment.
* Immunosuppressants are allowed if a stable dose for \> 12w is maintained.
* Corticosteroids are allowed if they were initiated prior to enrollment and a stable dose is maintained.