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

Madrid Health Service

Status and phase: Unknown; Phase 3

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04404517

IntnsificADA

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.
• Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

40mg1w

Active Comparator group

Description:

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

Treatment:

Drug: Adalimumab

80mg2w

Active Comparator group

Description:

Adalimumab at an administration of 80 mg every two weeks

Treatment:

Drug: Adalimumab