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

Phase 3
Conditions
Inflammatory Bowel Diseases
Interventions
Registration Number
NCT04404517
Lead Sponsor
Hospital Universitario La Paz
Brief Summary

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

Detailed 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
20
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.
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Exclusion Criteria
  • Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.
  • Pregnant or lactating women.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
80mg2wAdalimumabAdalimumab at an administration of 80 mg every two weeks
40mg1wAdalimumabAdalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks
Primary Outcome Measures
NameTimeMethod
Adalimumab trough level12 weeks

Drug levels will be measured during 12 weeks of treatment

Secondary Outcome Measures
NameTimeMethod
Clinical response for Ulcerative Colitis12 weeks

Simple Clinical Colitis Activity Index (SCCAI) (for UC) refers to disease symptoms during the previous week. It is composed of six domains. After recording, the clinician-based SCCAI is able to categorize two types of patients: patients with inactive disease (SCCAI\<5) and patients with active disease (SCCAI≥5).

Clinical response for Ulcerative colitis12 weeks

Truelove Index (for UC), is composed of 6 variables. Clinical remission was defined as 1 or 2 stools per day without blood, absence of fever or tachycardia, a normal hemoglobin or "returning towards normal," a normal ESR or "returning towards normal," and gaining weight.

Clinical response for Crohn´s Disease12 weeks

Harvey-Bradshaw Index (for CD) considers five parameters. For each parameter a specific score is assigned. A score below 5 is considered as clinical remission. A reduction of 3 points is considered as relevant to define clinical response.

Fecal calprotectin12 weeks

Fecal calprotectin levels will be tested during the study

Blood acute phase reactants12 weeks

Blood acute phase reactants will be tested during the study

Antibodies to Adalimumab (ADA)12 weeks

Antibodies to Adalimumab will be tested for 12 weeks of treatment

Treatment Satisfaction12 weeks

Treatment Satisfaction Questionnaire for Medication (TSQM)

QOL12 weeks

Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire

Trial Locations

Locations (1)

Hospital Universitario La Paz

🇪🇸

Madrid, Madrd, Spain

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