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

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

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.

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

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Drug: Adalimumab


Participation Criteria
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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. Exclusion Criteria: Patients unable to understand study protocol, study procedures or not capacitated to give informed consent. Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 40mg1w<br>Adalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks | Drug: Adalimumab<br>* Monoclonal antibody used in IBD treatment<br>|
| Active Comparator: 80mg2w<br>Adalimumab at an administration of 80 mg every two weeks | Drug: Adalimumab<br>* Monoclonal antibody used in IBD treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adalimumab trough level | Drug levels will be measured during 12 weeks of treatment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibodies to Adalimumab (ADA) | Antibodies to Adalimumab will be tested for 12 weeks of treatment | 12 weeks | 
| Clinical response for Ulcerative Colitis | 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). | 12 weeks | 
| Clinical response for Ulcerative colitis | 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. | 12 weeks | 
| Clinical response for Crohn´s Disease | 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. | 12 weeks | 
| Fecal calprotectin | Fecal calprotectin levels will be tested during the study | 12 weeks | 
| Blood acute phase reactants | Blood acute phase reactants will be tested during the study | 12 weeks | 
| QOL | Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire | 12 weeks | 
| Treatment Satisfaction | Treatment Satisfaction Questionnaire for Medication (TSQM) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AntiTNF, Inflammatory Bowel Diseases, Adalimumab, Therapeutic drug monitoring