RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Monoclonal antibody used in IBD treatment
Hospital Universitario La Paz
Madrid, Madrd, Spain
RECRUITINGAdalimumab trough level
Drug levels will be measured during 12 weeks of treatment
Time frame: 12 weeks
Antibodies to Adalimumab (ADA)
Antibodies to Adalimumab will be tested for 12 weeks of treatment
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Fecal calprotectin
Fecal calprotectin levels will be tested during the study
Time frame: 12 weeks
Blood acute phase reactants
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Blood acute phase reactants will be tested during the study
Time frame: 12 weeks
QOL
Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire
Time frame: 12 weeks
Treatment Satisfaction
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 12 weeks