Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
- 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
- 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.
- Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.
- Pregnant or lactating women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 80mg2w Adalimumab Adalimumab at an administration of 80 mg every two weeks 40mg1w Adalimumab Adalimumab 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
Name Time Method Adalimumab trough level 12 weeks Drug levels will be measured during 12 weeks of treatment
- Secondary Outcome Measures
Name Time Method Clinical response for Ulcerative Colitis 12 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 colitis 12 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 Disease 12 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 calprotectin 12 weeks Fecal calprotectin levels will be tested during the study
Blood acute phase reactants 12 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 Satisfaction 12 weeks Treatment Satisfaction Questionnaire for Medication (TSQM)
QOL 12 weeks Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire
Trial Locations
- Locations (1)
Hospital Universitario La Paz
🇪🇸Madrid, Madrd, Spain