Inflammatory Bowel Diseases
Conditions
Keywords
AntiTNF, Inflammatory Bowel Diseases, Adalimumab, Therapeutic drug monitoring
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.
Interventions
DRUGAdalimumab
Monoclonal antibody used in IBD treatment
Sponsors
Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adalimumab trough level | 12 weeks | Drug levels will be measured during 12 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Antibodies to Adalimumab (ADA) | 12 weeks | Antibodies to Adalimumab will be tested for 12 weeks of treatment |
| Blood acute phase reactants | 12 weeks | Blood acute phase reactants will be tested during the study |
| QOL | 12 weeks | Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire |
| Treatment Satisfaction | 12 weeks | Treatment Satisfaction Questionnaire for Medication (TSQM) |
| Fecal calprotectin | 12 weeks | Fecal calprotectin levels will be tested during the study |
Countries
Spain
Contacts
Primary ContactEduardo Martin Arranz, PhD
Outcome results
None listed