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

Sponsor

Hospital Universitario La Paz (Other)

Overall Status

Recruiting

CT.gov ID

NCT04404517

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Drug: Adalimumab	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Oct 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 40mg1w 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 Monoclonal antibody used in IBD treatment
Active Comparator: 80mg2w Adalimumab at an administration of 80 mg every two weeks	Drug: Adalimumab Monoclonal antibody used in IBD treatment

Arm

Intervention/Treatment

Active Comparator: 40mg1w

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

Monoclonal antibody used in IBD treatment

Active Comparator: 80mg2w

Adalimumab at an administration of 80 mg every two weeks

Drug: Adalimumab

Monoclonal antibody used in IBD treatment

Outcome Measures

Primary Outcome Measures

Adalimumab trough level [12 weeks]
Drug levels will be measured during 12 weeks of treatment

Secondary Outcome Measures

Antibodies to Adalimumab (ADA) [12 weeks]
Antibodies to Adalimumab will be tested for 12 weeks of treatment
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
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.