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

Inflammatory Bowel Diseases Clinical Trial

— IntnsificADA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04404517
• Other study ID #: IntnsificADA
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: July 2021
• Source: Hospital Universitario La Paz
• Contact: Eduardo Martin Arranz, PhD
• Phone: +34912071350
• Email: emarranz[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Adalimumab
Monoclonal antibody used in IBD treatment

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid	Madrd

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adalimumab trough level	Drug levels will be measured during 12 weeks of treatment	12 weeks
Secondary	Antibodies to Adalimumab (ADA)	Antibodies to Adalimumab will be tested for 12 weeks of treatment	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Fecal calprotectin	Fecal calprotectin levels will be tested during the study	12 weeks
Secondary	Blood acute phase reactants	Blood acute phase reactants will be tested during the study	12 weeks
Secondary	QOL	Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire	12 weeks
Secondary	Treatment Satisfaction	Treatment Satisfaction Questionnaire for Medication (TSQM)	12 weeks