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

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

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Drug: Adalimumab

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrd
    • Madrid, Madrd, Spain, 28046
      • Recruiting
      • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adalimumab trough level	Drug levels will be measured during 12 weeks of treatment	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibodies to Adalimumab (ADA)	Antibodies to Adalimumab will be tested for 12 weeks of treatment	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).	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.	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.	12 weeks
Fecal calprotectin	Fecal calprotectin levels will be tested during the study	12 weeks
Blood acute phase reactants	Blood acute phase reactants will be tested during the study	12 weeks
QOL	Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire	12 weeks
Treatment Satisfaction	Treatment Satisfaction Questionnaire for Medication (TSQM)	12 weeks

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz
• Investigators: Study Director: Maria Dolores Martin Arranz, PhD, Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Therapeutic drug monitoring; Inflammatory Bowel Diseases; Adalimumab; AntiTNF
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: IntnsificADA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No