Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks (IntnsificADA)
Primary Purpose
Inflammatory Bowel Diseases
Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring AntiTNF, Inflammatory Bowel Diseases, Adalimumab, Therapeutic drug monitoring
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario La PazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
40mg1w
80mg2w
Arm Description
Adalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks
Adalimumab at an administration of 80 mg every two weeks
Outcomes
Primary Outcome Measures
Adalimumab trough level
Drug levels will be measured during 12 weeks of treatment
Secondary Outcome Measures
Antibodies to Adalimumab (ADA)
Antibodies to Adalimumab will be tested for 12 weeks of treatment
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).
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.
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.
Fecal calprotectin
Fecal calprotectin levels will be tested during the study
Blood acute phase reactants
Blood acute phase reactants will be tested during the study
QOL
Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire
Treatment Satisfaction
Treatment Satisfaction Questionnaire for Medication (TSQM)
Full Information
NCT ID
NCT04404517
First Posted
September 16, 2019
Last Updated
July 22, 2021
Sponsor
Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT04404517
Brief Title
Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
Acronym
IntnsificADA
Official Title
Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
AntiTNF, Inflammatory Bowel Diseases, Adalimumab, Therapeutic drug monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
40mg1w
Arm Type
Active Comparator
Arm Description
Adalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks
Arm Title
80mg2w
Arm Type
Active Comparator
Arm Description
Adalimumab at an administration of 80 mg every two weeks
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
Monoclonal antibody used in IBD treatment
Primary Outcome Measure Information:
Title
Adalimumab trough level
Description
Drug levels will be measured during 12 weeks of treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Antibodies to Adalimumab (ADA)
Description
Antibodies to Adalimumab will be tested for 12 weeks of treatment
Time Frame
12 weeks
Title
Clinical response for Ulcerative Colitis
Description
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).
Time Frame
12 weeks
Title
Clinical response for Ulcerative colitis
Description
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.
Time Frame
12 weeks
Title
Clinical response for Crohn´s Disease
Description
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.
Time Frame
12 weeks
Title
Fecal calprotectin
Description
Fecal calprotectin levels will be tested during the study
Time Frame
12 weeks
Title
Blood acute phase reactants
Description
Blood acute phase reactants will be tested during the study
Time Frame
12 weeks
Title
QOL
Description
Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire
Time Frame
12 weeks
Title
Treatment Satisfaction
Description
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Martin Arranz, PhD
Phone
+34912071350
Email
emarranz@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Dolores Martin Arranz, PhD
Organizational Affiliation
Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
State/Province
Madrd
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Martin Arranz, PhD
Phone
+34912071350
Email
emarranz@salud.madrid.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
We'll reach out to this number within 24 hrs