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TDM Guided Early Optimization of ADAL in Crohn's Disease

Primary Purpose

Crohn Disease, Drug Monitoring, Inflammatory Bowel Diseases

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Adalimumab

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring IBD, Crohn, adalimumab, ADAL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 or older.
Crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation).
Active disease based on Harvey Bradshaw Index (HBI >5) and elevated C-reactive protein (CRP) (>normal reference range for local laboratory) OR fecal calprotectin (FCP) (>250 µg/g)
Due to commence treatment with ADAL.

Exclusion Criteria:

Severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease.
History of active HIV, hepatitis B or C infection,
Patients with ileostomy/colostomy, ileal-pouch anal anastomosis or severe perianal fistulising disease.
Pregnancy
Prior exposure to ADAL

Sites / Locations

University of Calgary Medical Center (UCMC)
The University of British Columbia
London Health Sciences Centre (LHSC) University Hospital
The Ottawa Hospital, IBD Centre of Excellence
McGill University Hospital Center (MUHC)Recruiting
Centre Hospitalier Universitaire de Sherbrooke (CHUS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Standard clinical care

Active optimization

Arm Description

Adalimumab induction as per standard clinical care: Week 0: 160 mg SC Week 2: 80 mg SC Followed by 40 mg SC every 2 weeks' maintenance therapy

Same as Standard clinical care Arm, except: If ADAL trough ≤15 μg/ml, dose escalation with 80 mg SC at week 6 followed by 40 mg SC every week If ADAL trough >15 μg/ml, no dose escalation and continued standard of care dosing

Outcomes

Primary Outcome Measures

Proportion of subjects who achieved remission

Clinical remission will be scored by a Harvey-Bradshaw Index < 5 AND Biochemical remission will be scored by C-reactive protein < 5 mg/l OR Fecal calprotectin <250 μg/g (combination endpoint)

Secondary Outcome Measures

Proportion of subjects who achieved clinical response

Clinical response will be evaluated by a decreased in Harvey-Bradshaw Index score AND a decreased level of C-reactive protein OR Fecal calprotectin

Therapeutic drug monitoring

Adalimumab drug concentration at week 8 and 12 AND proportion of subjects with antibody to Adalimumab at Week 8 and 12 on the rate i. Clinical response/remission (HBI<5) ii. Biochemical response/remission (CRP within normal reference range) iii. Endoscopic response (SES-CD reduction of ≥50% from baseline) / remission (SES-CD ≤3)

Proportion of steroid free subjects

Steroid free defined as patients being steroid free at Week 12

Subjects well-being

Subjects well-being will be scored using the validated questionnaire Short inflammatory bowel disease questionnaire (SIBDQ)

Rates of complications

Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use.

Full Information

NCT ID

NCT03261102

First Posted

August 22, 2017

Last Updated

March 31, 2023

Sponsor

waqqas.afif

Collaborators

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03261102

Brief Title

TDM Guided Early Optimization of ADAL in Crohn's Disease

Official Title

Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 17, 2017 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

waqqas.afif

Collaborators

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.

Detailed Description

This is an investigator initiated randomized open label study. This study is designed to compare whether increasing the dose of adalimumab based on the level the drug in the blood to a target level early in the treatment course would lead to better outcomes for patients as compared to the standard doses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease, Drug Monitoring, Inflammatory Bowel Diseases

Keywords

IBD, Crohn, adalimumab, ADAL

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

Some of the participants, care providers and investigators will eventually, in the course of the study, have knowledge of the arm they were assigned.

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard clinical care

Arm Type

Active Comparator

Arm Description

Adalimumab induction as per standard clinical care: Week 0: 160 mg SC Week 2: 80 mg SC Followed by 40 mg SC every 2 weeks' maintenance therapy

Arm Title

Active optimization

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Adalimumab

Other Intervention Name(s)

Humira

Primary Outcome Measure Information:

Title

Proportion of subjects who achieved remission

Description

Clinical remission will be scored by a Harvey-Bradshaw Index < 5 AND Biochemical remission will be scored by C-reactive protein < 5 mg/l OR Fecal calprotectin <250 μg/g (combination endpoint)

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Proportion of subjects who achieved clinical response

Description

Clinical response will be evaluated by a decreased in Harvey-Bradshaw Index score AND a decreased level of C-reactive protein OR Fecal calprotectin

Time Frame

From Week 0 to Week 12

Title

Therapeutic drug monitoring

Description

Time Frame

At Week 8, 12

Title

Proportion of steroid free subjects

Description

Steroid free defined as patients being steroid free at Week 12

Time Frame

At Week 12

Title

Subjects well-being

Description

Subjects well-being will be scored using the validated questionnaire Short inflammatory bowel disease questionnaire (SIBDQ)

Time Frame

From Week 0 to Week 12

Title

Rates of complications

Description

Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 or older. Crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation). Active disease based on Harvey Bradshaw Index (HBI >5) and elevated C-reactive protein (CRP) (>normal reference range for local laboratory) OR fecal calprotectin (FCP) (>250 µg/g) Due to commence treatment with ADAL. Exclusion Criteria: Severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease. History of active HIV, hepatitis B or C infection, Patients with ileostomy/colostomy, ileal-pouch anal anastomosis or severe perianal fistulising disease. Pregnancy Prior exposure to ADAL

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carolyne Lemieux, BN, RN

Phone

(514) 934-1934

Ext

45699

carolyne.lemieux@muhc.mcgill.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Meaghan Smith, RN

Phone

(514) 934-1934

Ext

45699

meghan.smith@muhc.mcgill.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Waqqas Afif, MD, FRCPC

Organizational Affiliation

McGill University Health Centre/Research Institute of the McGill University Health Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Calgary Medical Center (UCMC)

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Individual Site Status

Completed

Facility Name

The University of British Columbia

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

Individual Site Status

Completed

Facility Name

London Health Sciences Centre (LHSC) University Hospital

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Individual Site Status

Completed

Facility Name

The Ottawa Hospital, IBD Centre of Excellence

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melissa Tessier

Phone

(613) 737-8899

Ext

73035

metessier@ohri.ca

First Name & Middle Initial & Last Name & Degree

Sanjay Murthy, MD

Facility Name

McGill University Hospital Center (MUHC)

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carolyne Lemieux, BN, RN

Phone

(514) 934-1934

Ext

45699

carolyne.lemieux@muhc.mcgill.ca

First Name & Middle Initial & Last Name & Degree

Meaghan Smith, RN

Phone

(514) 934-1934

Ext

45699

meaghan.smith@muhc.mcgill.ca

First Name & Middle Initial & Last Name & Degree

Waqqas Afif, MD, FRCPC

First Name & Middle Initial & Last Name & Degree

Talat Bessissow, MDCM, FRCPC

First Name & Middle Initial & Last Name & Degree

Alain Bitton, MDCM, FRCPC

First Name & Middle Initial & Last Name & Degree

Che-yung Jeff Chao, MBChB, FRACP

First Name & Middle Initial & Last Name & Degree

Sophie Restellini-Kherad

Facility Name

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1G 2E8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chantal Guillet

Phone

(819) 346-1110

Ext

12812

cguillet.chus@ssss.gouv.qc.ca

First Name & Middle Initial & Last Name & Degree

Joannie Ruel, MD

12. IPD Sharing Statement

Plan to Share IPD

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TDM Guided Early Optimization of ADAL in Crohn's Disease

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