NCT03261102

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

8 years

First QC Date

August 22, 2017

Last Update Submit

May 21, 2025

Conditions

Crohn DiseaseDrug MonitoringInflammatory Bowel Diseases

Keywords

IBDCrohnadalimumabADAL

Outcome Measures

Primary Outcomes (1)

  • 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)

    Week 12

Secondary Outcomes (5)

  • Proportion of subjects who achieved clinical response

    From Week 0 to Week 12

  • Therapeutic drug monitoring

    At Week 8, 12

  • Proportion of steroid free subjects

    At Week 12

  • Subjects well-being

    From Week 0 to Week 12

  • Rates of complications

    12 weeks

Study Arms (2)

Standard clinical care

ACTIVE COMPARATOR

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

Biological: Adalimumab

Active optimization

ACTIVE COMPARATOR

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

Biological: Adalimumab

Interventions

AdalimumabBIOLOGICAL
Also known as: Humira
Active optimizationStandard clinical care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Calgary Medical Center (UCMC)

Calgary, Alberta, T2N 4Z6, Canada

Location

The University of British Columbia

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

London Health Sciences Centre (LHSC) University Hospital

London, Ontario, N6A 5A5, Canada

Location

The Ottawa Hospital, IBD Centre of Excellence

Ottawa, Ontario, K1H 8L6, Canada

Location

McGill University Hospital Center (MUHC)

Montreal, Quebec, H3G 1A4, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1G 2E8, Canada

Location

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Waqqas Afif, MD, FRCPC

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Some of the participants, care providers and investigators will eventually, in the course of the study, have knowledge of the arm they were assigned.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Waqqas Afif MD, FRCPC

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 24, 2017

Study Start

January 17, 2017

Primary Completion

January 15, 2025

Study Completion

June 1, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(6)