Crohn DiseaseNCT03261102
TDM Guided Early Optimization of ADAL in Crohn's Disease
A study testing Adalimumab in people with Crohn Disease and Drug Monitoring, run by waqqas.afif at 6 sites in Canada.
Trial summary
To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Drug Monitoring, Inflammatory Bowel Diseases
- What is being tested?
- Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesCanada
- Study dates
- 17 Jan 2017to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
University of Calgary Medical Center (UCMC)
Calgary, Alberta, T2N 4Z6
London Health Sciences Centre (LHSC) University Hospital
London, Ontario, N6A 5A5
McGill University Hospital Center (MUHC)
Montreal, Quebec, H3G 1A4
The Ottawa Hospital, IBD Centre of Excellence
Ottawa, Ontario, K1H 8L6
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1G 2E8
The University of British Columbia
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study
To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.
Read the 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.
- Conditions
- Crohn Disease, Drug Monitoring, Inflammatory Bowel Diseases
- Being tested
- Adalimumab
- Keywords
- IBD, Crohn, adalimumab, ADAL
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called Humira
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 12
Secondary outcomes (5)
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
Measured: From Week 0 to Week 12
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)
Measured: At Week 8, 12
Proportion of steroid free subjects
Steroid free defined as patients being steroid free at Week 12
Measured: At Week 12
Subjects well-being
Subjects well-being will be scored using the validated questionnaire Short inflammatory bowel disease questionnaire (SIBDQ)
Measured: From Week 0 to Week 12
Rates of complications
Rates of complications, including hospitalization, surgery, adverse reaction, and corticosteroid use.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start17 Jan 2017
- Primary completion15 Jan 2025
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- waqqas.afif
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor-investigator, waqqas.afif, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Waqqas Afif, MD, FRCPC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261102
- Sponsor's protocol ID
- MP-37-2017-2793
- Status last verified
- May 2025
- First submitted
- 22 Aug 2017
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study
- ClinicalTrials.gov ID
- NCT03261102
- Acronym / sponsor ID
- MP-37-2017-2793
- Conditions
- Crohn Disease, Drug Monitoring, Inflammatory Bowel Diseases
- Keywords
- IBD, Crohn, adalimumab, ADAL
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- waqqas.afifUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard clinical care | Active comparator | Biological: AdalimumabAdalimumab 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 |
| Active optimization | Active comparator | Biological: AdalimumabSame 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: Humira | Biological | Active optimization, Standard clinical care |
Primary outcome
Proportion of subjects who achieved remission
Time frame: Week 12
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)
5 secondary outcomes
Proportion of subjects who achieved clinical response
Time frame: From Week 0 to Week 12
Therapeutic drug monitoring
Time frame: At Week 8, 12
Proportion of steroid free subjects
Time frame: At Week 12
Subjects well-being
Time frame: From Week 0 to Week 12
Rates of complications
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waqqas Afif, MD, FRCPC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adalimumab in people with Crohn Disease and Drug Monitoring, run by waqqas.afif at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who achieved remission (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.