Crohn's DiseasePRADANCT02896985
Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )
An observational study of Crohn's Disease, run by AbbVie at 24 sites in Canada.
Trial summary
This is a multi-center study that explores the relationship between recapture of response with escalation to weekly adalimumab and trough adalimumab concentration before escalation in patients experiencing lack of response (LOR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 98 participants
- Where
- 24 sitesCanada
- Study dates
- 16 Dec 2016to 11 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Participants will be enrolled from approximately 15 to 20 investigative sites in Canada where such Therapeutic Drug Monitoring/Anti-Adalimumab Antibody (TDM/AAA) testing at the point of patient LOR and pre-dose escalation to Every Week (EW) occurs.
Who may be able to join
- Documented diagnosis of Crohn's Disease.
- Treatment with adalimumab, for a minimum of 16 weeks, as per clinical practice, at a dose of 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w with a documented response as defined by the investigator.
- Current evidence of active inflammatory disease/LOR defined as the presence of active inflammation (confirmed with a CRP ≥ 5 mg/L and/or a fecal calprotectin ≥ 250µg/g.
- Ability of subject to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented.
Who cannot join
- Primary non-responders to 16 weeks of adalimumab therapy.
- Received any investigational drug within the 16 weeks of adalimumab therapy.
- Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
- History of alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
- Stools positive for Clostridium difficile.
- Pregnant or lactating women.
- Current enrolment in any other interventional research study.
- Presence of perianal or abdominal abscess.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Canada24 sites
University of Calgary /ID# 157893
Calgary, Alberta, T2N 4Z6
Dr. Mark Lee Medicine Professi /ID# 153127
Cambridge, Ontario, N1R 0B6
South Edmonton Gastroenterolog /ID# 170934
Edmonton, Alberta, T6L 6K3
Dr. Everett Chalmers Reg Hosp. /ID# 171560
Fredericton, New Brunswick, E3B 5N5
CISSS de la Monteregie /ID# 162724
Greenfield Park, Quebec, J4V 2H1
Qe Ii Hsc /Id# 152454
Halifax, Nova Scotia, B3H 1V7
McMaster University Med Cent /ID# 151996
Hamilton, Ontario, L8S 4K1
Hopital Hotel-Dieu de Levis /ID# 155493
Lévis, Quebec, G6V 3Z1
London Health Sciences Centre /ID# 152508
London, Ontario, N6A 5A5
Hospital Maisonneuve-Rosemont /ID# 155184
Montreal, Quebec, H1T 2M4
McGill Univ HC /ID# 151997
Montreal, Quebec, H3G 1A4
Clinique MEDI-CLE /ID# 153772
Montreal, Quebec, H3P 3E5
Columbia Gastro Mgmnt Ltd /ID# 152507
New Westminster, British Columbia, V3L 3W5
Jeffrey So Medicine Professional Corporation /ID# 168268
Oakville, Ontario, L6M 4J2
Taunton surgical centre /ID# 151998
Oshawa, Ontario, L1H 7K4
The Ottawa Hospital /ID# 153771
Ottawa, Ontario, K1H 8L6
Royal Uni Saskatchew(CTSU) /ID# 162316
Saskatoon, Saskatchewan, S7N 0W8
CIUSSS de l'Estrie - CHUS /ID# 157976
Sherbrooke, Quebec, J1G 2E8
Mount Sinai Hosp.-Toronto /ID# 155262
Toronto, Ontario, M5G 1X5
GIRI Gastrointestinal Research Institute /ID# 201259
Vancouver, British Columbia, V6Z 2K5
Discovery Clinical Services /ID# 154682
Victoria, British Columbia, V8T 5G4
Percuro Clinical Research, Ltd /ID# 202502
Victoria, British Columbia, V8V 3M9
Dr O Tarabain Medicine Prof Corp /ID# 163125
Windsor, Ontario, N8W 1E6
Winnipeg Regional Health Autho /ID# 200115
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: A Cohort Study to Evaluate the Effectiveness of Drug Concentrations in Predicting Recapture of Response With Weekly ADAlimumab in Crohn's Disease Subjects With Secondary Loss of Response (PRADA)
This is a multi-center study that explores the relationship between recapture of response with escalation to weekly adalimumab and trough adalimumab concentration before escalation in patients experiencing lack of response (LOR).
- Conditions
- Crohn's Disease
- Keywords
- Patient Reported Outcome 2 (PRO 2), C-Reactive Protein (CRP), Adalimumab, Harvey Bradshaw Index (HBI), Therapeutic Drug Monitoring (TDM), Anti-Adalimumab Antibody (AAA)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Crohn's disease | Participants who have developed LOR to adalimumab after a minimum of 16 weeks of treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the relationship between drug concentration at baseline and recapture of response
Logistic regression analysis will be used to model the relationship between drug concentration at baseline and recapture of response.
Measured: At Week 12
Secondary outcomes (8)
Explore the relationship between trough adalimumab concentrations at baseline and change in patient reported outcome 2 (PRO2)
Covariance analysis is used.
Measured: From Week 0 to Week 12
Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP)
Covariance analysis is used.
Measured: From Week 0 to Week 12
Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin
Covariance analysis is used.
Measured: From Week 0 to Week 12
Proportion of participants requiring steroids or additional therapy
Assessing participants that require steroids or additional therapy
Measured: Up to Week 12
Proportion of participants with 50% drop from screening in CRP or calprotectin
Assessing participants with 50% drop in CRP or calprotectin.
Measured: At Week 12
Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations
Covariance analysis is used.
Measured: At Week 12
Proportion of participants with clinical remission PRO2 < 8
PRO2 was developed based on FDA guidance for use of patient reported outcomes.
Measured: At Week 12
Proportion of participants with normalization of CRP or fecal calprotectin
Assessing participants with normalization of CRP (<5mg/dl) or fecal calprotectin (<150ug/ml)
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start16 Dec 2016
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896985
- Sponsor's protocol ID
- P15-770
- Acronym
- PRADA
- Status last verified
- Mar 2021
- First submitted
- 7 Sep 2016
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Marco D, McHugh K, Plamondon S, Rioux LC, Steinhart AH, Horvat M, Afif W. An observational cohort study evaluating adalimumab concentrations for predicting non-recapture of biochemical response after dose escalation in patients with Crohn's disease experiencing secondary loss of response. J Can Assoc Gastroenterol. 2026 Feb 18;9(3):153-161. doi: 10.1093/jcag/gwag002. eCollection 2026 Jun.
PubMed 42244850
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study to Evaluate the Effectiveness of Drug Concentrations in Predicting Recapture of Response With Weekly ADAlimumab in Crohn's Disease Subjects With Secondary Loss of Response (PRADA)
- ClinicalTrials.gov ID
- NCT02896985
- Acronym / sponsor ID
- PRADA / P15-770
- Conditions
- Crohn's Disease
- Keywords
- Patient Reported Outcome 2 (PRO 2), C-Reactive Protein (CRP), Adalimumab, Harvey Bradshaw Index (HBI), Therapeutic Drug Monitoring (TDM), Anti-Adalimumab Antibody (AAA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 12 Sep 2016 (estimated)
- 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.
This is a multi-center study that explores the relationship between recapture of response with escalation to weekly adalimumab and trough adalimumab concentration before escalation in patients experiencing lack of response (LOR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Crohn's disease | – | –Participants who have developed LOR to adalimumab after a minimum of 16 weeks of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be enrolled from approximately 15 to 20 investigative sites in Canada where such Therapeutic Drug Monitoring/Anti-Adalimumab Antibody (TDM/AAA) testing at the point of patient LOR and pre-dose escalation to Every Week (EW) occurs.
Key inclusion criteria (5 listed)
- Documented diagnosis of Crohn's Disease.
- Treatment with adalimumab, for a minimum of 16 weeks, as per clinical practice, at a dose of 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w with a documented response as defined by the investigator.
- Current evidence of active inflammatory disease/LOR defined as the presence of active inflammation (confirmed with a CRP ≥ 5 mg/L and/or a fecal calprotectin ≥ 250µg/g.
- Ability of subject to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented.
Key exclusion criteria (8 listed)
- Primary non-responders to 16 weeks of adalimumab therapy.
- Received any investigational drug within the 16 weeks of adalimumab therapy.
- Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
- History of alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
- Stools positive for Clostridium difficile.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Explore the relationship between drug concentration at baseline and recapture of response
Time frame: At Week 12
Logistic regression analysis will be used to model the relationship between drug concentration at baseline and recapture of response.
8 secondary outcomes
Explore the relationship between trough adalimumab concentrations at baseline and change in patient reported outcome 2 (PRO2)
Time frame: From Week 0 to Week 12
Explore the relationship between trough adalimumab concentrations at baseline and change in C-reactive protein (CRP)
Time frame: From Week 0 to Week 12
Explore the relationship between trough adalimumab concentrations at baseline and change in fecal calprotectin
Time frame: From Week 0 to Week 12
Proportion of participants requiring steroids or additional therapy
Time frame: Up to Week 12
Proportion of participants with 50% drop from screening in CRP or calprotectin
Time frame: At Week 12
Explore the relationship between changes in HBI between screening and final trough adalimumab concentrations
Time frame: At Week 12
Proportion of participants with clinical remission PRO2 < 8
Time frame: At Week 12
Proportion of participants with normalization of CRP or fecal calprotectin
Time frame: At Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Derived from this study: PubMed 42244850De Marco D, McHugh K, Plamondon S, Rioux LC, Steinhart AH, Horvat M, Afif W. An observational cohort study evaluating adalimumab concentrations for predicting non-recapture of biochemical response after dose escalation in patients with Crohn's disease experiencing secondary loss of response. J Can Assoc Gastroenterol. 2026 Feb 18;9(3):153-161. doi: 10.1093/jcag/gwag002. eCollection 2026 Jun.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
AbbVie Inc. study director
AbbVie
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by AbbVie at 24 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Explore the relationship between drug concentration at baseline and recapture of response (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02896985, which also lists 1 linked publication.
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 9 Mar 2021.