---
title: "Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )"
nct_id: NCT02896985
overall_status: COMPLETED
sponsor: AbbVie
study_type: OBSERVATIONAL
primary_condition: "Crohn's Disease"
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02896985.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02896985"
ct_last_update_post_date: 2021-03-09
last_seen_at: "2026-05-12T07:33:58.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Observational Study Evaluating the Effectiveness of Drug Concentration to Predict the Recapture of Response in Crohn's Disease Patients With Loss of Response ( PRADA )

**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)

**NCT ID:** [NCT02896985](https://clinicaltrials.gov/study/NCT02896985)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 98
- **Lead Sponsor:** AbbVie
- **Conditions:** Crohn's Disease
- **Start Date:** 2016-12-16
- **Completion Date:** 2020-03-11
- **CT.gov Last Update:** 2021-03-09

## Brief 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
```

## Arms

- **Participants with Crohn's disease** — Participants who have developed LOR to adalimumab after a minimum of 16 weeks of treatment.

## Primary Outcomes

- **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.

## 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)_

## Locations (24)

- University of Calgary /ID# 157893, Calgary, Alberta, Canada
- South Edmonton Gastroenterolog /ID# 170934, Edmonton, Alberta, Canada
- Columbia Gastro Mgmnt Ltd /ID# 152507, New Westminster, British Columbia, Canada
- GIRI Gastrointestinal Research Institute /ID# 201259, Vancouver, British Columbia, Canada
- Discovery Clinical Services /ID# 154682, Victoria, British Columbia, Canada
- Percuro Clinical Research, Ltd /ID# 202502, Victoria, British Columbia, Canada
- Winnipeg Regional Health Autho /ID# 200115, Winnipeg, Manitoba, Canada
- Dr. Everett Chalmers Reg Hosp. /ID# 171560, Fredericton, New Brunswick, Canada
- Qe Ii Hsc /Id# 152454, Halifax, Nova Scotia, Canada
- Dr. Mark Lee Medicine Professi /ID# 153127, Cambridge, Ontario, Canada
- McMaster University Med Cent /ID# 151996, Hamilton, Ontario, Canada
- London Health Sciences Centre /ID# 152508, London, Ontario, Canada
- Jeffrey So Medicine Professional Corporation /ID# 168268, Oakville, Ontario, Canada
- Taunton surgical centre /ID# 151998, Oshawa, Ontario, Canada
- The Ottawa Hospital /ID# 153771, Ottawa, Ontario, Canada
- Mount Sinai Hosp.-Toronto /ID# 155262, Toronto, Ontario, Canada
- Dr O Tarabain Medicine Prof Corp /ID# 163125, Windsor, Ontario, Canada
- CISSS de la Monteregie /ID# 162724, Greenfield Park, Quebec, Canada
- Hopital Hotel-Dieu de Levis /ID# 155493, Lévis, Quebec, Canada
- Hospital Maisonneuve-Rosemont /ID# 155184, Montreal, Quebec, Canada
- McGill Univ HC /ID# 151997, Montreal, Quebec, Canada
- Clinique MEDI-CLE /ID# 153772, Montreal, Quebec, Canada
- CIUSSS de l'Estrie - CHUS /ID# 157976, Sherbrooke, Quebec, Canada
- Royal Uni Saskatchew(CTSU) /ID# 162316, Saskatoon, Saskatchewan, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of calgary /id# 157893|calgary|alberta|canada` — added _(2026-05-12)_
- `locations.south edmonton gastroenterolog /id# 170934|edmonton|alberta|canada` — added _(2026-05-12)_
- `locations.columbia gastro mgmnt ltd /id# 152507|new westminster|british columbia|canada` — added _(2026-05-12)_
- `locations.giri gastrointestinal research institute /id# 201259|vancouver|british columbia|canada` — added _(2026-05-12)_
- `locations.discovery clinical services /id# 154682|victoria|british columbia|canada` — added _(2026-05-12)_
- `locations.percuro clinical research, ltd /id# 202502|victoria|british columbia|canada` — added _(2026-05-12)_
- `locations.winnipeg regional health autho /id# 200115|winnipeg|manitoba|canada` — added _(2026-05-12)_
- `locations.dr. everett chalmers reg hosp. /id# 171560|fredericton|new brunswick|canada` — added _(2026-05-12)_
- `locations.qe ii hsc /id# 152454|halifax|nova scotia|canada` — added _(2026-05-12)_
- `locations.dr. mark lee medicine professi /id# 153127|cambridge|ontario|canada` — added _(2026-05-12)_
- `locations.mcmaster university med cent /id# 151996|hamilton|ontario|canada` — added _(2026-05-12)_
- `locations.london health sciences centre /id# 152508|london|ontario|canada` — added _(2026-05-12)_
- `locations.jeffrey so medicine professional corporation /id# 168268|oakville|ontario|canada` — added _(2026-05-12)_
- `locations.taunton surgical centre /id# 151998|oshawa|ontario|canada` — added _(2026-05-12)_
- `locations.the ottawa hospital /id# 153771|ottawa|ontario|canada` — added _(2026-05-12)_
- `locations.mount sinai hosp.-toronto /id# 155262|toronto|ontario|canada` — added _(2026-05-12)_
- `locations.dr o tarabain medicine prof corp /id# 163125|windsor|ontario|canada` — added _(2026-05-12)_
- `locations.cisss de la monteregie /id# 162724|greenfield park|quebec|canada` — added _(2026-05-12)_
- `locations.hopital hotel-dieu de levis /id# 155493|lévis|quebec|canada` — added _(2026-05-12)_
- `locations.hospital maisonneuve-rosemont /id# 155184|montreal|quebec|canada` — added _(2026-05-12)_
- `locations.mcgill univ hc /id# 151997|montreal|quebec|canada` — added _(2026-05-12)_
- `locations.clinique medi-cle /id# 153772|montreal|quebec|canada` — added _(2026-05-12)_
- `locations.ciusss de l'estrie - chus /id# 157976|sherbrooke|quebec|canada` — added _(2026-05-12)_
- `locations.royal uni saskatchew(ctsu) /id# 162316|saskatoon|saskatchewan|canada` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02896985.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02896985*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*