Crohn's Disease
Conditions
Keywords
Crohn's Disease, Deep Remission, Complications
Brief summary
Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach.
Detailed description
Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract. During disease exacerbations, pharmacological or surgical intervention is usually needed to re-establish remission. Ideally, strategies should be employed to maintain patients in long-term remission while minimizing exposure to corticosteroids and reduce therapy-related toxicity. Nevertheless, in reality many patients with CD do not receive effective therapy and their disease often remains active, leading to uncontrolled inflammation and complications from either the underlying disease or corticosteroids.
Interventions
The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
OTHERConventional Step-care Algorithm
Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.
Sponsors
Alimentiv Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
algorithm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented diagnosis of CD * Written informed consent must be obtained and documented. * Willing to utilize study supply of adalimumab provided in syringe format, if indicated according to treatment algorithm.
Exclusion criteria
* Any conditions (e.g., history of alcohol or substance abuse) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures. * Latex allergy or other conditions in which adalimumab syringes are contraindicated * Currently participating, or planning to participate in a study involving investigational product within 24 months that may interfere with the patient's ability to comply with study procedures. * Previously failed all classes of tumor necrosis factor (TNF) antagonists for the treatment of CD. * Diagnosis of short bowel syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of Crohn's Disease-related complications at two years | 2 years | Crohn''s Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months. | six months, 12 months | Crohn's Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures. |
| Time to first Crohn's Disease-related complication, first Crohn's Disease-related hospitalizations, and first all cause hospitalizations at 6 months and 12 months. | six months, 12 months | Crohn's Disease (CD)-related complications include (1) CD-related surgeries and non-surgical CD events (such as disease flare, bowel obstruction, and bowel damage events (such as symptomatic bowel obstruction, fistula, abscess and CD related hospitalizations and 2) complications and hospitalizations related to CD medications or procedures. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in C-reactive protein | 6 months, 1 year, 2 years | — |
| Proportion of patients at one year and two years who are in Deep Remission without disease progression | 1 year, 2 years | Disease progression is defined as the de novo development of strictures or fistula, the occurrence of an intra-abdominal abscess, or surgery for Crohn's Disease (resection, bypass, stricturoplasty). |
| Patient and physician satisfaction | 2 years | At the completion of study participation, subjects and physicians in both treatment groups will be asked to complete a satisfaction questionnaire regarding the information provided and their overall satisfaction with the approach to the management of CD. The physicians will also be asked if they would recommend the CD treatment algorithm to their colleagues, and if they think it would be feasible to sustain this algorithm within their practice setting. |
| Change in health related QoL, patient and physician global rating | 6 months, 1 year, 2 years | The EuroQoL instrument \[EQ-5D\] will be used to measure quality of life. |
| Proportion of patients at one year and two years who are in Deep Remission | 1 year, 2 years | Deep remission defined as a Harvey-Bradshaw Index (HBI) less than or equal to 4, no steriods for the treatment of Crohn's Disease, and normal C-reactive protein |
| Proportion of patients at one year and 2 years who are in Clinical Remission | 1 year, 2 years | Clinical remission defined as an Harvey-Bradshaw Index (HBI) of equal to or less than 4. |
Countries
Canada, Germany, United Kingdom, United States
Outcome results
None listed