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Completed

NCT Number: NCT01698307

Enhanced Algorithm for Crohn's Treatment Incorporating Early Combination Therapy

Assess if the implementation of an enhanced treatment algorithm will improve the management Crohn's Disease compared to a conventional Step-care approach.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duane Sheppard, GI Inc., Dartmouth, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Treatment Algorithm

Other

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.

Other names: Adalimumab

Conventional Step-care Algorithm

Other

Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.

Primary outcomes

  1. Risk of Crohn's Disease-related complications at two years

    Time frame: 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 outcomes

  1. Risk of Crohn's Disease-related complications, Crohn's Disease-related hospitalizations, and all cause hospitalizations at 6 months and 12 months.

    Time frame: 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.

  2. 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.

    Time frame: 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 outcomes

  1. Proportion of patients at one year and two years who are in Deep Remission without disease progression

    Time frame: 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).

  2. Proportion of patients at one year and two years who are in Deep Remission

    Time frame: 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

  3. Proportion of patients at one year and 2 years who are in Clinical Remission

    Time frame: 1 year, 2 years

    Clinical remission defined as an Harvey-Bradshaw Index (HBI) of equal to or less than 4.

  4. Change in C-reactive protein

    Time frame: 6 months, 1 year, 2 years

  5. Change in health related QoL, patient and physician global rating

    Time frame: 6 months, 1 year, 2 years

    The EuroQoL instrument [EQ-5D] will be used to measure quality of life.

  6. Patient and physician satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alimentiv Inc.

Other

Registry information

Official study title

A Cluster Randomized Controlled Trial of an Enhanced Treatment Algorithm for the Management of Crohn's Disease

Acronym: REACT2

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2012
Registry last updated
Nov 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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