Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD

NCT03059849 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2831
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To examine whether a temporary three month increase in adalimumab dosing will prevent relapse in patients with inflammatory bowel disease in clinical remission who have elevated calprotectin.

Conditions

Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Number of patients with clinical relapse

  Clinical relapse will be based on increased clinical symptoms or endoscopic changes requiring use of corticosteroids, addition of an immunomodulator, change to another biologic therapy, or surgery.

  One year

Study Arms (2)

Temporary increase in adalimumab

ACTIVE COMPARATOR

Drug: Adalimumab

Continued monitoring as per standard of care

NO INTERVENTION

Interventions

Adalimumab DRUG

Dose of adalimumab will be increased by 40mg every 2 weeks.

Temporary increase in adalimumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18 and older with Crohn's disease and ulcerative colitis
• Patients are in clinical remission according to the last 'Abbvie Care' clinical symptom assessment (using Partial Mayo score \< 2 or Harvey-Bradshaw Index \< 4)
• Patient using adalimumab at a dose of at least 40mg subcutaneously bi-weekly, and at a maximum dose of 40mg subcutaneously weekly (or 80mg subcutaneously bi-weekly).

You may not qualify if:

• Abdominal abscess
• Inability or unwillingness to provide informed consent
• Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 23, 2017
• Study Start: February 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share