Overview

This trial is active, not recruiting.

Condition behcet's disease
Sponsor AbbVie
Start date July 2013
End date April 2017
Trial size 250 participants
Trial identifier NCT01960790, P14-152

Summary

This investigation will be conducted to obtain the following information regarding the use of Adalimumab 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease.

1. Incidence and conditions of occurrence of adverse reactions in clinical practice

2. Factors likely to affect the safety and effectiveness

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Humira® 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration

Primary Outcomes

Measure
Number of patients with adverse events
time frame: Up to Week 156

Secondary Outcomes

Measure
Number of patients with overall evaluation of gastrointestinal symptoms
time frame: Up to Week 156
Number of patients with evaluation of symptoms of Behcet's disease
time frame: Up to Week 156
Number of patients with degree of improvement of endoscopic findings
time frame: Up to Week 156
C-reactive Protein
time frame: Up to Week 156

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - All patients who receive Adalimumab for the treatment of Intestinal Behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator) Exclusion Criteria: Contraindications according to the Package Insert include patients who have any of the following: - serious infections - tuberculosis - a history of hypersensitivity to any ingredient of Humira® - demyelinating disease or a history of demyelinating disease - congestive cardiac failure

Additional Information

Official title Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.