CompletedNot Applicable

Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)

473 participantsStarted 2013-05-25

Plain-language summary

This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 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

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients who received 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 had 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

What they're measuring

Number of Participants With Adverse Drug Reactions

Timeframe: Up to Week 156

Trial details

NCT IDNCT01960790

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-05-15

Results submitted2018-05-03

View on ClinicalTrials.gov More Behcet's Disease trials