- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01960790
Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)
December 19, 2018 updated by: AbbVie
Humira® 40mg Syringe 0.8mL Subcutaneous Injection Special Investigation in Patients With Intestinal Behcet's Disease
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.
- Incidence and conditions of occurrence of adverse reactions in clinical practice
- Factors likely to affect the safety and effectiveness
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
473
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All participants who received Humira® (Adalimumab) for the treatment of Intestinal Behcet's disease
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Participants who received Humira®
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Drug Reactions
Time Frame: Up to Week 156
|
The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed.
|
Up to Week 156
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Assessment of Gastrointestinal Symptoms
Time Frame: Up to Week 156
|
Study participants completed a global assessment of their gastrointestinal symptoms on a 5-grade scale.
Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life.
|
Up to Week 156
|
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Time Frame: Up to Week 156
|
Study participants completed a global assessment of their gastrointestinal symptoms (including abdominal pain, diarrhea and other gastrointestinal symptoms such as abdominal distension, abdominal tenderness, and hemorrhage) on a 5-grade scale.
Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life.
|
Up to Week 156
|
Number of Participants With Cardinal Symptoms of Behcet's Disease
Time Frame: Up to Week 156
|
The presence or absence of symptoms including recurrent aphthous ulcers of oral mucosa, cutaneous symptoms, eye symptoms and ulceration of vulva was assessed at weeks 52, 104 and 156 against presence or absence at baseline.
|
Up to Week 156
|
Number of Participants With Accessory Symptoms of Behcet's Disease
Time Frame: Up to Week 156
|
The presence or absence of symptoms including arthritis without deformity or stiffness, epididymitis, vascular lesions and moderate to severe central nervous system (CNS) lesions was assessed at weeks 52, 104 and 156 against presence or absence at baseline.
|
Up to Week 156
|
Number of Participants With Degree of Improvement of Endoscopic Findings
Time Frame: Up to Week 156
|
The number of participants with improvement in endoscopic findings is assessed.
|
Up to Week 156
|
Changes in C-reactive Protein (CRP)
Time Frame: Up to Week 156
|
The change in CRP from baseline through the end of the study was assessed.
|
Up to Week 156
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Osamu Mikami, MD, AbbVie GK.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 25, 2013
Primary Completion (Actual)
May 15, 2017
Study Completion (Actual)
May 15, 2017
Study Registration Dates
First Submitted
July 16, 2013
First Submitted That Met QC Criteria
October 10, 2013
First Posted (Estimate)
October 11, 2013
Study Record Updates
Last Update Posted (Actual)
March 22, 2019
Last Update Submitted That Met QC Criteria
December 19, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P14-152
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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