Behcet's DiseaseNCT01960790

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

An observational study of Behcet's Disease, run by AbbVie.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Behcet's Disease
Type of treatment: Injection or infusion
How many people: 473 participants
Where: No sites listed yet
Study dates: 25 May 2013to 15 May 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All participants who received Humira® (Adalimumab) for the treatment of Intestinal Behcet's disease

Who may be able to join

All patients who received Adalimumab for the treatment of Intestinal Behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator)

Who cannot join

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

About this study

Official title: Humira® 40mg Syringe 0.8mL Subcutaneous Injection Special Investigation 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

Conditions: Behcet's Disease
Keywords: Humira®, Behcet's Disease, Adalimumab
Medical subject headings: Behcet Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01960790
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Drug Reactions
The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed.
Measured: Up to Week 156

Secondary outcomes (6)

Global Assessment of Gastrointestinal Symptoms
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.
Measured: Up to Week 156
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
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.
Measured: Up to Week 156
Number of Participants With Cardinal Symptoms of Behcet's Disease
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.
Measured: Up to Week 156
Number of Participants With Accessory Symptoms of Behcet's Disease
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.
Measured: Up to Week 156
Number of Participants With Degree of Improvement of Endoscopic Findings
The number of participants with improvement in endoscopic findings is assessed.
Measured: Up to Week 156
Changes in C-reactive Protein (CRP)
The change in CRP from baseline through the end of the study was assessed.
Measured: Up to Week 156

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 201315 May 2017

First posted11 Oct 2013 (estimated)
Study start25 May 2013
Primary completion15 May 2017
Study completion15 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Behcet's DiseaseStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 473 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01960790
Sponsor's protocol ID: P14-152
Status last verified: May 2018
First submitted: 16 Jul 2013
Last updated: 22 Mar 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Suzuki Y, Hagiwara T, Kobayashi M, Morita K, Shimamoto T, Hibi T. Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behcet's disease: results from a large real-world observational study. Intest Res. 2021 Jul;19(3):301-312. doi: 10.5217/ir.2020.00013. Epub 2020 Aug 20.
PubMed 32814420

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Not yet recruitingPhase 2
Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
Behçet's Syndrome, Behçet's Syndrome (BS)
RecruitingPhase 2
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Behcet Syndrome, Intestinal Type
Not yet recruitingObservational study
Asprosin in Behect Patients
Behcet Disease

All Behcet's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Humira® 40mg Syringe 0.8mL Subcutaneous Injection Special Investigation in Patients With Intestinal Behcet's Disease
ClinicalTrials.gov ID: NCT01960790
Acronym / sponsor ID: P14-152
Conditions: Behcet's Disease
Keywords: Humira®, Behcet's Disease, Adalimumab
Study type: Observational
Recruitment status: Completed
Enrolment: 473 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 25 May 2013
Primary completion: 15 May 2017 (actual)
Study completion: 15 May 2017 (actual)
First posted: 11 Oct 2013 (estimated)
Results: Posted 22 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Incidence and conditions of occurrence of adverse reactions in clinical practice
Factors likely to affect the safety and effectiveness

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All participants who received Humira® (Adalimumab) for the treatment of Intestinal Behcet's disease

Key inclusion criteria (1 listed)

All patients who received Adalimumab for the treatment of Intestinal Behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator)

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

6 secondary outcomes

Global Assessment of Gastrointestinal Symptoms
Time frame: Up to Week 156
Global Assessment of Gastrointestinal Symptoms of Behcet's Disease
Time frame: Up to Week 156
Number of Participants With Cardinal Symptoms of Behcet's Disease
Time frame: Up to Week 156
Number of Participants With Accessory Symptoms of Behcet's Disease
Time frame: Up to Week 156
Number of Participants With Degree of Improvement of Endoscopic Findings
Time frame: Up to Week 156
Changes in C-reactive Protein (CRP)
Time frame: Up to Week 156

Results and safety

Results posted to the registry on 22 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Who Received Humira®	473	462

Primary outcome: Number of Participants With Adverse Drug Reactions

Time frame: Up to Week 156. Count of participants. Unit: Participants

Measure	Participants Who Received Humira® n = 462
Infections and infestations	47
Neoplasms benign, malignant and unspecified	5
Blood and lymphatic system disorders	6
Immune system disorders	1
Endocrine disorders	3
Metabolism and nutrition disorders	1
Psychiatric disorders	3
Nervous system disorders	7

Population analysed: Safety analysis set: All participants who received at least one administration of Humira® during the study (after informed consent or first administration of Humira®) and for 70 days following the last scheduled administration of Humira®.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from first dose of study drug until 70 days after the last dose of study drug (up to 156 weeks); Serious Adverse Events were collected from the time informed consent was obtained (156 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Who Received Humira®	75 of 462 (16.2%)	165 of 462 (35.7%)	4 of 462

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32814420Suzuki Y, Hagiwara T, Kobayashi M, Morita K, Shimamoto T, Hibi T. Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behcet's disease: results from a large real-world observational study. Intest Res. 2021 Jul;19(3):301-312. doi: 10.5217/ir.2020.00013. Epub 2020 Aug 20.
Related InfoLink provided by the sponsor.

Related trials for Behcet's Disease

RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Not yet recruitingPhase 2
Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
Behçet's Syndrome, Behçet's Syndrome (BS)
RecruitingPhase 2
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Behcet Syndrome, Intestinal Type
Not yet recruitingObservational study
Asprosin in Behect Patients
Behcet Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Osamu Mikami, MD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

An observational study of Behcet's Disease, run by AbbVie.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Drug Reactions (time frame: Up to Week 156). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01960790, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.