Behcet's Disease Clinical Trial
Official title:
Humira® 40mg Syringe 0.8mL Subcutaneous Injection Special Investigation in Patients With Intestinal Behcet's Disease
NCT number | NCT01960790 |
Other study ID # | P14-152 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 25, 2013 |
Est. completion date | May 15, 2017 |
Verified date | May 2018 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 473 |
Est. completion date | May 15, 2017 |
Est. primary completion date | May 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Adverse Drug Reactions | The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed. | Up to Week 156 | |
Secondary | 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. | Up to Week 156 | |
Secondary | 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. | Up to Week 156 | |
Secondary | 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. | Up to Week 156 | |
Secondary | 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. | Up to Week 156 | |
Secondary | Number of Participants With Degree of Improvement of Endoscopic Findings | The number of participants with improvement in endoscopic findings is assessed. | Up to Week 156 | |
Secondary | Changes in C-reactive Protein (CRP) | The change in CRP from baseline through the end of the study was assessed. | Up to Week 156 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05635266 -
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
|
||
Completed |
NCT02190916 -
Vasculitis Illness Perception (VIP) Study
|
N/A | |
Completed |
NCT04065672 -
Low-dose IL-2 Treatment on Behcet's Disease
|
Phase 2 | |
Recruiting |
NCT02593565 -
Vasculitis Pregnancy Registry
|
||
Completed |
NCT00167583 -
Interferon-alpha2a Versus Cyclosporin A for Severe Ocular Behcet`s Disease (INCYTOB)
|
Phase 3 | |
Completed |
NCT03371095 -
Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease
|
Phase 3 | |
Completed |
NCT03531385 -
Assessment of Central Sensitization, Neuropathic Pain, Sleep Quality and Daily Life Activities in Behcet's Disease
|
||
Completed |
NCT02190942 -
VCRC Patient Contact Registry Patient-Reported Data Validation Study
|
||
Completed |
NCT04328064 -
The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease
|
N/A | |
Not yet recruiting |
NCT06285539 -
Drug Rediscovery for Rare Immune Mediated Inflammatory Diseases
|
Phase 2 | |
Completed |
NCT02190929 -
Educational Needs of Patients With Systemic Vasculitis
|
N/A | |
Completed |
NCT02476292 -
Impact of Vasculitis on Employment and Income
|
N/A | |
Completed |
NCT03543709 -
Evaluation of Fibromyalgia With Disease Activity and Clinical Findings in Women With Behçet's Disease
|
||
Recruiting |
NCT01793168 -
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
|
||
Completed |
NCT01988506 -
Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases
|
Phase 2 | |
Recruiting |
NCT01952275 -
Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases
|
N/A | |
Completed |
NCT01532570 -
Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions
|
Phase 3 | |
Completed |
NCT03410290 -
Journey of Patients With Vasculitis From First Symptom to Diagnosis
|
||
Completed |
NCT02176070 -
Reproductive Health in Men and Women With Vasculitis
|
N/A | |
Recruiting |
NCT01306955 -
The Efficacy of Methylprednisolone in the Treatment of Patients With Ocular Involvement in Behcet's Disease
|
Phase 4 |