Behcet's Disease
Conditions
Keywords
Humira®, Behcet's Disease, Adalimumab
Brief 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
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | Up to Week 156 | The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | 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. |
| Number of Participants With Degree of Improvement of Endoscopic Findings | Up to Week 156 | The number of participants with improvement in endoscopic findings is assessed. |
| Global Assessment of Gastrointestinal Symptoms | 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. |
| Number of Participants With Accessory Symptoms of Behcet's Disease | 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. |
| Changes in C-reactive Protein (CRP) | Up to Week 156 | The change in CRP from baseline through the end of the study was assessed. |
| Number of Participants With Cardinal Symptoms of Behcet's Disease | 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. |
Participant flow
Pre-assignment details
A total of 473 participants were enrolled in the study; 462 participants were analyzed for safety and 383 participants were analyzed for efficacy.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 462 |
| Total | 462 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Survey forms could not be recovered | 3 |
| Overall Study | Transferred to another hospital | 4 |
| Overall Study | Treat with Humira outside survey period | 3 |
| Overall Study | Unevaluable for safety | 1 |
Baseline characteristics
| Characteristic | Participants Who Received Humira® |
|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 17.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 461 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 225 Participants |
| Sex: Female, Male Male | 236 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 462 |
| other Total, other adverse events | 165 / 462 |
| serious Total, serious adverse events | 75 / 462 |
Outcome results
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.
Time frame: Up to Week 156
Population: 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®.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Infections and infestations | 47 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Eye disorders | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Vascular disorders | 5 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Respiratory, thoracic and mediastinal disorders | 9 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Gastrointestinal Disorders | 20 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Hepatobiliary disorders | 4 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Skin and subcutaneous tissue disorder | 6 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Neoplasms benign, malignant and unspecified | 5 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Blood and lymphatic system disorders | 6 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Immune system disorders | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Endocrine disorders | 3 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Metabolism and nutrition disorders | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Psychiatric disorders | 3 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Nervous system disorders | 7 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Musculoskeletal and connective tissue disorder | 9 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Pregnancy, puerperium and perinatal conditions | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | General disorders and adminstration site condition | 19 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Investigations | 22 Participants |
| Participants Who Received Humira® | Number of Participants With Adverse Drug Reactions | Injury, poisoning and procedural complications | 1 Participants |
Secondary
Changes in C-reactive Protein (CRP)
The change in CRP from baseline through the end of the study was assessed.
Time frame: Up to Week 156
Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Received Humira® | Changes in C-reactive Protein (CRP) | Baseline | 2.0239 mg/dL | Standard Deviation 3.4242 |
| Participants Who Received Humira® | Changes in C-reactive Protein (CRP) | Week 24 | 0.5389 mg/dL | Standard Deviation 1.515 |
| Participants Who Received Humira® | Changes in C-reactive Protein (CRP) | Week 52 | 0.5504 mg/dL | Standard Deviation 1.4651 |
| Participants Who Received Humira® | Changes in C-reactive Protein (CRP) | Week 76 | 0.3348 mg/dL | Standard Deviation 0.8126 |
| Participants Who Received Humira® | Changes in C-reactive Protein (CRP) | Week 104 | 0.4031 mg/dL | Standard Deviation 1.1279 |
| Participants Who Received Humira® | Changes in C-reactive Protein (CRP) | Week 128 | 0.5034 mg/dL | Standard Deviation 2.5356 |
| Participants Who Received Humira® | Changes in C-reactive Protein (CRP) | Week 156 | 0.2246 mg/dL | Standard Deviation 0.5808 |
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.
Time frame: Up to Week 156
Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Baseline | Global assessment score = 1 | 55 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Baseline | Global assessment score = 2 | 76 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 4 | Global assessment score = 1 | 85 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 4 | Global assessment score = 2 | 44 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 4 | Global assessment score = 3 | 33 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 4 | Global assessment score = 4 | 8 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 8 | Global assessment score = 0 | 176 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 12 | Global assessment score = 0 | 169 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 12 | Global assessment score = 1 | 72 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 24 | Global assessment score = 2 | 34 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 24 | Global assessment score = 3 | 8 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 52 | Global assessment score = 0 | 142 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 52 | Global assessment score = 1 | 45 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 52 | Global assessment score = 2 | 22 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 76 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 104 | Global assessment score = 0 | 113 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 104 | Global assessment score = 1 | 39 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 104 | Global assessment score = 2 | 17 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 156 | Global assessment score = 0 | 32 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 156 | Global assessment score = 1 | 8 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 156 | Global assessment score = 2 | 9 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 156 | Global assessment score = 3 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Baseline | Global assessment score = 0 | 52 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Baseline | Global assessment score = 3 | 88 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Baseline | Global assessment score = 4 | 98 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 4 | Global assessment score = 0 | 153 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 8 | Global assessment score = 1 | 72 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 8 | Global assessment score = 2 | 38 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 8 | Global assessment score = 3 | 19 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 8 | Global assessment score = 4 | 10 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 12 | Global assessment score = 2 | 32 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 12 | Global assessment score = 3 | 12 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 12 | Global assessment score = 4 | 7 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 24 | Global assessment score = 0 | 152 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 24 | Global assessment score = 1 | 44 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 24 | Global assessment score = 4 | 2 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 52 | Global assessment score = 3 | 10 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 52 | Global assessment score = 4 | 2 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 76 | Global assessment score = 0 | 112 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 76 | Global assessment score = 1 | 38 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 76 | Global assessment score = 2 | 18 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 76 | Global assessment score = 3 | 8 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 104 | Global assessment score = 3 | 3 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 104 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 128 | Global assessment score = 0 | 29 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 128 | Global assessment score = 1 | 12 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 128 | Global assessment score = 2 | 8 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 128 | Global assessment score = 3 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 128 | Global assessment score = 4 | 1 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms | Week 156 | Global assessment score = 4 | 0 Participants |
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.
Time frame: Up to Week 156
Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 0 (baseline) | Global assessment score = 3 | 82 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 4 | Global assessment score = 0 | 181 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 4 | Global assessment score = 4 | 6 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 8 | Global assessment score = 3 | 20 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 12 | Global assessment score = 3 | 13 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 12 | Global assessment score = 4 | 6 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 24 | Global assessment score = 0 | 174 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 24 | Global assessment score = 1 | 28 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 24 | Global assessment score = 2 | 29 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 24 | Global assessment score = 3 | 6 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 76 | Global assessment score = 0 | 129 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 76 | Global assessment score = 1 | 26 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 104 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 8 | Global assessment score = 3 | 7 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 8 | Global assessment score = 4 | 3 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 12 | Global assessment score = 2 | 26 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 76 | Global assessment score = 0 | 131 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 4 | Global assessment score = 2 | 31 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 12 | Global assessment score = 2 | 21 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 24 | Global assessment score = 0 | 188 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 76 | Global assessment score = 2 | 13 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 76 | Global assessment score = 4 | 1 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 0 (baseline) | Global assessment score = 0 | 89 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 0 (baseline) | Global assessment score = 1 | 56 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 0 (baseline) | Global assessment score = 2 | 74 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 0 (baseline) | Global assessment score = 4 | 67 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 4 | Global assessment score = 1 | 69 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 4 | Global assessment score = 2 | 39 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 4 | Global assessment score = 3 | 27 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 8 | Global assessment score = 0 | 202 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 8 | Global assessment score = 1 | 59 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 8 | Global assessment score = 2 | 28 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 8 | Global assessment score = 4 | 5 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 12 | Global assessment score = 0 | 193 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 12 | Global assessment score = 1 | 54 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 12 | Global assessment score = 2 | 26 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 24 | Global assessment score = 4 | 2 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 52 | Global assessment score = 0 | 158 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 52 | Global assessment score = 1 | 31 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 52 | Global assessment score = 2 | 21 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 52 | Global assessment score = 3 | 10 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 52 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 76 | Global assessment score = 2 | 14 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 76 | Global assessment score = 3 | 8 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 76 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 104 | Global assessment score = 0 | 132 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 104 | Global assessment score = 1 | 31 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 104 | Global assessment score = 2 | 8 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 104 | Global assessment score = 3 | 2 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 128 | Global assessment score = 0 | 36 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 128 | Global assessment score = 1 | 8 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 128 | Global assessment score = 2 | 4 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 128 | Global assessment score = 3 | 1 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 128 | Global assessment score = 4 | 1 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 156 | Global assessment score = 0 | 36 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 156 | Global assessment score = 1 | 5 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 156 | Global assessment score = 2 | 8 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 156 | Global assessment score = 3 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Abdominal pain at week 156 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 0 (baseline) | Global assessment score = 0 | 167 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 0 (baseline) | Global assessment score = 1 | 61 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 0 (baseline) | Global assessment score = 2 | 54 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 0 (baseline) | Global assessment score = 3 | 50 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 0 (baseline) | Global assessment score = 4 | 36 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 4 | Global assessment score = 0 | 226 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 4 | Global assessment score = 1 | 52 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 4 | Global assessment score = 2 | 27 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 4 | Global assessment score = 3 | 14 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 4 | Global assessment score = 4 | 3 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 8 | Global assessment score = 0 | 232 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 8 | Global assessment score = 1 | 54 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 8 | Global assessment score = 2 | 18 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 12 | Global assessment score = 0 | 221 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 12 | Global assessment score = 1 | 37 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 12 | Global assessment score = 3 | 5 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 12 | Global assessment score = 4 | 3 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 24 | Global assessment score = 0 | 181 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 24 | Global assessment score = 1 | 35 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 24 | Global assessment score = 2 | 21 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 24 | Global assessment score = 3 | 2 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 24 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 52 | Global assessment score = 0 | 176 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 52 | Global assessment score = 1 | 28 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 52 | Global assessment score = 2 | 12 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 52 | Global assessment score = 3 | 4 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 52 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 76 | Global assessment score = 1 | 31 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 76 | Global assessment score = 2 | 10 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 76 | Global assessment score = 3 | 5 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 76 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 104 | Global assessment score = 0 | 135 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 104 | Global assessment score = 1 | 26 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 104 | Global assessment score = 2 | 10 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 104 | Global assessment score = 3 | 2 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 104 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 128 | Global assessment score = 0 | 36 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 128 | Global assessment score = 1 | 11 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 128 | Global assessment score = 2 | 3 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 128 | Global assessment score = 3 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 128 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 156 | Global assessment score = 0 | 37 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 156 | Global assessment score = 1 | 8 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 156 | Global assessment score = 2 | 4 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 156 | Global assessment score = 3 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Diarrhoea at week 156 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 0/baseline | Global assessment score = 0 | 124 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 0/baseline | Global assessment score = 1 | 54 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 0/baseline | Global assessment score = 2 | 61 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 0/baseline | Global assessment score = 3 | 68 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 0/baseline | Global assessment score = 4 | 61 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 4 | Global assessment score = 0 | 219 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 4 | Global assessment score = 1 | 49 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 4 | Global assessment score = 3 | 16 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 4 | Global assessment score = 4 | 7 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 8 | Global assessment score = 0 | 226 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 8 | Global assessment score = 1 | 44 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 8 | Global assessment score = 2 | 27 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 8 | Global assessment score = 3 | 10 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 8 | Global assessment score = 4 | 7 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 12 | Global assessment score = 0 | 220 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 12 | Global assessment score = 1 | 40 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 12 | Global assessment score = 3 | 7 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 12 | Global assessment score = 4 | 4 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 24 | Global assessment score = 1 | 28 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 24 | Global assessment score = 2 | 19 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 24 | Global assessment score = 3 | 2 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 24 | Global assessment score = 4 | 2 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 52 | Global assessment score = 0 | 172 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 52 | Global assessment score = 1 | 26 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 52 | Global assessment score = 2 | 15 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 52 | Global assessment score = 3 | 6 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 52 | Global assessment score = 4 | 1 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 76 | Global assessment score = 0 | 138 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 76 | Global assessment score = 1 | 20 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 76 | Global assessment score = 3 | 5 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 104 | Global assessment score = 0 | 143 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 104 | Global assessment score = 1 | 17 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 104 | Global assessment score = 2 | 10 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 104 | Global assessment score = 3 | 3 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 104 | Global assessment score = 4 | 0 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 128 | Global assessment score = 0 | 36 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 128 | Global assessment score = 1 | 11 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 128 | Global assessment score = 2 | 1 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 128 | Global assessment score = 3 | 1 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 128 | Global assessment score = 4 | 1 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 156 | Global assessment score = 0 | 37 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 156 | Global assessment score = 1 | 7 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 156 | Global assessment score = 2 | 4 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 156 | Global assessment score = 3 | 1 Participants |
| Participants Who Received Humira® | Global Assessment of Gastrointestinal Symptoms of Behcet's Disease | Other gastrointestinal symptoms at week 156 | Global assessment score = 4 | 0 Participants |
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.
Time frame: Up to Week 156
Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 156 | Assessment absence and baseline presence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 52 | Assessment absence and baseline absence | 150 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 52 | Assessment absence and baseline presence | 39 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 52 | Assessment presence and baseline absence | 11 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 52 | Assessment presence and baseline presence | 21 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 104 | Assessment absence and baseline absence | 115 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 104 | Assessment absence and baseline presence | 36 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 104 | Assessment presence and baseline absence | 14 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 104 | Assessment presence and baseline presence | 9 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 156 | Assessment absence and baseline absence | 30 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 156 | Assessment absence and baseline presence | 14 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 156 | Assessment presence and baseline absence | 5 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Arthritis without deformity/ stiffness at week 156 | Assessment presence and baseline presence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 52 | Assessment absence and baseline absence | 219 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 52 | Assessment absence and baseline presence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 52 | Assessment presence and baseline absence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 52 | Assessment presence and baseline presence | 2 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 104 | Assessment absence and baseline absence | 172 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 104 | Assessment absence and baseline presence | 2 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 104 | Assessment presence and baseline absence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 104 | Assessment presence and baseline presence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 156 | Assessment absence and baseline absence | 46 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 156 | Assessment absence and baseline presence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 156 | Assessment presence and baseline absence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Epididymitis at week 156 | Assessment presence and baseline presence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 52 | Assessment absence and baseline absence | 213 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 52 | Assessment absence and baseline presence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 52 | Assessment presence and baseline absence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 52 | Assessment presence and baseline presence | 7 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 104 | Assessment absence and baseline absence | 168 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 104 | Assessment absence and baseline presence | 4 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 104 | Assessment presence and baseline absence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 104 | Assessment presence and baseline presence | 2 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 156 | Assessment absence and baseline absence | 47 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 156 | Assessment absence and baseline presence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 156 | Assessment presence and baseline absence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Vascular lesions at week 156 | Assessment presence and baseline presence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 52 | Assessment absence and baseline absence | 217 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 52 | Assessment absence and baseline presence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 52 | Assessment presence and baseline absence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 52 | Assessment presence and baseline presence | 2 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 104 | Assessment absence and baseline absence | 171 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 104 | Assessment absence and baseline presence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 104 | Assessment presence and baseline absence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 104 | Assessment presence and baseline presence | 2 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 156 | Assessment absence and baseline absence | 48 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 156 | Assessment presence and baseline absence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Accessory Symptoms of Behcet's Disease | Moderate to severe CNS lesions at week 156 | Assessment presence and baseline presence | 0 Participants |
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.
Time frame: Up to Week 156
Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcers of oral mucosa at week52 | Assessment absence and baseline presence | 84 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcers of oral mucosa at week52 | Assessment absence and baseline absence | 99 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcers of oral mucosa at week52 | Assessment presence and baseline absence | 7 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcers of oral mucosa at week52 | Assessment presence and baseline presence | 29 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcer of oral mucosa at week104 | Assessment absence and baseline absence | 74 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcer of oral mucosa at week104 | Assessment absence and baseline presence | 59 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcer of oral mucosa at week104 | Assessment presence and baseline absence | 13 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcer of oral mucosa at week104 | Assessment presence and baseline presence | 26 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcer of oral mucosa at week156 | Assessment absence and baseline absence | 27 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcer of oral mucosa at week156 | Assessment absence and baseline presence | 12 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcer of oral mucosa at week156 | Assessment presence and baseline absence | 5 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Recurrent aphthous ulcer of oral mucosa at week156 | Assessment presence and baseline presence | 5 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 52 | Assessment absence and baseline absence | 147 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 52 | Assessment absence and baseline presence | 56 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 52 | Assessment presence and baseline absence | 5 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 52 | Assessment presence and baseline presence | 11 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 104 | Assessment absence and baseline absence | 123 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 104 | Assessment absence and baseline presence | 34 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 104 | Assessment presence and baseline absence | 7 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 104 | Assessment presence and baseline presence | 9 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 156 | Assessment absence and baseline absence | 32 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 156 | Assessment absence and baseline presence | 13 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 156 | Assessment presence and baseline absence | 4 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Cutaneous symptoms at week 156 | Assessment presence and baseline presence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 52 | Assessment absence and baseline absence | 216 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 52 | Assessment absence and baseline presence | 3 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 52 | Assessment presence and baseline absence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 52 | Assessment presence and baseline presence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 104 | Assessment absence and baseline absence | 168 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 104 | Assessment absence and baseline presence | 4 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 104 | Assessment presence and baseline absence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 104 | Assessment presence and baseline presence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 156 | Assessment absence and baseline absence | 48 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 156 | Assessment absence and baseline presence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 156 | Assessment presence and baseline absence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Eye symptoms at week 156 | Assessment presence and baseline presence | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 52 | Assessment absence and baseline absence | 184 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 52 | Assessment absence and baseline presence | 27 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 52 | Assessment presence and baseline absence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 52 | Assessment presence and baseline presence | 8 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 104 | Assessment absence and baseline absence | 151 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 104 | Assessment absence and baseline presence | 14 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 104 | Assessment presence and baseline absence | 4 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 104 | Assessment presence and baseline presence | 4 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 156 | Assessment absence and baseline absence | 42 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 156 | Assessment absence and baseline presence | 5 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 156 | Assessment presence and baseline absence | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Cardinal Symptoms of Behcet's Disease | Ulceration of vulva at week 156 | Assessment presence and baseline presence | 1 Participants |
Secondary
Number of Participants With Degree of Improvement of Endoscopic Findings
The number of participants with improvement in endoscopic findings is assessed.
Time frame: Up to Week 156
Population: All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 24 to < Week 52 | Unchanged | 12 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 24 to < Week 52 | Diminished in size | 29 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Baseline to < Week 24 | Cured or scarring | 64 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 24 to < Week 52 | Cured or scarring | 73 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 128 to < Week 160 | Diminished in size | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 128 to < Week 160 | Unchanged | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 128 to < Week 160 | Aggravated | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 128 to < Week 160 | Unassessable | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Baseline to < Week 24 | Diminished in size | 38 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Baseline to < Week 24 | Unchanged | 24 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 104 to < Week 128 | Unassessable | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Baseline to < Week 24 | Aggravated | 9 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Baseline to < Week 24 | Unassessable | 2 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 24 to < Week 52 | Aggravated | 6 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 24 to < Week 52 | Unassessable | 8 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 52 to < Week 76 | Cured or scarring | 42 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 52 to < Week 76 | Diminished in size | 6 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 52 to < Week 76 | Unchanged | 9 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 52 to < Week 76 | Aggravated | 0 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 52 to < Week 76 | Unassessable | 3 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 76 to < Week 104 | Cured or scarring | 29 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 76 to < Week 104 | Diminished in size | 6 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 76 to < Week 104 | Unchanged | 7 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 76 to < Week 104 | Aggravated | 5 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 76 to < Week 104 | Unassessable | 2 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 104 to < Week 128 | Cured or scarring | 16 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 104 to < Week 128 | Diminished in size | 3 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 104 to < Week 128 | Unchanged | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 104 to < Week 128 | Aggravated | 1 Participants |
| Participants Who Received Humira® | Number of Participants With Degree of Improvement of Endoscopic Findings | Week 128 to < Week 160 | Cured or scarring | 9 Participants |