Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)

Study Overview
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Brief Summary
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This study of adalimumab (Humira) will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug: Unknown adverse drug reactions (especially important adverse drug reactions) Incidence and conditions of occurrence of adverse reactions in the clinical setting Factors that may affect the safety and effectiveness of Humira

Official Title
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Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)

Conditions
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Ankylosing Spondylitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the survey Exclusion Criteria: Contraindications according to the Package Insert Patients who have serious infections Patients who have tuberculosis Patients with a history of hypersensitivity to any ingredient of Humira Patients who have demyelinating disease or with a history of demyelinating disease Patients who have congestive cardiac failure

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adalimumab<br>Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reactions | An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. A serious adverse drug reaction is any untoward medical occurrence that at any dose; Results in death Life threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent of significant disability or incapacity | 24 weeks | 
| Number of Participants With Adverse Drug Reactions by Baseline Factors | An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. ADRs are reported by baseline characteristics. NSAID: non-steroidal anti-inflammatory drug DMARD: disease-modifying anti-rheumatic drug BASDAI: Bath Ankylosing Spondylitis Disease Activity Index | 24 weeks | 
| Number of Participants With Adverse Events | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. | 24 weeks | 
| Number of Participants With Self-injection Errors |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Markedly Improved or Improved Rating | Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale: 1. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable | Weeks 12, 24, and at the last visit | 
| Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale: 1. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable | 24 weeks (or last visit if earlier) | 
| Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity. | Baseline and weeks 12 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankylosing Spondylitis