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
Study Type
OBSERVATIONAL
Enrollment
403
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
Time frame: 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
Time frame: 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.
Time frame: 24 weeks
Number of Participants With Self-injection Errors
Time frame: 24 weeks
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Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Hyogo College of Medicine Hosp
Nishinomiya, Hyōgo, Japan
Yokohama City Univ Medical Ctr
Yokohama, Kanagawa, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Osaka City University Hospital
Osaka, Osaka, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Shiga Univ Med Science Hosp
Ōtsu, Shiga, Japan
...and 184 more locations
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
Time frame: 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
Time frame: 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.
Time frame: Baseline and weeks 12 and 24