Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)
- Conditions
- Ankylosing Spondylitis
- Registration Number
- NCT01329380
- Lead Sponsor
- AbbVie
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 403
- Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the survey
-
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Drug Reactions 24 weeks 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 incapacityNumber of Participants With Adverse Drug Reactions by Baseline Factors 24 weeks 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 IndexNumber of Participants With Self-injection Errors 24 weeks Number of Participants With Adverse Events 24 weeks 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Markedly Improved or Improved Rating Weeks 12, 24, and at the last visit 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 assessablePercentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors 24 weeks (or last visit if earlier) 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 assessableChange From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Baseline and weeks 12 and 24 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.
Trial Locations
- Locations (193)
Teikyo University Hospital
🇯🇵板橋区, Tokyo, Japan
Ozone Surgery Clinic
🇯🇵Aichi, Japan
Asahikawa Kosei General Hosp
🇯🇵Asahikawa-shi, Japan
Asahikawa Med College Hosp, JP
🇯🇵Asahikawa, Japan
Hamanomachi Hospital
🇯🇵Fukuoka, Japan
Gifu University Hospital
🇯🇵Gifu, Japan
Kohnodai Hospital
🇯🇵Ichikawa-shi, Japan
Kaga City Hospital
🇯🇵Kaga-shi, Ishikawa, Japan
Kagoshima Univ Medical and Den
🇯🇵Kagoshima-shi, Japan
Iwate Prefectural Iwai Hosp
🇯🇵Ichinoseki-shi, Japan
Suga Orthopedic Hospital
🇯🇵Isahaya, Japan
Juntendo Univ Shizuoka Hosp
🇯🇵Izunokuni-shi, Japan
Kanazawa University Ho
🇯🇵Kanazawa, Japan
Saitama Medical University Hos
🇯🇵Iruma-gun, Japan
Isahaya Health Ins Genl Hosp
🇯🇵Isahaya, Japan
Saiseikai Kanazawa Hospital
🇯🇵Kanazawa, Japan
Asahi Hospital
🇯🇵Kasugai, Japan
Edakuni Orthopedic Clinic
🇯🇵Kiryu, Japan
Univ Occup & Environ Health
🇯🇵Kitakyushu, Japan
Kunitachi Clinic
🇯🇵Kunitachi, Japan
Kawasaki Medical School Hosp
🇯🇵Kurashiki, Japan
Kurashiki Central Hospital
🇯🇵Kurashiki, Japan
Kameda Medical Center
🇯🇵Kamogawa, Japan
Shunan Memorial Hospital
🇯🇵Kudamatsu-shi, Japan
Matsuyama Red Cross Hosp
🇯🇵Matsuyama, Japan
Kasugai Orthopaedic Clinic
🇯🇵Kasugai, Japan
NHO Osaka Minami Med Ctr
🇯🇵Kawachinagano, Japan
Jusendo General Hospital
🇯🇵Koriyama-shi, Japan
Jujo Rehabilitation Hospital
🇯🇵Kyoto, Japan
Mino Municipal Hospital
🇯🇵Mino, Japan
Miyazaki Prefectural Miyazaki
🇯🇵Miyazaki, Japan
Kyoto University Hospital
🇯🇵Sakyo-ku, Japan
Nagasawa Clinic
🇯🇵Kawagoe-shi, Japan
JR Kyushu Hospital
🇯🇵Kitakyushu, Japan
Kumamoto Rheumatology Clinic
🇯🇵Kumamoto, Japan
Kagawa University Hospital
🇯🇵Kyoto, Japan
Suzuki Orthopedic Clinic
🇯🇵Miyashiro-machi, Japan
St. Marianna Univ Hospital
🇯🇵Kawasaki, Japan
Juntendo Univ Koshigaya Hosp
🇯🇵Koshigaya, Japan
Kyoto Prefect Univ Med
🇯🇵Kyoto, Japan
JP Red Cross Kyoto Daiichi Hos
🇯🇵Kyoto, Japan
Iwasaku Orthopedic Clinic
🇯🇵Kyoto, Japan
Saiseikai Kyoto Hospital
🇯🇵Nagaokakyo, Japan
Oura Clinic
🇯🇵Naha, Japan
Iwate Medical University Hosp
🇯🇵Morioka, Japan
Noguchi Seikeigeka Naika Iin
🇯🇵Motosu-shi, Japan
Munakata Medical Assoc. Hosp.
🇯🇵Munakata-shi, Japan
Aichi Medical University Hosp
🇯🇵Nagakute, Japan
Shinseikai Daiichi Hospital
🇯🇵Nagoya, Japan
Sapporo Medical Univ Hosp
🇯🇵Sapporo, Japan
Chukyo Social Insurance Hospit
🇯🇵Nagoya-shi, Japan
Asahigaoka Hospital
🇯🇵Nara, Japan
Kin-ikyo Chuo Hospital
🇯🇵Sapporo, Japan
Kochi Medical School Hospital
🇯🇵Nankoku-shi, Japan
Mitsuka Rheumatism Clinic
🇯🇵Narashino-shi, Japan
Yoshida Internal Med Clinic
🇯🇵Tokyo, Japan
Nara City Hospital
🇯🇵Nara, Japan
Niigata City General Hospital
🇯🇵Niigata, Japan
Nirasaki City Hospital
🇯🇵Nirasaki, Japan
Nisshin Orido Hospital
🇯🇵Nisshin, Japan
Yamachika Memorial Gen Hosp
🇯🇵Odawara-shi, Japan
Sunrise Sakai Hospital
🇯🇵Oita, Japan
Ohama Daiichi Hospital
🇯🇵Okinawa, Japan
Juntendo University Hospital
🇯🇵Tokyo, Japan
Toho Univ Med Ctr Omori Hosp
🇯🇵Tokyo, Japan
Akasaka Chuo Clinic
🇯🇵Tokyo, Japan
Ishigaki Orthopedic Clinic
🇯🇵Tokyo, Japan
Ome Municipal General Hospital
🇯🇵OME, Japan
Yuri Plastic Surgery
🇯🇵ONO, Japan
Yukioka Hospital
🇯🇵Osaka, Japan
NTT WEST Osaka Hospital
🇯🇵Osaka, Japan
Osaka Rheumatology Clinic
🇯🇵Osaka-shi, Japan
Kansai Medical Univ Takii Hosp
🇯🇵Osaka, Japan
Kojima Orthopedic Clinic
🇯🇵Osaka, Japan
Murakami Orthopaedics Clinic
🇯🇵Osaka, Japan
Osaki Citizen Hospital
🇯🇵Osaki, Japan
Ota Memorial Hospital
🇯🇵OTA, Japan
Saga University Hospital
🇯🇵Saga, Japan
Osaka Rosai Hospital
🇯🇵Sakai-shi, Japan
Osaka Red Cross Hospital
🇯🇵Osaka, Japan
KKR Sapporo Med Ctr Tonan Hosp
🇯🇵Sapporo, Japan
Sasebo City General Hospital
🇯🇵Sasebo-shi, Japan
Sasebo Chuo Hospital
🇯🇵Sasebo, Japan
Tohoku University Hospital
🇯🇵Sendai, Japan
NHO Nishitaga National Hospita
🇯🇵Sendai, Japan
Jyunshinkai Inoue Hospital
🇯🇵Seto, Japan
Niigata Rheumatic Center
🇯🇵Shibata, Japan
Saiseikai Suita Hospital
🇯🇵Suita, Japan
Osaka University Hospital
🇯🇵Suita, Japan
Kotesashi Orthopedic Clinic
🇯🇵Tokorozawa-shi, Japan
Toyo Hospital
🇯🇵Tokushima-shi, Japan
Hishita-Hiasa Neurosurgery and
🇯🇵Tokushima, Japan
Kyoundo Hospital
🇯🇵Tokyo, Japan
Mitsui Memorial Hospital
🇯🇵Tokyo, Japan
Hirose Clinic
🇯🇵Tokorozawa, Japan
The Jikei University Hospital
🇯🇵Tokyo, Japan
Keiyo Hospital
🇯🇵Tokyo, Japan
Tokyo Medical University Hosp
🇯🇵Tokyo, Japan
Edogawa Hospital
🇯🇵Tokyo, Japan
Showa University Hospital
🇯🇵Tokyo, Japan
Toranomon Hospital
🇯🇵Tokyo, Japan
Tokyo Metropolitan Bokutoh Hos
🇯🇵Tokyo, Japan
Nihon University Itabashi Hosp
🇯🇵Tokyo, Japan
JP Red Cross Musashino Hosp
🇯🇵Tokyo, Japan
The University of Tokyo
🇯🇵Tokyo, Japan
Kawakita General Hospital
🇯🇵Tokyo, Japan
Toyama Prefectural Ctr Hosp
🇯🇵Toyama, Japan
Fujita Health University Hosp
🇯🇵Toyoake, Japan
Toyama University Hospital
🇯🇵Toyoma, Japan
Kishi Orthopedics Medical Clin
🇯🇵Tsuchiura-shi, Japan
Tsukuba University Hospital
🇯🇵Tsukuba, Japan
Yamaguchi Red Cross Hospital
🇯🇵Yamaguchi-shi, Japan
Tokyo Womens Med Univ Hosp
🇯🇵Tokyo, Japan
Kanamecho Hospital
🇯🇵Tokyo, Japan
Matsuda Orthopedic Rheuma Clin
🇯🇵Tokyo, Japan
NHO Disaster Medical Center
🇯🇵Tokyo, Japan
Matsuno Clinic Rheumatic Disea
🇯🇵Toyama, Japan
Daini Okamoto General Hospital
🇯🇵UJI, Japan
Shuto General Hospital
🇯🇵Yanai-shi, Japan
Tsuyama Chuo Memorial Hospital
🇯🇵Tsuyama, Japan
Wakayama Medical University
🇯🇵Wakayama, Japan
Yamagata University Hospital
🇯🇵Yamagata, Japan
Yamagata City Hosp Saiseikai
🇯🇵Yamagata, Japan
Toyooka Hospital
🇯🇵Toyooka, Japan
Kumamoto Rosai Hospital
🇯🇵Yatsushiro-shi, Japan
Showa Univ N Yokohama Hosp
🇯🇵Yokohama-shi, Japan
Tottori University Hospital
🇯🇵Yonago-shi, Japan
Hirosaki Memorial Hospital
🇯🇵Hirosaki, Japan
Shigenobu Clinic
🇯🇵Hiroshima, Japan
Teine Internal Med Rheuma Clin
🇯🇵Sapporo, Japan
NHO Iwakuni Clinical Center
🇯🇵Iwakuni-shi, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Hiroshima Clinic
🇯🇵Hiroshima-shi, Japan
Hiroshima Red Cross Hosp Atomi
🇯🇵Hiroshima, Japan
Yamana-kai Higashi Hiroshima
🇯🇵Hiroshima, Japan
Midori Hospital
🇯🇵Hyogo, Japan
Kagoshima Red Cross Hospital
🇯🇵Kagoshima, Japan
Teine Keijinkai Clinic
🇯🇵Sapporo, Japan
Kobe University Hospital
🇯🇵Kobe, Japan
Komaki Daiichi Hospital
🇯🇵Komaki, Japan
Tori Clinic
🇯🇵Maizuru-shi, Japan
NHO Nagoya Medical Center
🇯🇵Nagoya, Japan
Oita Red Cross Hospital
🇯🇵Oita, Japan
Saiseikai Hita Hospital
🇯🇵Oita, Japan
Ushio Clinic
🇯🇵Osaka-shi, Japan
Yodogawa Christian Hospital
🇯🇵Osaka-shi, Japan
Osaka Saiseikai Noe Hospital
🇯🇵Osaka, Japan
Tohoku Pharmaceutical Univ Hos
🇯🇵Sendai, Japan
National Ctr Global Health Med
🇯🇵Tokyo, Japan
Juntendo Univ Nerima Hosp
🇯🇵Tokyo, Japan
Nagoya City University Hospital
🇯🇵Nagoya-shi, Aichi, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka, Japan
Hyogo College of Medicine Hosp
🇯🇵Nishinomiya, Hyogo, Japan
Gunma University Hospital
🇯🇵Maebashi-shi, Gunma, Japan
Yokohama City Univ Medical Ctr
🇯🇵Yokohama, Kanagawa, Japan
Nagasaki University Hospital
🇯🇵長崎市, Nagasaki, Japan
Osaka City University Hospital
🇯🇵大阪市, Osaka, Japan
Okayama University Hospital
🇯🇵Okayama-shi, Okayama, Japan
Nagoya Daini Red Cross Hosp
🇯🇵Aichi, Japan
Shiga Univ Med Science Hosp
🇯🇵Otsu, Shiga, Japan
Saitama Medical Center
🇯🇵Kawagoe, Saitama, Japan
Medical Hospital of Tokyo Medical and Dental University
🇯🇵Bunkyo-ku, Tokyo, Japan
Kyorin University Hospital
🇯🇵Mitaka-shi, Tokyo, Japan
St. Luke's International Hosp
🇯🇵中央区, Tokyo, Japan
Asano Orthopedic Clinic
🇯🇵Aichi, Japan
Narushima Internal Med Clinic
🇯🇵Ami-machi, Japan
Yamagiwa Clinic
🇯🇵Aichi, Japan
Katayama Orthopedic Rheum Clin
🇯🇵Asahikawa, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Atsugi City Hospital
🇯🇵Atsugi-shi, Japan
University of Yamanashi Hosp
🇯🇵Chuo, Japan
Tama Medical Center
🇯🇵Fuchu, Japan
Fujieda Municipal General Hosp
🇯🇵Fujieda, Japan
Nakamura Clinic
🇯🇵Fukuchiyama-shi, Japan
NHO Kyushu Medical Center
🇯🇵Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka, Japan
JP Red Cross Fukuoka Hosp
🇯🇵Fukuoka, Japan
Mutaguchi Orthopedics Clinic
🇯🇵Fukuoka, Japan
PS Clinic
🇯🇵Fukuoka, Japan
Fukushima Med Univ Hosp
🇯🇵Fukushima-shi, Japan
Fukushima Red Cross Hospital
🇯🇵Fukushima, Japan
Minami Tohoku Fukushima Hosp
🇯🇵Fukushima, Japan
Seirei Mikatahara General Hosp
🇯🇵Hamamatsu, Japan
Osaka Rehabilitation Hospital
🇯🇵Hannan, Japan
Matsunami General Hospital
🇯🇵Hashima-gun, Japan
Kono Orthop. and Int. Med Clin
🇯🇵Higashimatsuyama-shi, Japan
Tama-Hokubu Medical Center
🇯🇵Higashimurayama, Japan
NHO Higashi-Ohmi Gen Med Ctr
🇯🇵Higashiomi, Japan
Yamaguchi Clinic
🇯🇵Higashiosaka-shi, Japan
Hirosaki Uni School Med & Hosp
🇯🇵Hirosaki, Japan
NHO Himeji Medical Center
🇯🇵Himeji, Japan
Higashi Hosp City of Nagoya
🇯🇵Nagoya, Japan
Kakinuma Orthopedics Clinic
🇯🇵Nagoya, Japan