Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)
Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)
1 other identifier
observational
403
1 country
194
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Longer than P75 for all trials
194 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2010
CompletedFirst Submitted
Initial submission to the registry
March 17, 2011
CompletedFirst Posted
Study publicly available on registry
April 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2017
CompletedResults Posted
Study results publicly available
April 3, 2019
CompletedApril 3, 2019
December 1, 2018
7.2 years
March 17, 2011
December 20, 2018
December 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
Number of Participants With Markedly Improved or Improved Rating
Weeks 12, 24, and at the last visit
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
24 weeks (or last visit if earlier)
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Baseline and weeks 12 and 24
Study Arms (1)
Adalimumab
Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.
Eligibility Criteria
All patients who receive Humira for the treatment of ankylosing spondylitis
You may qualify if:
- Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the survey
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (194)
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
Hyogo College of Medicine Hosp
Nishinomiya, Hyōgo, 663-8501, Japan
Yokohama City Univ Medical Ctr
Yokohama, Kanagawa, 232-0024, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 〒852-8102, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-0914, Japan
Osaka City University Hospital
Osaka, Osaka, 〒545-0051, Japan
Saitama Medical Center
Kawagoe, Saitama, 350-8550, Japan
Shiga Univ Med Science Hosp
Ōtsu, Shiga, 520-2192, Japan
Medical Hospital of Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, 113-8519, Japan
St. Luke's International Hosp
Chūō, Tokyo, 〒104-8560, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, 181-8611, Japan
Teikyo University Hospital
板橋区, Tokyo, 〒173-8605, Japan
Asano Orthopedic Clinic
Aichi, 465-0097, Japan
Nagoya Daini Red Cross Hosp
Aichi, Japan
Ozone Surgery Clinic
Aichi, Japan
Yamagiwa Clinic
Aichi, Japan
Narushima Internal Med Clinic
Ami-machi, 300-1152, Japan
Katayama Orthopedic Rheum Clin
Asahikawa, 078-8243, Japan
Asahikawa Med College Hosp, JP
Asahikawa, 078-8510, Japan
Asahikawa Kosei General Hosp
Asahikawa-shi, Japan
Atsugi City Hospital
Atsugi-shi, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
University of Yamanashi Hosp
Chūō, 409-3898, Japan
Tama Medical Center
Fuchū, 183-8524, Japan
Fujieda Municipal General Hosp
Fujieda, 426-8677, Japan
Nakamura Clinic
Fukuchiyama-shi, Japan
Hamanomachi Hospital
Fukuoka, 810-8539, Japan
NHO Kyushu Medical Center
Fukuoka, 810-8563, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
JP Red Cross Fukuoka Hosp
Fukuoka, 815-8555, Japan
Mutaguchi Orthopedics Clinic
Fukuoka, Japan
PS Clinic
Fukuoka, Japan
Fukushima Med Univ Hosp
Fukushima, 960-1295, Japan
Fukushima Red Cross Hospital
Fukushima, 960-8530, Japan
Minami Tohoku Fukushima Hosp
Fukushima, Japan
Gifu University Hospital
Gifu, 501-1112, 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, 189-8511, Japan
Yamaguchi Clinic
Higashiosaka-shi, Japan
NHO Higashi-Ohmi Gen Med Ctr
Higashiōmi, Japan
NHO Himeji Medical Center
Himeji, 670-8520, Japan
Hirosaki Uni School Med & Hosp
Hirosaki, 036-8560, Japan
Hirosaki Memorial Hospital
Hirosaki, Japan
Hiroshima Red Cross Hosp Atomi
Hiroshima, 730-0052, Japan
Hiroshima University Hospital
Hiroshima, 734-0037, Japan
Yamana-kai Higashi Hiroshima
Hiroshima, 739-0002, Japan
Hiroshima Clinic
Hiroshima, Japan
Shigenobu Clinic
Hiroshima, Japan
Midori Hospital
Hyōgo, 651-2133, Japan
Kohnodai Hospital
Ichikawa-shi, 272-8516, Japan
Iwate Prefectural Iwai Hosp
Ichinoseki-shi, Japan
Saitama Medical University Hos
Iruma-gun, 350-0451, Japan
Suga Orthopedic Hospital
Isahaya, 854-0034, Japan
Isahaya Health Ins Genl Hosp
Isahaya, Japan
NHO Iwakuni Clinical Center
Iwakuni-shi, Japan
Juntendo Univ Shizuoka Hosp
Izunokuni-shi, 410-2295, Japan
Kaga City Hospital
Kaga-shi, Ishikawa, 922-8522, Japan
Kagoshima Red Cross Hospital
Kagoshima, Japan
Kagoshima Univ Medical and Den
Kagoshima, Japan
Kameda Medical Center
Kamogawa, 296-8602, Japan
Saiseikai Kanazawa Hospital
Kanazawa, 920-0353, Japan
Kanazawa University Ho
Kanazawa, 920-8641, Japan
Kasugai Orthopaedic Clinic
Kasugai, 486-0817, Japan
Asahi Hospital
Kasugai, Japan
NHO Osaka Minami Med Ctr
Kawachi-Nagano, 586-0008, Japan
Nagasawa Clinic
Kawagoe-shi, Japan
St. Marianna Univ Hospital
Kawasaki, 216-8511, Japan
Edakuni Orthopedic Clinic
Kiryū, Japan
JR Kyushu Hospital
Kitakyushu, 800-0031, Japan
Univ Occup & Environ Health
Kitakyushu, 807-8556, Japan
Kobe University Hospital
Kobe, 650-0017, Japan
Komaki Daiichi Hospital
Komaki, Japan
Jusendo General Hospital
Koriyama-shi, 963-8585, Japan
Juntendo Univ Koshigaya Hosp
Koshigaya, 343-0032, Japan
Saiseikai Kyoto Hospital
Kōtari, Japan
Shunan Memorial Hospital
Kudamatsu-shi, Japan
Kumamoto Rheumatology Clinic
Kumamoto, 861-5515, Japan
Kunitachi Clinic
Kunitachi, Japan
Kawasaki Medical School Hosp
Kurashiki, 701-0114, Japan
Kurashiki Central Hospital
Kurashiki, 710-0052, Japan
Jujo Rehabilitation Hospital
Kyoto, 601-8325, Japan
Kyoto Prefect Univ Med
Kyoto, 602-8566, Japan
JP Red Cross Kyoto Daiichi Hos
Kyoto, 605-0981, Japan
Kagawa University Hospital
Kyoto, 615-8256, Japan
Iwasaku Orthopedic Clinic
Kyoto, Japan
Tori Clinic
Maizuru-shi, Japan
Matsuyama Red Cross Hosp
Matsuyama, 790-0826, Japan
Mino Municipal Hospital
Mino, Japan
Suzuki Orthopedic Clinic
Miyashiro-machi, Japan
Miyazaki Prefectural Miyazaki
Miyazaki, 880-8510, Japan
Iwate Medical University Hosp
Morioka, 020-0023, Japan
Noguchi Seikeigeka Naika Iin
Motosu-shi, 501-0446, Japan
Munakata Medical Assoc. Hosp.
Munakata-shi, Japan
Aichi Medical University Hosp
Nagakute, 480-1195, Japan
Chukyo Social Insurance Hospit
Nagoya, 457-8510, Japan
NHO Nagoya Medical Center
Nagoya, 460-0001, Japan
Shinseikai Daiichi Hospital
Nagoya, 467-0046, Japan
Higashi Hosp City of Nagoya
Nagoya, Japan
Kakinuma Orthopedics Clinic
Nagoya, Japan
Oura Clinic
Naha, 901-0145, Japan
Kochi Medical School Hospital
Nankoku-shi, 783-8505, Japan
Nara City Hospital
Nara, 530-0025, Japan
Asahigaoka Hospital
Nara, Japan
Mitsuka Rheumatism Clinic
Narashino-shi, Japan
Niigata City General Hospital
Niigata, 950-1197, Japan
Nirasaki City Hospital
Nirasaki, Japan
Nisshin Orido Hospital
Nisshin, Japan
Yamachika Memorial Gen Hosp
Odawara-shi, Japan
Ohama Daiichi Hospital
Okinawa, Japan
Yuri Plastic Surgery
Ono, Japan
Yukioka Hospital
Osaka, 530-0021, Japan
Osaka Saiseikai Noe Hospital
Osaka, 536-0001, Japan
NTT WEST Osaka Hospital
Osaka, 543-0042, Japan
Osaka Red Cross Hospital
Osaka, 543-8555, Japan
Kansai Medical Univ Takii Hosp
Osaka, 570-8507, Japan
Kojima Orthopedic Clinic
Osaka, Japan
Murakami Orthopaedics Clinic
Osaka, Japan
Osaka Rheumatology Clinic
Osaka, Japan
Ushio Clinic
Osaka, Japan
Yodogawa Christian Hospital
Osaka, Japan
Oita Red Cross Hospital
Ōita, 870-0033, Japan
Saiseikai Hita Hospital
Ōita, Japan
Sunrise Sakai Hospital
Ōita, Japan
Ome Municipal General Hospital
Ōme, 198-0042, Japan
Osaki Citizen Hospital
Ōsaki, Japan
Ota Memorial Hospital
Ōta-ku, 373-8585, Japan
Saga University Hospital
Saga, 849-0937, Japan
Osaka Rosai Hospital
Sakaishi, Japan
Yoshida Internal Med Clinic
Sakaki, 389-0606, Japan
Kyoto University Hospital
Sakyo-ku, 606-8507, Japan
Teine Internal Med Rheuma Clin
Sapporo, 006-0022, Japan
Teine Keijinkai Clinic
Sapporo, 006-0811, Japan
Sapporo Medical Univ Hosp
Sapporo, 060-8543, Japan
Kin-ikyo Chuo Hospital
Sapporo, Japan
KKR Sapporo Med Ctr Tonan Hosp
Sapporo, Japan
Sasebo Chuo Hospital
Sasebo, 857-1195, Japan
Sasebo City General Hospital
Sasebo-shi, Japan
Tohoku University Hospital
Sendai, 980-0872, Japan
NHO Nishitaga National Hospita
Sendai, 982-8555, Japan
Tohoku Pharmaceutical Univ Hos
Sendai, Japan
Jyunshinkai Inoue Hospital
Seto, Japan
Niigata Rheumatic Center
Shibata, 957-0054, Japan
Saiseikai Suita Hospital
Suita, 564-0013, Japan
Osaka University Hospital
Suita, 565-0871, Japan
Hirose Clinic
Tokorozawa, 359-1111, Japan
Kotesashi Orthopedic Clinic
Tokorozawa-shi, Japan
Hishita-Hiasa Neurosurgery and
Tokushima, Japan
Toyo Hospital
Tokushima, Japan
Kyoundo Hospital
Tokyo, 101-0062, Japan
Mitsui Memorial Hospital
Tokyo, 101-8643, Japan
The Jikei University Hospital
Tokyo, 105-8461, Japan
Toranomon Hospital
Tokyo, 105-8470, Japan
The University of Tokyo
Tokyo, 108-8639, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Tokyo Metropolitan Bokutoh Hos
Tokyo, 130-8575, Japan
Keiyo Hospital
Tokyo, 132-0025, Japan
Toho Univ Med Ctr Omori Hosp
Tokyo, 143-8541, Japan
Tokyo Medical University Hosp
Tokyo, 16000-23, Japan
National Ctr Global Health Med
Tokyo, 162-8655, Japan
Tokyo Womens Med Univ Hosp
Tokyo, 162-8666, Japan
Kawakita General Hospital
Tokyo, 166-8588, Japan
Nihon University Itabashi Hosp
Tokyo, 173-0032, Japan
Juntendo Univ Nerima Hosp
Tokyo, 177-0033, Japan
JP Red Cross Musashino Hosp
Tokyo, 180-8610, Japan
Akasaka Chuo Clinic
Tokyo, Japan
Edogawa Hospital
Tokyo, Japan
Ishigaki Orthopedic Clinic
Tokyo, Japan
Kanamecho Hospital
Tokyo, Japan
Matsuda Orthopedic Rheuma Clin
Tokyo, Japan
NHO Disaster Medical Center
Tokyo, Japan
Showa University Hospital
Tokyo, Japan
Yoshida Internal Med Clinic
Tokyo, Japan
Matsuno Clinic Rheumatic Disea
Toyama, 930-0138, Japan
Toyama Prefectural Ctr Hosp
Toyama, 930-0975, Japan
Fujita Health University Hosp
Toyoake, 470-1192, Japan
Toyama University Hospital
Toyoma, 930-0194, Japan
Toyooka Hospital
Toyooka, 668-8501, Japan
Kishi Orthopedics Medical Clin
Tsuchiura-shi, Japan
Tsukuba University Hospital
Tsukuba, 305-8576, Japan
Tsuyama Chuo Memorial Hospital
Tsuyama, 708-0024, Japan
Daini Okamoto General Hospital
Uji, Japan
Wakayama Medical University
Wakayama, 641-8510, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Yamagata City Hosp Saiseikai
Yamagata, Japan
Yamaguchi Red Cross Hospital
Yamaguchi, 753-8519, Japan
Shuto General Hospital
Yanai-shi, 742-0032, Japan
Kumamoto Rosai Hospital
Yatsushiro-shi, Japan
Showa Univ N Yokohama Hosp
Yokohama, 224-8503, Japan
Tottori University Hospital
Yonago-shi, 683-8504, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2011
First Posted
April 5, 2011
Study Start
October 27, 2010
Primary Completion
December 28, 2017
Study Completion
December 28, 2017
Last Updated
April 3, 2019
Results First Posted
April 3, 2019
Record last verified: 2018-12