History of Changes for Study: NCT01329380

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

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Study Record Versions

Version	Submitted Date	Changes
1	April 4, 2011	None (earliest Version on record)
2	May 31, 2011	Study Status and Contacts/Locations
3	September 6, 2011	Sponsor/Collaborators, Study Status and Contacts/Locations
4	December 14, 2011	Contacts/Locations and Study Status
5	January 22, 2012	Study Status
6	May 1, 2012	Study Status and Contacts/Locations
7	August 10, 2012	Contacts/Locations and Study Status
8	October 26, 2012	Contacts/Locations and Study Status
9	January 2, 2013	Contacts/Locations, Study Identification, Sponsor/Collaborators, Study Status, References and Eligibility
10	January 21, 2013	Study Status and Study Identification
11	April 12, 2013	Contacts/Locations, Study Status and Study Design
12	July 9, 2013	Contacts/Locations, Study Status, Eligibility, Study Design and Study Identification
13	October 15, 2013	Contacts/Locations and Study Status
14	January 7, 2014	Contacts/Locations and Study Status
15	April 10, 2014	Contacts/Locations and Study Status
16	July 31, 2014	Contacts/Locations and Study Status
17	October 24, 2014	Contacts/Locations and Study Status
18	February 19, 2015	Contacts/Locations and Study Status
19	April 29, 2015	Study Status and Contacts/Locations
20	August 6, 2015	Contacts/Locations and Study Status
21	November 4, 2015	Contacts/Locations, Study Status and Eligibility
22	January 27, 2016	Contacts/Locations and Study Status
23	March 15, 2016	Recruitment Status, Contacts/Locations, Study Status and Eligibility
24	April 26, 2016	Contacts/Locations, Study Status and Eligibility
25	August 3, 2016	Contacts/Locations and Study Status
26	October 28, 2016	Study Status, Contacts/Locations and Eligibility
27	January 24, 2017	Contacts/Locations and Study Status
28	April 19, 2017	Study Status and Contacts/Locations
29	July 13, 2017	Contacts/Locations and Study Status
30	October 16, 2017	Study Status and Contacts/Locations
31	January 24, 2018	Recruitment Status, Contacts/Locations, Study Status, Oversight, Study Design, Sponsor/Collaborators and IPDSharing
32	December 20, 2018	Study Status, Outcome Measures, Eligibility, Groups and Interventions, Document Section, Results, Study Design and Study Description

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	P12-764
Brief Title:	Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)
Official Title:	Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)
Secondary IDs:

Study Status


Record Verification:	January 2018
Overall Status:	Completed
Study Start:	November 29, 2010
Primary Completion:	December 31, 2017 [Actual]
Study Completion:	December 31, 2017 [Actual]

First Submitted:	March 17, 2011
First Submitted that Met QC Criteria:	April 4, 2011
First Posted:	April 5, 2011 [Estimate]

Last Update Submitted that Met QC Criteria:	January 24, 2018
Last Update Posted:	January 26, 2018 [Actual]

Sponsor/Collaborators


Sponsor:	AbbVie
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

This study of 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:

Conditions


Conditions:	Ankylosing Spondylitis
Keywords:	Ankylosing Spondylitis

Study Design


Study Type:	Observational
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	401 [Actual]
Number of Groups/Cohorts	1

Groups and Interventions

Groups/Cohorts	Interventions
Humira those with an exposure

Outcome Measures


Primary Outcome Measures:
1.	Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 12 ]
2.	Number of patients with adverse events [ Time Frame: at week 24 ] Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
3.	Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 24 ]
Secondary Outcome Measures:
1.	Effectiveness evaluation by the investigator [ Time Frame: at week 12 ] The level of improvement (markedly improved, improved, not improved, or not assessable) will be rated by comparing clinical condition at week 24 of treatment
2.	Effectiveness evaluation by the investigator [ Time Frame: at week 24 ] The level of improvement (markedly improved, improved, not improved, or not assessable) will be rated by comparing clinical condition at week 24 of treatment

Eligibility


Study Population:	All patients who receive Humira for the treatment of Ankylosing Spondylitis
Sampling Method:	Non-Probability Sample
Minimum Age:	16 Years
Maximum Age:	99 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: All patients with Ankylosing Spondylitis who are not responding well to conventional therapy and receive Humira 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

Contacts/Locations


Study Officials:	AbbVie Inc. Study Director AbbVie
Locations:	Japan
	Asano Orthopedic Clinic Aichi, Japan, 465-0097
	Nagoya Daini Red Cross Hosp Aichi, Japan
	Ozone Surgery Clinic Aichi, Japan
	Yamagiwa Clinic Aichi, Japan
	Narushima Internal Med Clinic Ami-machi, Japan, 300-1152
	Katayama Orthopedic Rheum Clin Asahikawa, Japan, 078-8243
	Asahikawa Med College Hosp, JP Asahikawa, Japan, 078-8510
	Asahikawa Kosei General Hosp Asahikawa-shi, Japan
	Atsugi City Hospital Atsugi-shi, Japan
	Chiba University Hospital Chiba, Japan, 260-8677
	University of Yamanashi Hosp Chuo, Japan, 409-3898
	Tama Medical Center Fuchu, Japan, 183-8524
	Fujieda Municipal General Hosp Fujieda, Japan, 426-8677
	Nakamura Clinic Fukuchiyama-shi, Japan
	Hamanomachi Hospital Fukuoka, Japan, 810-8539
	NHO Kyushu Medical Center Fukuoka, Japan, 810-8563
	Kyushu University Hospital Fukuoka, Japan, 812-8582
	JP Red Cross Fukuoka Hosp Fukuoka, Japan, 815-8555
	Mutaguchi Orthopedics Clinic Fukuoka, Japan
	PS Clinic Fukuoka, Japan
	Fukushima Red Cross Hospital Fukushima, Japan, 960-8530
	Minami Tohoku Fukushima Hosp Fukushima, Japan
	Fukushima Med Univ Hosp Fukushima-shi, Japan, 960-1295
	Gifu University Hospital Gifu, Japan, 501-1112
	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, 189-8511
	NHO Higashi-Ohmi Gen Med Ctr Higashiomi, Japan
	Yamaguchi Clinic Higashiosaka-shi, Japan
	NHO Himeji Medical Center Himeji, Japan, 670-8520
	Hirosaki Uni School Med & Hosp Hirosaki, Japan, 036-8560
	Hirosaki Memorial Hospital Hirosaki, Japan
	Hiroshima Red Cross Hosp Atomi Hiroshima, Japan, 730-0052
	Hiroshima University Hospital Hiroshima, Japan, 734-0037
	Yamana-kai Higashi Hiroshima Hiroshima, Japan, 739-0002
	Shigenobu Clinic Hiroshima, Japan
	Hiroshima Clinic Hiroshima-shi, Japan
	Midori Hospital Hyogo, Japan, 651-2133
	Kohnodai Hospital Ichikawa-shi, Japan, 272-8516
	Iwate Prefectural Iwai Hosp Ichinoseki-shi, Japan
	Saitama Medical University Hos Iruma-gun, Japan, 350-0451
	Suga Orthopedic Hospital Isahaya, Japan, 854-0034
	Isahaya Health Ins Genl Hosp Isahaya, Japan
	NHO Iwakuni Clinical Center Iwakuni-shi, Japan
	Juntendo Univ Shizuoka Hosp Izunokuni-shi, Japan, 410-2295
	Kaga City Hospital Kaga-shi, Ishikawa, Japan, 922-8522
	Kagoshima Red Cross Hospital Kagoshima, Japan
	Kagoshima Univ Medical and Den Kagoshima-shi, Japan
	Kameda Medical Center Kamogawa, Japan, 296-8602
	Saiseikai Kanazawa Hospital Kanazawa, Japan, 920-0353
	Kanazawa University Ho Kanazawa, Japan, 920-8641
	Kasugai Orthopaedic Clinic Kasugai, Japan, 486-0817
	Asahi Hospital Kasugai, Japan
	NHO Osaka Minami Med Ctr Kawachinagano, Japan, 586-0008
	Nagasawa Clinic Kawagoe-shi, Japan
	St. Marianna Univ Hospital Kawasaki, Japan, 216-8511
	Edakuni Orthopedic Clinic Kiryu, Japan
	JR Kyushu Hospital Kitakyushu, Japan, 800-0031
	Univ Occup & Environ Health Kitakyushu, Japan, 807-8556
	Kobe University Hospital Kobe, Japan, 650-0017
	Komaki Daiichi Hospital Komaki, Japan
	Jusendo General Hospital Koriyama-shi, Japan, 963-8585
	Juntendo Univ Koshigaya Hosp Koshigaya, Japan, 343-0032
	Shunan Memorial Hospital Kudamatsu-shi, Japan
	Kumamoto Rheumatology Clinic Kumamoto, Japan, 861-5515
	Kunitachi Clinic Kunitachi, Japan
	Kawasaki Medical School Hosp Kurashiki, Japan, 701-0114
	Kurashiki Central Hospital Kurashiki, Japan, 710-0052
	Jujo Rehabilitation Hospital Kyoto, Japan, 601-8325
	Kyoto Prefect Univ Med Kyoto, Japan, 602-8566
	JP Red Cross Kyoto Daiichi Hos Kyoto, Japan, 605-0981
	Kagawa University Hospital Kyoto, Japan, 615-8256
	Iwasaku Orthopedic Clinic Kyoto, Japan
	Tori Clinic Maizuru-shi, Japan
	Matsuyama Red Cross Hosp Matsuyama, Japan, 790-0826
	Mino Municipal Hospital Mino, Japan
	Suzuki Orthopedic Clinic Miyashiro-machi, Japan
	Miyazaki Prefectural Miyazaki Miyazaki, Japan, 880-8510
	Iwate Medical University Hosp Morioka, Japan, 020-0023
	Noguchi Seikeigeka Naika Iin Motosu-shi, Japan, 501-0446
	Munakata Medical Assoc. Hosp. Munakata-shi, Japan
	Aichi Medical University Hosp Nagakute, Japan, 480-1195
	Saiseikai Kyoto Hospital Nagaokakyo, Japan
	NHO Nagoya Medical Center Nagoya, Japan, 460-0001
	Shinseikai Daiichi Hospital Nagoya, Japan, 467-0046
	Higashi Hosp City of Nagoya Nagoya, Japan
	Kakinuma Orthopedics Clinic Nagoya, Japan
	Chukyo Social Insurance Hospit Nagoya-shi, Japan, 457-8510
	Oura Clinic Naha, Japan, 901-0145
	Kochi Medical School Hospital Nankoku-shi, Japan, 783-8505
	Nara City Hospital Nara, Japan, 530-0025
	Asahigaoka Hospital Nara, Japan
	Mitsuka Rheumatism Clinic Narashino-shi, Japan
	Niigata City General Hospital Niigata, Japan, 950-1197
	Nirasaki City Hospital Nirasaki, Japan
	Nisshin Orido Hospital Nisshin, Japan
	Ome Municipal General Hospital OME, Japan, 198-0042
	Yuri Plastic Surgery ONO, Japan
	Ota Memorial Hospital OTA, Japan, 373-8585
	Yamachika Memorial Gen Hosp Odawara-shi, Japan
	Oita Red Cross Hospital Oita, Japan, 870-0033
	Saiseikai Hita Hospital Oita, Japan
	Sunrise Sakai Hospital Oita, Japan
	Ohama Daiichi Hospital Okinawa, Japan
	Yukioka Hospital Osaka, Japan, 530-0021
	Osaka Saiseikai Noe Hospital Osaka, Japan, 536-0001
	NTT WEST Osaka Hospital Osaka, Japan, 543-0042
	Osaka Red Cross Hospital Osaka, Japan, 543-8555
	Kansai Medical Univ Takii Hosp Osaka, Japan, 570-8507
	Kojima Orthopedic Clinic Osaka, Japan
	Murakami Orthopaedics Clinic Osaka, Japan
	Osaka Rheumatology Clinic Osaka-shi, Japan
	Ushio Clinic Osaka-shi, Japan
	Yodogawa Christian Hospital Osaka-shi, Japan
	Osaki Citizen Hospital Osaki, Japan
	Saga University Hospital Saga, Japan, 849-0937
	Osaka Rosai Hospital Sakai-shi, Japan
	Yoshida Internal Med Clinic Sakaki, Japan, 389-0606
	Kyoto University Hospital Sakyo-ku, Japan, 606-8507
	Teine Internal Med Rheuma Clin Sapporo, Japan, 006-0022
	Teine Keijinkai Clinic Sapporo, Japan, 006-0811
	Sapporo Medical Univ Hosp Sapporo, Japan, 060-8543
	Kin-ikyo Chuo Hospital Sapporo, Japan
	KKR Sapporo Med Ctr Tonan Hosp Sapporo, Japan
	Sasebo Chuo Hospital Sasebo, Japan, 857-1195
	Sasebo City General Hospital Sasebo-shi, Japan
	Tohoku University Hospital Sendai, Japan, 980-0872
	NHO Nishitaga National Hospita Sendai, Japan, 982-8555
	Tohoku Pharmaceutical Univ Hos Sendai, Japan
	Jyunshinkai Inoue Hospital Seto, Japan
	Niigata Rheumatic Center Shibata, Japan, 957-0054
	Saiseikai Suita Hospital Suita, Japan, 564-0013
	Osaka University Hospital Suita, Japan, 565-0871
	Hirose Clinic Tokorozawa, Japan, 359-1111
	Kotesashi Orthopedic Clinic Tokorozawa-shi, Japan
	Hishita-Hiasa Neurosurgery and Tokushima, Japan
	Toyo Hospital Tokushima-shi, Japan
	Kyoundo Hospital Tokyo, Japan, 101-0062
	Mitsui Memorial Hospital Tokyo, Japan, 101-8643
	The Jikei University Hospital Tokyo, Japan, 105-8461
	Toranomon Hospital Tokyo, Japan, 105-8470
	The University of Tokyo Tokyo, Japan, 108-8639
	Juntendo University Hospital Tokyo, Japan, 113-8431
	Tokyo Metropolitan Bokutoh Hos Tokyo, Japan, 130-8575
	Keiyo Hospital Tokyo, Japan, 132-0025
	Toho Univ Med Ctr Omori Hosp Tokyo, Japan, 143-8541
	Tokyo Medical University Hosp Tokyo, Japan, 16000-23
	National Ctr Global Health Med Tokyo, Japan, 162-8655
	Tokyo Womens Med Univ Hosp Tokyo, Japan, 162-8666
	Kawakita General Hospital Tokyo, Japan, 166-8588
	Nihon University Itabashi Hosp Tokyo, Japan, 173-0032
	Juntendo Univ Nerima Hosp Tokyo, Japan, 177-0033
	JP Red Cross Musashino Hosp Tokyo, Japan, 180-8610
	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, Japan, 930-0138
	Toyama Prefectural Ctr Hosp Toyama, Japan, 930-0975
	Fujita Health University Hosp Toyoake, Japan, 470-1192
	Toyama University Hospital Toyoma, Japan, 930-0194
	Toyooka Hospital Toyooka, Japan, 668-8501
	Kishi Orthopedics Medical Clin Tsuchiura-shi, Japan
	Tsukuba University Hospital Tsukuba, Japan, 305-8576
	Tsuyama Chuo Memorial Hospital Tsuyama, Japan, 708-0024
	Daini Okamoto General Hospital UJI, Japan
	Wakayama Medical University Wakayama, Japan, 641-8510
	Yamagata University Hospital Yamagata, Japan, 990-9585
	Yamagata City Hosp Saiseikai Yamagata, Japan
	Yamaguchi Red Cross Hospital Yamaguchi-shi, Japan, 753-8519
	Shuto General Hospital Yanai-shi, Japan, 742-0032
	Kumamoto Rosai Hospital Yatsushiro-shi, Japan
	Showa Univ N Yokohama Hosp Yokohama-shi, Japan, 224-8503
	Tottori University Hospital Yonago-shi, Japan, 683-8504
	Japan, Aichi
	Nagoya City University Hospital Nagoya-shi, Aichi, Japan, 467-8602
	Japan, Fukuoka
	Kurume University Hospital Kurume-shi, Fukuoka, Japan, 830-0011
	Japan, Gunma
	Gunma University Hospital Maebashi-shi, Gunma, Japan, 371-8511
	Japan, Hyogo
	Hyogo College of Medicine Hosp Nishinomiya, Hyogo, Japan, 663-8501
	Japan, Kanagawa
	Yokohama City Univ Medical Ctr Yokohama, Kanagawa, Japan, 232-0024
	Japan, Nagasaki
	Nagasaki University Hospital 長崎市, Nagasaki, Japan, 〒852-8102
	Japan, Okayama
	Okayama University Hospital Okayama-shi, Okayama, Japan, 700-0914
	Japan, Osaka
	Osaka City University Hospital 大阪市, Osaka, Japan, 〒545-0051
	Japan, Saitama
	Saitama Medical Center Kawagoe, Saitama, Japan, 350-8550
	Japan, Shiga
	Shiga Univ Med Science Hosp Otsu, Shiga, Japan, 520-2192
	Japan, Tokyo
	Medical Hospital of Tokyo Medical and Dental University Bunkyo-ku, Tokyo, Japan, 113-8519
	Kyorin University Hospital Mitaka-shi, Tokyo, Japan, 181-8611
	St. Luke's International Hosp 中央区, Tokyo, Japan, 〒104-8560
	Teikyo University Hospital 板橋区, Tokyo, Japan, 〒173-8605

IPDSharing


Plan to Share IPD:	Undecided

References


Citations:
Links:	URL: http://rxabbvie.com Description: Related Info
Available IPD/Information: