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Ankylosing SpondylitisNCT01329380

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

An observational study of Ankylosing Spondylitis, run by AbbVie at 194 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 99 years
Conditions the study is for
Ankylosing Spondylitis
How many people
403 participants
Where
194 sitesJapan
Study dates
27 Oct 2010to 28 Dec 2017
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients who receive Humira for the treatment of ankylosing spondylitis

Who may be able to join

  • Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the survey

Who cannot join

  • 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

Trial locations and contacts

194 sites in 1 country.

194 sites in 1 country

Japan194 sites

  • Asano Orthopedic Clinic

    Aichi, 465-0097

  • Nagoya Daini Red Cross Hosp

    Aichi

  • Ozone Surgery Clinic

    Aichi

  • Yamagiwa Clinic

    Aichi

  • Narushima Internal Med Clinic

    Ami-machi, 300-1152

  • Katayama Orthopedic Rheum Clin

    Asahikawa, 078-8243

  • Asahikawa Med College Hosp, JP

    Asahikawa, 078-8510

  • Asahikawa Kosei General Hosp

    Asahikawa-shi

  • Atsugi City Hospital

    Atsugi-shi

  • Medical Hospital of Tokyo Medical and Dental University

    Bunkyo-ku, Tokyo, 113-8519

  • Chiba University Hospital

    Chiba, 260-8677

  • St. Luke's International Hosp

    Chūō, Tokyo, 〒104-8560

  • University of Yamanashi Hosp

    Chūō, 409-3898

  • Tama Medical Center

    Fuchū, 183-8524

  • Fujieda Municipal General Hosp

    Fujieda, 426-8677

  • Nakamura Clinic

    Fukuchiyama-shi

  • Hamanomachi Hospital

    Fukuoka, 810-8539

  • NHO Kyushu Medical Center

    Fukuoka, 810-8563

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • JP Red Cross Fukuoka Hosp

    Fukuoka, 815-8555

  • Mutaguchi Orthopedics Clinic

    Fukuoka

  • PS Clinic

    Fukuoka

  • Fukushima Med Univ Hosp

    Fukushima, 960-1295

  • Fukushima Red Cross Hospital

    Fukushima, 960-8530

  • Minami Tohoku Fukushima Hosp

    Fukushima

  • Gifu University Hospital

    Gifu, 501-1112

  • Seirei Mikatahara General Hosp

    Hamamatsu

  • Osaka Rehabilitation Hospital

    Hannan

  • Matsunami General Hospital

    Hashima-gun

  • Kono Orthop. and Int. Med Clin

    Higashimatsuyama-shi

  • Tama-Hokubu Medical Center

    Higashimurayama, 189-8511

  • NHO Higashi-Ohmi Gen Med Ctr

    Higashiōmi

  • Yamaguchi Clinic

    Higashiosaka-shi

  • NHO Himeji Medical Center

    Himeji, 670-8520

  • Hirosaki Uni School Med & Hosp

    Hirosaki, 036-8560

  • Hirosaki Memorial Hospital

    Hirosaki

  • Hiroshima Red Cross Hosp Atomi

    Hiroshima, 730-0052

  • Hiroshima University Hospital

    Hiroshima, 734-0037

  • Yamana-kai Higashi Hiroshima

    Hiroshima, 739-0002

  • Hiroshima Clinic

    Hiroshima

  • Shigenobu Clinic

    Hiroshima

  • Midori Hospital

    Hyōgo, 651-2133

  • Kohnodai Hospital

    Ichikawa-shi, 272-8516

  • Iwate Prefectural Iwai Hosp

    Ichinoseki-shi

  • Saitama Medical University Hos

    Iruma-gun, 350-0451

  • Suga Orthopedic Hospital

    Isahaya, 854-0034

  • Isahaya Health Ins Genl Hosp

    Isahaya

  • NHO Iwakuni Clinical Center

    Iwakuni-shi

  • Juntendo Univ Shizuoka Hosp

    Izunokuni-shi, 410-2295

  • Kaga City Hospital

    Kaga-shi, Ishikawa, 922-8522

  • Kagoshima Red Cross Hospital

    Kagoshima

  • Kagoshima Univ Medical and Den

    Kagoshima

  • Kameda Medical Center

    Kamogawa, 296-8602

  • Saiseikai Kanazawa Hospital

    Kanazawa, 920-0353

  • Kanazawa University Ho

    Kanazawa, 920-8641

  • Kasugai Orthopaedic Clinic

    Kasugai, 486-0817

  • Asahi Hospital

    Kasugai

  • NHO Osaka Minami Med Ctr

    Kawachi-Nagano, 586-0008

  • Saitama Medical Center

    Kawagoe, Saitama, 350-8550

  • Nagasawa Clinic

    Kawagoe-shi

  • St. Marianna Univ Hospital

    Kawasaki, 216-8511

  • Edakuni Orthopedic Clinic

    Kiryū

  • JR Kyushu Hospital

    Kitakyushu, 800-0031

  • Univ Occup & Environ Health

    Kitakyushu, 807-8556

  • Kobe University Hospital

    Kobe, 650-0017

  • Komaki Daiichi Hospital

    Komaki

  • Jusendo General Hospital

    Koriyama-shi, 963-8585

  • Juntendo Univ Koshigaya Hosp

    Koshigaya, 343-0032

  • Saiseikai Kyoto Hospital

    Kōtari

  • Shunan Memorial Hospital

    Kudamatsu-shi

  • Kumamoto Rheumatology Clinic

    Kumamoto, 861-5515

  • Kunitachi Clinic

    Kunitachi

  • Kawasaki Medical School Hosp

    Kurashiki, 701-0114

  • Kurashiki Central Hospital

    Kurashiki, 710-0052

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • Jujo Rehabilitation Hospital

    Kyoto, 601-8325

  • Kyoto Prefect Univ Med

    Kyoto, 602-8566

  • JP Red Cross Kyoto Daiichi Hos

    Kyoto, 605-0981

  • Kagawa University Hospital

    Kyoto, 615-8256

  • Iwasaku Orthopedic Clinic

    Kyoto

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Tori Clinic

    Maizuru-shi

  • Matsuyama Red Cross Hosp

    Matsuyama, 790-0826

  • Mino Municipal Hospital

    Mino

  • Kyorin University Hospital

    Mitaka-shi, Tokyo, 181-8611

  • Suzuki Orthopedic Clinic

    Miyashiro-machi

  • Miyazaki Prefectural Miyazaki

    Miyazaki, 880-8510

  • Iwate Medical University Hosp

    Morioka, 020-0023

  • Noguchi Seikeigeka Naika Iin

    Motosu-shi, 501-0446

  • Munakata Medical Assoc. Hosp.

    Munakata-shi

  • Aichi Medical University Hosp

    Nagakute, 480-1195

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 〒852-8102

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Chukyo Social Insurance Hospit

    Nagoya, 457-8510

  • NHO Nagoya Medical Center

    Nagoya, 460-0001

  • Shinseikai Daiichi Hospital

    Nagoya, 467-0046

  • Higashi Hosp City of Nagoya

    Nagoya

  • Kakinuma Orthopedics Clinic

    Nagoya

  • Oura Clinic

    Naha, 901-0145

  • Kochi Medical School Hospital

    Nankoku-shi, 783-8505

  • Nara City Hospital

    Nara, 530-0025

  • Asahigaoka Hospital

    Nara

  • Mitsuka Rheumatism Clinic

    Narashino-shi

  • Niigata City General Hospital

    Niigata, 950-1197

  • Nirasaki City Hospital

    Nirasaki

  • Hyogo College of Medicine Hosp

    Nishinomiya, Hyōgo, 663-8501

  • Nisshin Orido Hospital

    Nisshin

  • Yamachika Memorial Gen Hosp

    Odawara-shi

  • Oita Red Cross Hospital

    Ōita, 870-0033

  • Saiseikai Hita Hospital

    Ōita

  • Sunrise Sakai Hospital

    Ōita

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-0914

  • Ohama Daiichi Hospital

    Okinawa

  • Ome Municipal General Hospital

    Ōme, 198-0042

  • Yuri Plastic Surgery

    Ono

  • Osaka City University Hospital

    Osaka, Osaka, 〒545-0051

  • Yukioka Hospital

    Osaka, 530-0021

  • Osaka Saiseikai Noe Hospital

    Osaka, 536-0001

  • NTT WEST Osaka Hospital

    Osaka, 543-0042

  • Osaka Red Cross Hospital

    Osaka, 543-8555

  • Kansai Medical Univ Takii Hosp

    Osaka, 570-8507

  • Kojima Orthopedic Clinic

    Osaka

  • Murakami Orthopaedics Clinic

    Osaka

  • Osaka Rheumatology Clinic

    Osaka

  • Ushio Clinic

    Osaka

  • Yodogawa Christian Hospital

    Osaka

  • Osaki Citizen Hospital

    Ōsaki

  • Ota Memorial Hospital

    Ōta-ku, 373-8585

  • Shiga Univ Med Science Hosp

    Ōtsu, Shiga, 520-2192

  • Saga University Hospital

    Saga, 849-0937

  • Osaka Rosai Hospital

    Sakaishi

  • Yoshida Internal Med Clinic

    Sakaki, 389-0606

  • Kyoto University Hospital

    Sakyo-ku, 606-8507

  • Teine Internal Med Rheuma Clin

    Sapporo, 006-0022

  • Teine Keijinkai Clinic

    Sapporo, 006-0811

  • Sapporo Medical Univ Hosp

    Sapporo, 060-8543

  • Kin-ikyo Chuo Hospital

    Sapporo

  • KKR Sapporo Med Ctr Tonan Hosp

    Sapporo

  • Sasebo Chuo Hospital

    Sasebo, 857-1195

  • Sasebo City General Hospital

    Sasebo-shi

  • Tohoku University Hospital

    Sendai, 980-0872

  • NHO Nishitaga National Hospita

    Sendai, 982-8555

  • Tohoku Pharmaceutical Univ Hos

    Sendai

  • Jyunshinkai Inoue Hospital

    Seto

  • Niigata Rheumatic Center

    Shibata, 957-0054

  • Saiseikai Suita Hospital

    Suita, 564-0013

  • Osaka University Hospital

    Suita, 565-0871

  • Hirose Clinic

    Tokorozawa, 359-1111

  • Kotesashi Orthopedic Clinic

    Tokorozawa-shi

  • Hishita-Hiasa Neurosurgery and

    Tokushima

  • Toyo Hospital

    Tokushima

  • Kyoundo Hospital

    Tokyo, 101-0062

  • Mitsui Memorial Hospital

    Tokyo, 101-8643

  • The Jikei University Hospital

    Tokyo, 105-8461

  • Toranomon Hospital

    Tokyo, 105-8470

  • The University of Tokyo

    Tokyo, 108-8639

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Tokyo Metropolitan Bokutoh Hos

    Tokyo, 130-8575

  • Keiyo Hospital

    Tokyo, 132-0025

  • Toho Univ Med Ctr Omori Hosp

    Tokyo, 143-8541

  • Tokyo Medical University Hosp

    Tokyo, 16000-23

  • National Ctr Global Health Med

    Tokyo, 162-8655

  • Tokyo Womens Med Univ Hosp

    Tokyo, 162-8666

  • Kawakita General Hospital

    Tokyo, 166-8588

  • Nihon University Itabashi Hosp

    Tokyo, 173-0032

  • Juntendo Univ Nerima Hosp

    Tokyo, 177-0033

  • JP Red Cross Musashino Hosp

    Tokyo, 180-8610

  • Akasaka Chuo Clinic

    Tokyo

  • Edogawa Hospital

    Tokyo

  • Ishigaki Orthopedic Clinic

    Tokyo

  • Kanamecho Hospital

    Tokyo

  • Matsuda Orthopedic Rheuma Clin

    Tokyo

  • NHO Disaster Medical Center

    Tokyo

  • Showa University Hospital

    Tokyo

  • Yoshida Internal Med Clinic

    Tokyo

  • Matsuno Clinic Rheumatic Disea

    Toyama, 930-0138

  • Toyama Prefectural Ctr Hosp

    Toyama, 930-0975

  • Fujita Health University Hosp

    Toyoake, 470-1192

  • Toyama University Hospital

    Toyoma, 930-0194

  • Toyooka Hospital

    Toyooka, 668-8501

  • Kishi Orthopedics Medical Clin

    Tsuchiura-shi

  • Tsukuba University Hospital

    Tsukuba, 305-8576

  • Tsuyama Chuo Memorial Hospital

    Tsuyama, 708-0024

  • Daini Okamoto General Hospital

    Uji

  • Wakayama Medical University

    Wakayama, 641-8510

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yamagata City Hosp Saiseikai

    Yamagata

  • Yamaguchi Red Cross Hospital

    Yamaguchi, 753-8519

  • Shuto General Hospital

    Yanai-shi, 742-0032

  • Kumamoto Rosai Hospital

    Yatsushiro-shi

  • Yokohama City Univ Medical Ctr

    Yokohama, Kanagawa, 232-0024

  • Showa Univ N Yokohama Hosp

    Yokohama, 224-8503

  • Tottori University Hospital

    Yonago-shi, 683-8504

  • Teikyo University Hospital

    板橋区, Tokyo, 〒173-8605

Other trials in Japan

About this study

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

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
Keywords
Ankylosing Spondylitis
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01329380
Study groupRoleWhat they receive
AdalimumabParticipants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 weeks

  2. 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

    Measured: 24 weeks

  3. 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.

    Measured: 24 weeks

  4. Number of Participants With Self-injection Errors

    Measured: 24 weeks

Secondary outcomes (3)

  1. 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

    Measured: Weeks 12, 24, and at the last visit

  2. 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

    Measured: 24 weeks (or last visit if earlier)

  3. 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.

    Measured: Baseline and weeks 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2011 (estimated)
  2. Study start27 Oct 2010
  3. Primary completion28 Dec 2017
  4. Study completion28 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
403 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01329380
Sponsor's protocol ID
P12-764
Status last verified
Dec 2018
First submitted
17 Mar 2011
Last updated
3 Apr 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ankylosing Spondylitis, run by AbbVie at 194 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 194 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Drug Reactions (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01329380.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.

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