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Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01412021
Recruitment Status : Active, not recruiting
First Posted : August 8, 2011
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:

This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints 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

Condition or disease
Arthritis, Juvenile Rheumatoid

Study Type : Observational
Actual Enrollment : 375 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis
Actual Study Start Date : August 1, 2011
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Humira
those with an exposure



Primary Outcome Measures :
  1. Serum Matrix metalloprotease-3 level [ Time Frame: at week 12 ]
  2. Weight [ Time Frame: at week 4 ]
  3. Anti-cyclic citrullinated peptides antibodies [ Time Frame: at baseline ]
  4. Serum Matrix metalloprotease-3 level [ Time Frame: at week 8 ]
  5. Height [ Time Frame: at week 16 ]
  6. Disease Activity Score28 [ Time Frame: at week 12 ]
  7. Weight [ Time Frame: at week 16 ]
  8. Anti-cyclic citrullinated peptides antibodies [ Time Frame: at week 24 ]
  9. Global health by physicians (Visual Analog Scale) [ Time Frame: at week 4 ]
  10. Global health by physicians (Visual Analog Scale) [ Time Frame: at week 24 ]
  11. Height [ Time Frame: at week 24 ]
  12. Disease Activity Score28 [ Time Frame: at week 16 ]
  13. Height [ Time Frame: at week 12 ]
  14. Global health by physicians (Visual Analog Scale) [ Time Frame: at week 16 ]
  15. Number of patients with adverse drug reactions [ Time Frame: at week 24 ]
    Occurrence of adverse event (yes or no), nature of adverse drug reactions, date of onset, seriousness, clinical course of adverse drug reactions, outcome, measures, causal relationship between the adverse drug reactions and Humira

  16. Disease Activity Score28 [ Time Frame: at week 8 ]
  17. Serum Matrix metalloprotease-3 level [ Time Frame: at week 4 ]
  18. Serum Matrix metalloprotease-3 level [ Time Frame: at week 16 ]
  19. Weight [ Time Frame: at week 8 ]
  20. Weight [ Time Frame: at week 12 ]
  21. Global health by physicians (Visual Analog Scale) [ Time Frame: at week 8 ]
  22. Disease Activity Score28 [ Time Frame: at week 4 ]
  23. Disease Activity Score28 [ Time Frame: at week 24 ]
  24. Serum Matrix metalloprotease-3 level [ Time Frame: at week 24 ]
  25. Height [ Time Frame: at week 4 ]
  26. Height [ Time Frame: at week 8 ]
  27. Weight [ Time Frame: at week 24 ]
  28. Global health by physicians (Visual Analog Scale) [ Time Frame: at week 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who receive Humira for the treatment of Juvenile idiopathic arthritis
Criteria

Inclusion Criteria:

  • All patients with Juvenile idiopathic arthritis 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412021


  Hide Study Locations
Locations
Japan
Kurume University Hospital
久留米市, Fukuoka, Japan, 〒830-0011
Gunma University Hospital
Maebashi-shi, Gunma, Japan, 371-8511
Kitasato University Hospital
Sagamihara-shi, Kanagawa, Japan, 252-0375
Yokohama City Univ Medical Ctr
Yokohama, Kanagawa, Japan, 232-0024
Miyagi Children's Hospital
Sendai-shi, Miyagi, Japan, 989-3126
Nagasaki University Hospital
長崎市, Nagasaki, Japan, 〒852-8102
Okayama University Hospital
Okayama-shi, Okayama, Japan, 700-0914
Kindai University Hospital
Osaka Sayama-shi, Osaka, Japan, 589-8511
Osaka Medical College Hospital
Takatsuki, Osaka, Japan, 569-0801
Osaka City University Hospital
大阪市, Osaka, Japan, 〒545-0051
NHO Osaka Minami Med Ctr
河内長野市, Osaka, Japan, 〒586-8521
Saitama Medical Center
Kawagoe, Saitama, Japan, 350-8550
Saitama Children's Medical Center
Saitama-shi, Saitama, Japan, 330-8777
Dokkyo Medical University Saitama Medical Center
越谷市, Saitama, Japan, 〒343-0813
Hamamatsu University Hospital
Higashi-ku, Shizuoka, Japan, 431-3192
Jichi Medical University Hospi
Shimotsuke-shi, Tochigi, Japan, 329-0498
Medical Hospital of Tokyo Medical and Dental University
Bunkyo-ku, Tokyo, Japan, 113-8519
St.Luke's International Hospital
中央区, Tokyo, Japan, 〒104-8560
Akita City Hospital
Akita, Japan, 010-0933
Anan Kyoei Hospital
Anan, Japan, 779-1198
NHO Aomori National Hospital
Aomori, Japan
Katayama Orthopedic Rheum Clin
Asahikawa, Japan, 078-8243
Chiba Children's Hospital
Chiba-shi, Japan
Chiba University Hospital
Chiba, Japan, 260-8677
New-Ooe Hospital
Fukuchiyama, Japan
Fukui Prefectural Hospital
Fukui, Japan, 910-0846
Kirigaoka Tsuda Hospital
Fukuoka, Japan, 802-0052
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Showa Hospital
Fukuoka, Japan
Fukushima Med Univ Hosp
Fukushima-shi, Japan, 960-1295
Hachinohe Red Cross Hospital
Hachinohe-shi, Japan
Hakodate Central General Hosp
Hakodate-shi, Japan
Seirei Hamamatsu General Hosp
Hamamatsu, Japan, 430-8558
Hamamatsu Medical Center
Hamamatsu, Japan, 432-8002
Seirei Mikatahara General Hosp
Hamamatsu, Japan
Japanese Red Cross Society Him
Himeji, Japan, 670-8540
Hiroshima Clinic
Hiroshima-shi, Japan
Nojima Internal Medicine
Hiroshima-shi, Japan
Hiroshima Prefecture Hospital
Hiroshima, Japan, 734-0004
Hiroshima University Hospital
Hiroshima, Japan, 734-0037
Yamaguchi Grand Medical Center
Hofu, Japan
Ina Central Hospital
INA, Japan, 396-0033
Nippon Med Chiba Hokusoh Hosp
Inzai, Japan, 270-1613
Ise Red Cross Hospital
ISE, Japan, 516-0008
Shimane Prefectural Central Ho
Izumo-shi, Japan
Shimane University Hospital
Izumo, Japan, 693-0021
Kagoshima Univ Medical and Den
Kagoshima-shi, Japan
Kagoshima Red Cross Hospital
Kagoshima, Japan
Kanazawa University Ho
Kanazawa, Japan, 920-8641
Nara Medical Univ Hospital
Kashihara, Japan, 634-0813
The Jikei Univ. Kashiwa Hosp.
Kashiwa, Japan, 277-0004
Matsubara Mayflower Hospital
Kato, Japan, 673-1462
Kitakami Saiseikai Hospital
Kitakami, Japan, 024-8506
Univ Occup & Environ Health
Kitakyushu, Japan, 807-8556
NHO Kokura Medical Center
Kitakyusyu-shi, Japan
Kobe City Med Ctr General Hosp
Kobe-shi, Japan, 650-0046
Kobe University Hospital
Kobe, Japan, 650-0017
Hyogo Pref Childrens Kobe Hosp
Kobe, Japan, 654-0081
Ogihara Misaki Hospital
Kobe, Japan
Daiichi Hospital
Kochi-shi, Japan
Komatsu Municipal Hospital
Komatsu, Japan, 923-8560
Konan Kosei Hospital
Konan-shi, Japan, 483-8704
Iwate Prefectural Kuji Hospita
Kuji-shi, Japan
Kumamoto University Hospital
Kumamoto, Japan, 860-0862
Kawasaki Medical School Hosp
Kurashiki, Japan, 701-0114
Kurashiki Medical Center
Kurashiki, Japan, 710-8522
Kyoto Prefect Univ Med
Kyoto, Japan, 602-8566
Kagawa University Hospital
Kyoto, Japan, 615-8256
Matsue Red Cross Hospital
Matsue, Japan, 690-8506
Shinshu University Hospital
Matsumoto-shi, Japan, 390-8621
Matsuyama Red Cross Hosp
Matsuyama, Japan, 790-0826
Mito Saiseikai General Hosp
Mito, Japan, 311-4198
Iwate Medical University Hosp
Morioka, Japan, 020-0023
Shiga Medical Center for Child
Moriyama-shi, Japan
Aichi Medical University Hosp
Nagakute, Japan, 480-1195
Saiseikai Kyoto Hospital
Nagaokakyo, Japan
Nagoya City West Medical Ctr
Nagoya, Japan, 462-8508
Jurakukai Ohno Memorial Hosp
Naniwa, Japan, 550-0015
Kochi Medical School Hospital
Nankoku-shi, Japan, 783-8505
Nayoro City General Hospital
Nayoro, Japan, 096-8511
Niigata Univ Med Dental Hosp
Niigata, Japan, 951-8520
Iwate Prefectural Ninohe Hosp
Ninohe-shi, Japan
Miyazaki Prefectural Nobeoka H
Nobeoka, Japan, 882-0835
Obihiro-Kosei General Hospital
Obihiro, Japan, 080-0016
Aichi Children's Health & Med.
Obu-shi, Japan, 474-8710
Tokai University Oiso Hospital
Oiso-machi, Japan
Oita Prefectural Hospital
Oita, Japan, 870-0855
University of the Ryukyus Hosp
Okinawa, Japan, 903-0215
Nanbu Hospital
Okinawa, Japan
NHO Nagasaki Medical Ctr
Omura-shi, Japan, 856-8562
Osaka City General Hospital
Osaka, Japan, 534-0021
Osaka Red Cross Hospital
Osaka, Japan, 543-8555
Ota Memorial Hospital
OTA, Japan, 373-8585
Saga University Hospital
Saga, Japan, 849-0937
Suzuki Kid's Clinic
Sakurai, Japan
Kyoto University Hospital
Sakyo-ku, Japan, 606-8507
Teine Keijinkai Clinic
Sapporo, Japan, 006-0811
Sapporo Medical Center NTT EC
Sapporo, Japan, 060-0061
Sapporo Medical Univ Hosp
Sapporo, Japan, 060-8543
Sapporo City General Hospital
Sapporo, Japan, 060-8604
Hokkaido University Hospital
Sapporo, Japan, 060-8648
Sapporo Yamanoue Hospital
Sapporo, Japan, 063-0006
Sasebo City General Hospital
Sasebo-shi, Japan
Izumi Himawari Clinic
Sendai-shi, Japan, 981-3135
Murata Kids' Clinic
Settu, Japan
Gunma Children's Medical Ctr
Shibukawa-shi, Japan
Shizuoka Children's Hospital
Shizuoka-shi, Japan, 420-8660
Shizuoka Kosei Hospital
Shizuoka, Japan, 420-8623
Tokuyama Central Hospital
Shunan-shi, Japan, 745-8522
Osaka University Hospital
Suita, Japan, 565-0871
Suzuka General Hospital
Suzuka, Japan
Nippon Med School Tama Nagayam
Tama-shi, Japan, 206-0025
Tenri Hospital
Tenri, Japan, 632-8552
Med Corp Kojyokai Hirose Clini
Tokorozawa-shi, Japan, 359-1111
Tokushima University Hospital
Tokushima, Japan, 770-8503
Nippon Medical School Hospital
Tokyo, Japan, 113-8602
Natl Ctr Child Health Develop
Tokyo, Japan, 157-8535
Tokyo Medical University Hosp
Tokyo, Japan, 160-0023
Tokyo Womens Med Univ Hosp
Tokyo, Japan, 162-8666
Nihon University Itabashi Hosp
Tokyo, Japan, 173-0032
JP Red Cross Musashino Hosp
Tokyo, Japan, 180-8610
Fujikawa Clinic
Tokyo, Japan
Nihon Univ Nerima Hikarigaoka
Tokyo, Japan
Showa University Hospital
Tokyo, Japan
Takinogawa Hospital
Tokyo, Japan
Ehime University Hospital
Toon, Japan, 791-0204
Takasu Rhumatic Orthpedic Clin
Tottori, Japan, 680-0874
Saiseikai Toyama Hospital
Toyama-shi, Japan
Toyama City Hospital
Toyama, Japan
Fujita Health University Hosp
Toyoake, Japan, 470-1192
Toyooka Hospital
Toyooka, Japan, 668-8501
National Mie Hospital
Tsu-shi, Japan
Tsukuba University Hospital
Tsukuba, Japan, 305-8576
Kanazawa Medical University Ho
Uchinada-machi, Japan, 920-0293
Wakayama Medical University
Wakayama, Japan, 641-8510
JP Red Cross Wakayama Med Ctr
Wakayama, Japan
Yao Municipal Hospital
YAO, Japan
Kanagawa Children's Med Ctr
Yokohama-shi, Japan, 232-8555
Yokohama Municipal Citizen's H
Yokohama, Japan, 236-0004
Yokohama Seibu Hospital
Yokohama, Japan
Tottori University Hospital
Yonago-shi, Japan, 683-8504
Oita University Hospital
Yufu-shi, Japan, 879-5503
Kagawa National Children's Hos
Zentsuji, Japan
Kansai Med University Hospital
枚方市, Japan, 〒573-1191
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01412021     History of Changes
Other Study ID Numbers: P12-769
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Arthritis, Juvenile Rheumatoid

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases