Special Investigation of Humira on Long-term Treatment in Patients With Rheumatoid Arthritis
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01163318
First received: July 14, 2010
Last updated: April 22, 2013
Last verified: April 2013
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Purpose
The present survey will be conducted to collect information on the safety (especially the development of malignant tumors, infections, and other untoward events) and effectiveness of Humira 40 mg/0.8 mL Syringe for Subcutaneous Injection (Humira) in patients receiving the drug for a long period of time for the treatment of rheumatoid arthritis, for the purpose of investigating and confirming factors affecting the safety and effectiveness of the drug.
| Condition |
|---|
|
Rheumatoid Arthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Special Investigation on Long-term Treatment in Patients With Rheumatoid Arthritis |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Evaluation of adverse event [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]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
- Evaluation of adverse event [ Time Frame: at 1.5 years ] [ Designated as safety issue: Yes ]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
- Evaluation of adverse event [ Time Frame: at 2 years ] [ Designated as safety issue: Yes ]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
- Evaluation of adverse event [ Time Frame: at 2.5 years ] [ Designated as safety issue: Yes ]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
- Evaluation of adverse event [ Time Frame: at 3 years ] [ Designated as safety issue: Yes ]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
- Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
- Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 1.5 years ] [ Designated as safety issue: No ]
- Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
- Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 2.5 years ] [ Designated as safety issue: No ]
- Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
- Modified Health Assessment Questionnaire [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
- Modified Health Assessment Questionnaire [ Time Frame: at 1.5 years ] [ Designated as safety issue: No ]
- Modified Health Assessment Questionnaire [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
- Modified Health Assessment Questionnaire [ Time Frame: at 2.5 years ] [ Designated as safety issue: No ]
- Modified Health Assessment Questionnaire [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Humira
Those with an exposure
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Those who are receiving Humira in accordance with its indications for treatment and dosage regimens
Criteria
Inclusion Criteria:
- Those who are receiving Humira in accordance with its indications for treatment and dosage regimens
- Those who are using Humira continuously
- Those with no current and no past history of malignant tumor
- Those evaluable for Disease Activity Score28-4erythrocyte sedimentation rate
- Patients who have been evaluated by Health Assessment Questionnaire or Modified Health Assessment Questionnaire prior to initiation of Humira treatment (prior to initial administration of Humira in the all-case 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 cardiac failure congestive
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163318
Hide Study Locations
Hide Study LocationsLocations
| Japan | |
| Site Reference ID/Investigator# 54504 | |
| Aichi, Japan | |
| Site Reference ID/Investigator# 40028 | |
| Aichi, Japan | |
| Site Reference ID/Investigator# 40054 | |
| Akita, Japan | |
| Site Reference ID/Investigator# 39993 | |
| Aomori, Japan | |
| Site Reference ID/Investigator# 40009 | |
| Aomori, Japan | |
| Site Reference ID/Investigator# 40062 | |
| Aomori, Japan | |
| Site Reference ID/Investigator# 40504 | |
| Asahikawa, Japan | |
| Site Reference ID/Investigator# 54513 | |
| Chiba, Japan | |
| Site Reference ID/Investigator# 54512 | |
| Chiba, Japan | |
| Site Reference ID/Investigator# 40091 | |
| Chikushi, Japan | |
| Site Reference ID/Investigator# 40076 | |
| Fukui, Japan | |
| Site Reference ID/Investigator# 40098 | |
| Fukuoka, Japan | |
| Site Reference ID/Investigator# 39999 | |
| Fukuoka, Japan | |
| Site Reference ID/Investigator# 39994 | |
| Fukuoka, Japan | |
| Site Reference ID/Investigator# 40096 | |
| Fukuoka, Japan | |
| Site Reference ID/Investigator# 40007 | |
| Fukushima, Japan | |
| Site Reference ID/Investigator# 40004 | |
| Fukushima, Japan | |
| Site Reference ID/Investigator# 39992 | |
| Fukushima, Japan | |
| Site Reference ID/Investigator# 40026 | |
| Gifu, Japan | |
| Site Reference ID/Investigator# 40022 | |
| Gifu, Japan | |
| Site Reference ID/Investigator# 40050 | |
| Gunma, Japan | |
| Site Reference ID/Investigator# 40012 | |
| Gyoda, Japan | |
| Site Reference ID/Investigator# 40025 | |
| Hamamatsu, Japan | |
| Site Reference ID/Investigator# 40030 | |
| Hamamatsu, Japan | |
| Site Reference ID/Investigator# 54508 | |
| Hirakata, Japan | |
| Site Reference ID/Investigator# 54509 | |
| Hirakata, Japan | |
| Site Reference ID/Investigator# 40085 | |
| Hiroshima, Japan | |
| Site Reference ID/Investigator# 39989 | |
| Hokkaido, Japan | |
| Site Reference ID/Investigator# 39991 | |
| Hyogo, Japan | |
| Site Reference ID/Investigator# 40075 | |
| Hyogo, Japan | |
| Site Reference ID/Investigator# 40057 | |
| Hyogo, Japan | |
| Site Reference ID/Investigator# 40089 | |
| Isahaya, Japan | |
| Site Reference ID/Investigator# 54505 | |
| Ishikawa, Japan | |
| Site Reference ID/Investigator# 40072 | |
| Ishikawa, Japan | |
| Site Reference ID/Investigator# 40048 | |
| Ishikawa, Japan | |
| Site Reference ID/Investigator# 40503 | |
| Ishikawa, Japan | |
| Site Reference ID/Investigator# 40029 | |
| Izunokuni, Japan | |
| Site Reference ID/Investigator# 40052 | |
| Jonan-ku, Fukuoka-shi, Japan | |
| Site Reference ID/Investigator# 54506 | |
| Kagawa, Japan | |
| Site Reference ID/Investigator# 40090 | |
| Kagoshima, Japan | |
| Site Reference ID/Investigator# 25923 | |
| Kanagawa, Japan | |
| Site Reference ID/Investigator# 40046 | |
| Kawagoe, Japan | |
| Site Reference ID/Investigator# 39983 | |
| Kawasaki, Japan | |
| Site Reference ID/Investigator# 40097 | |
| Kirishima, Japan | |
| Site Reference ID/Investigator# 40094 | |
| Kitakyushu, Japan | |
| Site Reference ID/Investigator# 39984 | |
| Kobe, Japan | |
| Site Reference ID/Investigator# 54507 | |
| Kochi, Japan | |
| Site Reference ID/Investigator# 40045 | |
| Koshigaya, Japan | |
| Site Reference ID/Investigator# 40082 | |
| Kyoto, Japan | |
| Site Reference ID/Investigator# 39988 | |
| Matsumoto, Japan | |
| Site Reference ID/Investigator# 40027 | |
| Mie, Japan | |
| Site Reference ID/Investigator# 39997 | |
| Miyazaki, Japan | |
| Site Reference ID/Investigator# 40099 | |
| Nagasaki, Japan | |
| Site Reference ID/Investigator# 40093 | |
| Nagasaki, Japan | |
| Site Reference ID/Investigator# 40060 | |
| Nagoya, Japan | |
| Site Reference ID/Investigator# 40021 | |
| Nagoya, Japan | |
| Site Reference ID/Investigator# 40023 | |
| Nagoya, Japan | |
| Site Reference ID/Investigator# 40024 | |
| Nagoya, Japan | |
| Site Reference ID/Investigator# 40078 | |
| Nara, Japan | |
| Site Reference ID/Investigator# 40077 | |
| Nara, Japan | |
| Site Reference ID/Investigator# 39987 | |
| Narashino, Japan | |
| Site Reference ID/Investigator# 40051 | |
| Niigata, Japan | |
| Site Reference ID/Investigator# 40049 | |
| Niigata, Japan | |
| Site Reference ID/Investigator# 40066 | |
| Obihiro, Japan | |
| Site Reference ID/Investigator# 39982 | |
| Okayama, Japan | |
| Site Reference ID/Investigator# 39990 | |
| Okayama, Japan | |
| Site Reference ID/Investigator# 40095 | |
| Okinawa, Japan | |
| Site Reference ID/Investigator# 40056 | |
| Omaezaki, Japan | |
| Site Reference ID/Investigator# 40092 | |
| Omuta, Japan | |
| Site Reference ID/Investigator# 39996 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 39995 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 40080 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 40079 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 40073 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 40043 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 40001 | |
| Osakasayama, Japan | |
| Site Reference ID/Investigator# 40063 | |
| Osaki, Japan | |
| Site Reference ID/Investigator# 40069 | |
| Osaki, Japan | |
| Site Reference ID/Investigator# 40081 | |
| Otsu, Japan | |
| Site Reference ID/Investigator# 40068 | |
| Sagamihara, Japan | |
| Site Reference ID/Investigator# 40016 | |
| Sagamihara, Kanagawa, Japan | |
| Site Reference ID/Investigator# 40014 | |
| Saitama, Japan | |
| Site Reference ID/Investigator# 40013 | |
| Saitama, Japan | |
| Site Reference ID/Investigator# 40015 | |
| Sakado, Japan | |
| Site Reference ID/Investigator# 39998 | |
| Sakai, Japan | |
| Site Reference ID/Investigator# 40055 | |
| Sapporo, Japan | |
| Site Reference ID/Investigator# 40065 | |
| Sapporo, Japan | |
| Site Reference ID/Investigator# 40058 | |
| Sapporo, Japan | |
| Site Reference ID/Investigator# 40064 | |
| Sapporo, Japan | |
| Site Reference ID/Investigator# 39986 | |
| Sasebo, Japan | |
| Site Reference ID/Investigator# 40061 | |
| Sendai, Japan | |
| Site Reference ID/Investigator# 40053 | |
| Sendai, Japan | |
| Site Reference ID/Investigator# 40086 | |
| Shimane, Japan | |
| Site Reference ID/Investigator# 40003 | |
| Shimotsuke, Japan | |
| Site Reference ID/Investigator# 54510 | |
| Shizuoka, Japan | |
| Site Reference ID/Investigator# 40000 | |
| Takamatsu, Japan | |
| Site Reference ID/Investigator# 40074 | |
| Takatsuki, Japan | |
| Site Reference ID/Investigator# 40084 | |
| Tohaku, Japan | |
| Site Reference ID/Investigator# 40502 | |
| Tokushima, Japan | |
| Site Reference ID/Investigator# 40047 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40067 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40042 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40020 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40019 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40018 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40017 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40010 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40059 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40044 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40011 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40506 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40008 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40006 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40005 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 54511 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 40088 | |
| Tottori, Japan | |
| Site Reference ID/Investigator# 39985 | |
| Toyama, Japan | |
| Site Reference ID/Investigator# 40087 | |
| Toyama, Japan | |
| Site Reference ID/Investigator# 40083 | |
| Toyama, Japan | |
| Site Reference ID/Investigator# 40002 | |
| Toyohashi, Japan | |
| Site Reference ID/Investigator# 40507 | |
| Utazu, Japan | |
| Site Reference ID/Investigator# 40505 | |
| Yokohama, Japan | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Toshiro Maeda | AbbVie GK |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01163318 History of Changes |
| Other Study ID Numbers: | P12-070 |
| Study First Received: | July 14, 2010 |
| Last Updated: | April 22, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by AbbVie:
|
Rheumatoid Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013