Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859(NCT00870467))
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01163292
First received: July 14, 2010
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
The present survey will be conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in the M06-859 study in patients who have continued treatment with adalimumab for 52 weeks.
| Condition |
|---|
|
Rheumatoid Arthritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Humira 40mg/0.8mL Syringe for Subcutaneous Injection -Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)) |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Adalimumab
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Evaluation of adverse event [ Time Frame: at week 52 ] [ 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 week 26 ] [ Designated as safety issue: No ]
- Improvement rating on the basis of Disease Activity Score28 [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
- Matrix metalloprotease-3 [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
- Matrix metalloprotease-3 [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
- X-ray findings for hands and feet [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
- Health Assessment Questionnaire [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
- Health Assessment Questionnaire [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
| Enrollment: | 220 |
| Study Start Date: | March 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Humira
Those with an exposure
|
|
Control (Non-Humira)
Patients who discontinue adalimumab treatment after completion of the M06-859 study
|
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
The participants will be patients who have continued treatment with adalimumab until the end of the treatment period in the M06-859 study.
Criteria
Inclusion Criteria:
- The participants will be patients who have continued treatment with adalimumab until the end of the treatment period in the M06-859 study.
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).
- Patients who use biological agents other than adalimumab after the period of treatment in the M06-859 study will be excluded from the present follow-up study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163292
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Hide Study LocationsLocations
| Japan | |
| Site Reference ID/Investigator# 54680 | |
| Anjo, Japan | |
| Site Reference ID/Investigator# 54677 | |
| Aomori, Japan | |
| Site Reference ID/Investigator# 54516 | |
| Chiba, Japan | |
| Site Reference ID/Investigator# 54660 | |
| Chiba, Japan | |
| Site Reference ID/Investigator# 54683 | |
| Chiba, Japan | |
| Site Reference ID/Investigator# 54659 | |
| Chiba, Japan | |
| Site Reference ID/Investigator# 39852 | |
| Fuchu, Japan | |
| Site Reference ID/Investigator# 54521 | |
| Fukuoka, Japan | |
| Site Reference ID/Investigator# 39854 | |
| Gifu, Japan | |
| Site Reference ID/Investigator# 54682 | |
| Hiroshima, Japan | |
| Site Reference ID/Investigator# 54669 | |
| Hyogo, Japan | |
| Site Reference ID/Investigator# 54674 | |
| Hyogo, Japan | |
| Site Reference ID/Investigator# 54653 | |
| Ibaraki, Japan | |
| Site Reference ID/Investigator# 54692 | |
| Kagoshima, Japan | |
| Site Reference ID/Investigator# 54670 | |
| Kagoshima, Japan | |
| Site Reference ID/Investigator# 39843 | |
| Kanagawa, Japan | |
| Site Reference ID/Investigator# 54665 | |
| Kanagawa, Japan | |
| Site Reference ID/Investigator# 54661 | |
| Kanagawa, Japan | |
| Site Reference ID/Investigator# 59580 | |
| Kawagoe, Japan | |
| Site Reference ID/Investigator# 54662 | |
| Kawasaki, Japan | |
| Site Reference ID/Investigator# 54693 | |
| Kirishima, Japan | |
| Site Reference ID/Investigator# 54671 | |
| Kitakyushu, Japan | |
| Site Reference ID/Investigator# 54643 | |
| Kumamoto, Japan | |
| Site Reference ID/Investigator# 59583 | |
| Kyoto, Japan | |
| Site Reference ID/Investigator# 59582 | |
| Maebashi, Japan | |
| Site Reference ID/Investigator# 54520 | |
| Matsuyama, Japan | |
| Site Reference ID/Investigator# 54644 | |
| Miyazaki, Japan | |
| Site Reference ID/Investigator# 54645 | |
| Morioka, Japan | |
| Site Reference ID/Investigator# 39849 | |
| Nagano, Japan | |
| Site Reference ID/Investigator# 54654 | |
| Nagano, Japan | |
| Site Reference ID/Investigator# 63052 | |
| Nagasaki, Japan | |
| Site Reference ID/Investigator# 54667 | |
| Nagoya, Japan | |
| Site Reference ID/Investigator# 54673 | |
| Nagoya, Japan | |
| Site Reference ID/Investigator# 54649 | |
| Nara, Japan | |
| Site Reference ID/Investigator# 39844 | |
| Niigata, Japan | |
| Site Reference ID/Investigator# 54656 | |
| Niigata, Japan | |
| Site Reference ID/Investigator# 54675 | |
| Oita, Japan | |
| Site Reference ID/Investigator# 39847 | |
| Okayama, Japan | |
| Site Reference ID/Investigator# 54681 | |
| Okayama, Japan | |
| Site Reference ID/Investigator# 54650 | |
| Okayama, Japan | |
| Site Reference ID/Investigator# 39846 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 54518 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 54646 | |
| Rifu, Japan | |
| Site Reference ID/Investigator# 54679 | |
| Saitama, Japan | |
| Site Reference ID/Investigator# 54689 | |
| Saitama, Japan | |
| Site Reference ID/Investigator# 54514 | |
| Saitama, Japan | |
| Site Reference ID/Investigator# 54515 | |
| Saitama, Japan | |
| Site Reference ID/Investigator# 54652 | |
| Sapporo, Japan | |
| Site Reference ID/Investigator# 54651 | |
| Sapporo, Japan | |
| Site Reference ID/Investigator# 25922 | |
| Sapporo, Japan | |
| Site Reference ID/Investigator# 39850 | |
| Sapporo, Japan | |
| Site Reference ID/Investigator# 54522 | |
| Sasebo, Japan | |
| Site Reference ID/Investigator# 39851 | |
| Shimotsuke, Japan | |
| Site Reference ID/Investigator# 54517 | |
| Shizuoka, Japan | |
| Site Reference ID/Investigator# 39845 | |
| Shizuoka, Japan | |
| Site Reference ID/Investigator# 54666 | |
| Shizuoka, Japan | |
| Site Reference ID/Investigator# 59579 | |
| Takamatsu, Japan | |
| Site Reference ID/Investigator# 54655 | |
| Takasaki, Japan | |
| Site Reference ID/Investigator# 54519 | |
| Tenri, Japan | |
| Site Reference ID/Investigator# 54658 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 54647 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 54657 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 59581 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 39853 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 39842 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 54678 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 54688 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 54672 | |
| Tomigusuku, Japan | |
| Site Reference ID/Investigator# 54691 | |
| Toyama, Japan | |
| Site Reference ID/Investigator# 54648 | |
| Toyama, Japan | |
| Site Reference ID/Investigator# 54690 | |
| Toyoake, Japan | |
| Site Reference ID/Investigator# 54676 | |
| Toyohashi, Japan | |
| Site Reference ID/Investigator# 54668 | |
| Tsu, Japan | |
| Site Reference ID/Investigator# 54664 | |
| Yokohama, Japan | |
| Site Reference ID/Investigator# 54663 | |
| 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: | NCT01163292 History of Changes |
| Other Study ID Numbers: | P12-069 |
| Study First Received: | July 14, 2010 |
| Last Updated: | January 2, 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 Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013