A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT00870467 |
Recruitment Status :
Completed
First Posted : March 27, 2009
Results First Posted : April 5, 2012
Last Update Posted : August 7, 2012
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Sponsor:
Abbott
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Abbott
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Rheumatoid Arthritis |
Interventions |
Biological: Double-blind adalimumab Drug: Double-blind Placebo Biological: Open-label Adalimumab Biological: Open-labelAdalimumabRescue |
Enrollment | 334 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | DB Adalimumab | DB Placebo | DB Adalimumab/OL Adalimumab | DB Placebo/OL Adalimumab | DB Adalimumab/RE OL Adalimumab | DB Placebo/RE OL Adalimumab |
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Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. | Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. | Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. | Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. | Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. | Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. |
Period Title: Double-blind | ||||||
Started | 171 | 163 | 0 | 0 | 0 | 0 |
Completed | 155 [1] | 151 [2] | 0 | 0 | 0 | 0 |
Not Completed | 16 | 12 | 0 | 0 | 0 | 0 |
[1]
10 participants who completed 26 weeks received open-label adalimumab 40 mg eow as rescue therapy
[2]
24 participants who completed 26 weeks received open-label adalimumab 40 mg eow as rescue therapy
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Period Title: Open-label | ||||||
Started | 0 | 0 | 145 | 127 | 10 | 24 |
Completed | 0 | 0 | 132 | 120 | 5 | 21 |
Not Completed | 0 | 0 | 13 | 7 | 5 | 3 |
Baseline Characteristics
Arm/Group Title | DB Adalimumab | DB Placebo | Total | |
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Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. | Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. | Total of all reporting groups | |
Overall Number of Baseline Participants | 171 | 163 | 334 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 171 participants | 163 participants | 334 participants | |
54.0 (13.13) | 54.0 (13.20) | 54.0 (13.15) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 171 participants | 163 participants | 334 participants | |
Female |
144 84.2%
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128 78.5%
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272 81.4%
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Male |
27 15.8%
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35 21.5%
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62 18.6%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Japan | Number Analyzed | 171 participants | 163 participants | 334 participants |
171 | 163 | 334 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: | Global Medical Services |
Organization: | Abbott |
Phone: | 800-633-9110 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Abbott |
ClinicalTrials.gov Identifier: | NCT00870467 |
Other Study ID Numbers: |
M06-859 |
First Submitted: | March 26, 2009 |
First Posted: | March 27, 2009 |
Results First Submitted: | March 9, 2012 |
Results First Posted: | April 5, 2012 |
Last Update Posted: | August 7, 2012 |