Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
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ClinicalTrials.gov Identifier: NCT00850343 |
Recruitment Status
:
Completed
First Posted
: February 25, 2009
Results First Posted
: September 17, 2014
Last Update Posted
: November 3, 2014
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Tracking Information | |||
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First Submitted Date ICMJE | February 23, 2009 | ||
First Posted Date ICMJE | February 25, 2009 | ||
Results First Submitted Date | September 9, 2014 | ||
Results First Posted Date | September 17, 2014 | ||
Last Update Posted Date | November 3, 2014 | ||
Study Start Date ICMJE | March 2009 | ||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Number of Participants With Adverse Events [ Time Frame: From the first dosing of this study up to 12 weeks (84 days) after the last dosing. The dosing was allowed until launch of certolizumab pegol for RA in Japan. The maximum duration on study drug was 204 weeks. ] An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which did not necessarily have a causal relationship with the treatment. In this study, events that occurred between the time of informed consent and the start of study medication were included in the adverse events for Study 275-08-003. Any event existing prior to the initiation of study treatment that was aggravated after initiation of study treatment was handled as a new event. The investigator assessed the severity of each AE as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A serious adverse event is an AE that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. |
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Original Primary Outcome Measures ICMJE |
Adverse events [ Time Frame: At any time ] | ||
Change History | Complete list of historical versions of study NCT00850343 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients | ||
Official Title ICMJE | A Multicenter, Open-label, Long-term Safety Study of CDP870 to Evaluate the Safety and Efficacy of CDP870 Administered Without Coadministration of Methotrexate (MTX) Over the Long Term in Patients With Active Rheumatoid Arthritis Transferred From the Efficacy Confirmatory Study (Study 275-08-003) | ||
Brief Summary | The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol when administered without coadministration of methotrexate over the long term in Japanese RA patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003. | ||
Detailed Description | This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012. | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Rheumatoid Arthritis | ||
Intervention ICMJE | Drug: Certolizumab pegol
Subcutaneous (SC) injection
Other Names:
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
208 | ||
Original Estimated Enrollment ICMJE |
130 | ||
Actual Study Completion Date | May 2013 | ||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years to 74 Years (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Japan | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00850343 | ||
Other Study ID Numbers ICMJE | CDP870-275-08-004 JapicCTI-090701 |
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Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Astellas Pharma Inc | ||
Study Sponsor ICMJE | Astellas Pharma Inc | ||
Collaborators ICMJE | UCB Japan Co. Ltd. | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Astellas Pharma Inc | ||
Verification Date | October 2014 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |