Long-term Treatment Study of Certolizumab Pegol (CDP870) as Add-on Medication to Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

This study has been completed.
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00851318
First received: February 23, 2009
Last updated: September 25, 2014
Last verified: September 2014
Results First Received: September 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Certolizumab pegol
Drug: Methotrexate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with rheumatoid arthritis (RA) who participated in Study 275-08-001 (NCT00791999) were eligible for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were assigned to treatment groups based on whether they discontinued study 275-08-001 at Week 16 or completed Week 24 and based on American College of Rheumatology 20% (ACR20) response at Week 24.

Reporting Groups
  Description
Group I Participants who were ACR20 non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Group II Participants who were ACR20 non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Group III Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Group IV Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.

Participant Flow:   Overall Study
    Group I     Group II     Group III     Group IV  
STARTED     81     19     93     92  
Completed Week 24     69     17     90     87  
Completed Week 52     64     16     87     85  
COMPLETED     51     14     72     73  
NOT COMPLETED     30     5     21     19  
Withdrawal by Subject                 7                 1                 5                 3  
Adverse Event                 13                 2                 9                 12  
Pregnancy                 0                 0                 1                 1  
Lack of Efficacy                 8                 2                 4                 2  
Non-compliance with Study Procedures                 2                 0                 1                 0  
Physician Decision                 0                 0                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Group I:Discontinued Non-responders: 200mg Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Group II:Completed Non-responders: 200mg Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Group III:Completed Responders: 200mg Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Group-IV:Completed Responders: 400mg Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
Total Total of all reporting groups

Baseline Measures
    Group I:Discontinued Non-responders: 200mg     Group II:Completed Non-responders: 200mg     Group III:Completed Responders: 200mg     Group-IV:Completed Responders: 400mg     Total  
Number of Participants  
[units: participants]
  81     19     93     92     285  
Age  
[units: years]
Mean ± Standard Deviation
  51.8  ± 10.7     51.3  ± 13.7     52.9  ± 11.0     54.1  ± 11.0     52.8  ± 11.1  
Age, Customized  
[units: participants]
         
< 65 years     72     16     81     76     245  
≧ 65 years     9     3     12     16     40  
Gender  
[units: participants]
         
Female     67     16     76     77     236  
Male     14     3     17     15     49  
Region of Enrollment  
[units: participants]
         
Japan     81     19     93     92     285  
Study-Specific Measure  
[units: kg]
Mean ± Standard Deviation
  56.30  ± 12.00     54.27  ± 9.57     55.81  ± 11.34     54.92  ± 9.47     55.56  ± 10.83  



  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   Percentage of Participants With American College of Rheumatology 20% (ACR20) Response   [ Time Frame: Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks) ]

3.  Secondary:   Percentage of Participants With American College of Rheumatology 50% (ACR50) Response   [ Time Frame: Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks) ]

4.  Secondary:   Percentage of Participants With American College of Rheumatology 70% (ACR70) Response   [ Time Frame: Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks) ]

5.  Secondary:   Change From Baseline in Disease Activity Score (DAS) 28   [ Time Frame: Baseline (of Study 275-08-001), Week 24, Week 52 and at the final assessment (maximum was 208 weeks) ]

6.  Secondary:   Change From Baseline in Modified Total Sharp Score (mTSS)   [ Time Frame: Baseline (of Study 275-08-001), Week 0 (of this study) and Week 100 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director, Global Medical Sciences
Organization: Astellas Pharma Inc.
e-mail: ClinicalTrials.Disclosure@astellas.com


No publications provided


Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00851318     History of Changes
Other Study ID Numbers: CDP870-275-08-002, JapicCTI-090700
Study First Received: February 23, 2009
Results First Received: September 9, 2014
Last Updated: September 25, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare