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Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III) (August III)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00664521
First received: April 21, 2008
Last updated: November 4, 2016
Last verified: November 2016
Results First Received: September 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Biological: Rituximab
Drug: Atacicept
Drug: Placebo matched to atacicept

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rituximab Plus Atacicept Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
Rituximab Plus Placebo Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.

Participant Flow:   Overall Study
    Rituximab Plus Atacicept   Rituximab Plus Placebo
STARTED   18   9 
COMPLETED   12   8 
NOT COMPLETED   6   1 
Adverse Event                4                1 
Lost to Follow-up                1                0 
Unspecified                1                0 



  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.
Intent-to-treat (ITT) population included all randomized participants.

Reporting Groups
  Description
Rituximab Plus Atacicept Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
Rituximab Plus Placebo Rituximab was administered as an intravenous infusion at a dose of 1000 milligram (mg) at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
Total Total of all reporting groups

Baseline Measures
   Rituximab Plus Atacicept   Rituximab Plus Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   9   27 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.0  (11.0)   57.7  (11.5)   57.2  (11.0) 
Gender 
[Units: Participants]
Count of Participants
     
Female      12  66.7%      8  88.9%      20  74.1% 
Male      6  33.3%      1  11.1%      7  25.9% 


  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Week 64 ]

2.  Primary:   Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L)   [ Time Frame: Week 64 ]

3.  Primary:   Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32   [ Time Frame: Baseline, Week 32 ]

4.  Primary:   Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32   [ Time Frame: Baseline, Week 32 ]

5.  Primary:   Percent Change From Baseline in Anti-pneumococcus Titer at Week 32   [ Time Frame: Baseline, Week 32 ]

6.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32   [ Time Frame: Week 32 ]

7.  Secondary:   Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32   [ Time Frame: Baseline, Week 32 ]

8.  Secondary:   Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells   [ Time Frame: Baseline, Week 3, 7, 12, 16, 26 and 32 ]


  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: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


Publications of Results:

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00664521     History of Changes
Other Study ID Numbers: 28155
Study First Received: April 21, 2008
Results First Received: September 16, 2016
Last Updated: November 4, 2016