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Trial record 1 of 1 for:    NCT00624338
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Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE) (APRIL-SLE)

This study has been completed.
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00624338
First received: February 15, 2008
Last updated: March 11, 2016
Last verified: March 2016
Results First Received: January 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lupus Erythematosus, Systemic
Interventions: Drug: Atacicept 75 mg
Drug: Atacicept 150 mg
Other: Placebo Comparator

  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
Atacicept 75 mg 75 milligram (mg) atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Atacicept 150 mg 150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Placebo Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.

Participant Flow:   Overall Study
    Atacicept 75 mg   Atacicept 150 mg   Placebo
STARTED   159   145   157 
Treated   157   144   154 
COMPLETED   112   62   111 
NOT COMPLETED   47   83   46 
Adverse Event                14                14                18 
Lost to Follow-up                1                0                0 
Lack of Efficacy                11                3                14 
Protocol Violation                3                3                2 
Death                0                2                0 
Immunoglobulin less than 3gram per liter                1                0                0 
Termination of 150 mg group by Sponsor                0                55                0 
Unspecified                15                5                9 
Randomized but not treated                2                1                3 



  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 the randomized participants, regardless of whether they received treatment.

Reporting Groups
  Description
Atacicept 75 mg 75 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Atacicept 150 mg 150 mg atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Placebo Placebo matched to atacicept injection was administered subcutaneously twice weekly during initial loading period for 4 weeks followed by once weekly during maintenance period for subsequent 48 weeks.
Total Total of all reporting groups

Baseline Measures
   Atacicept 75 mg   Atacicept 150 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 159   145   157   461 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.1  (12.0)   39.0  (12.8)   39.0  (12.1)   39.0  (12.2) 
Gender 
[Units: Participants]
       
Female   148   134   148   430 
Male   11   11   9   31 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Experiencing a New Flare as Defined by British Isles Lupus Assessment Group (BILAG) Score A or B   [ Time Frame: From screening up to Week 52 ]

2.  Secondary:   Time to First New Flare as Defined by BILAG Score A or B   [ Time Frame: From screening up to Week 52 ]

3.  Secondary:   Percentage of Participants Experiencing a New Flare as Defined by BILAG Score A or B During Initial 24 Weeks   [ Time Frame: From screening up to Week 24 ]

4.  Secondary:   Percentage of Participants Within Ordinal Response Categories for British Isles Lupus Assessment Group (BILAG) Flares   [ Time Frame: Week 52 ]

5.  Secondary:   Mean Cumulative Corticosteroid Dose   [ Time Frame: Randomization up to Week 52 ]


  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
Atacicept 150 mg group was discontinued on 2 February 2011 based on the recommendation from the Independent Data Monitoring Committee.


  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 Healthcare, a business of Merck KGaA, Darmstadt, Germany
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00624338     History of Changes
Other Study ID Numbers: 27646
Study First Received: February 15, 2008
Results First Received: January 19, 2016
Last Updated: March 11, 2016
Health Authority: United States: Food and Drug Administration