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Trial record 44 of 136 for:    "idiopathic inflammatory myopathy"

A Study to Evaluate the Long-Term Safety of MEDI-545 in Adult Participants With Systemic Lupus Erythematosus or Myositis

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ClinicalTrials.gov Identifier: NCT00979654
Recruitment Status : Completed
First Posted : September 18, 2009
Results First Posted : August 23, 2016
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
MedImmune LLC

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Systemic Lupus Erythematosus
Intervention: Drug: Sifalimumab

  Participant Flow

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
A total of 118 participants were Screened out of which 15 participants did not meet eligibility criteria and were considered screen failures, and 103 participants were entered into the study.

Reporting Groups
  Description
MEDI-545 All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.

Participant Flow:   Overall Study
    MEDI-545
STARTED   103 
COMPLETED   67 
NOT COMPLETED   36 
Lost to Follow-up                1 
Withdrawal by Subject                22 
Death                1 
Lack of Efficacy                6 
Adverse Event                1 
Adverse Event of Diverticulitis                1 
Per Principal Investigator’s Discretion                1 
Patient Wanted to Pursue Other Treatment                1 
Serious Adverse Event                1 
Unfavorable Risk-Benefit Analysis                1 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
MEDI-545 All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.

Baseline Measures
   MEDI-545 
Overall Participants Analyzed 
[Units: Participants]
 103 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.2  (9.9) 
Age, Customized 
[Units: Participants]
 
< 40   21 
40 - <65   78 
>= 65   4 
Gender 
[Units: Participants]
 
Female   94 
Male   9 


  Outcome Measures

1.  Primary:   Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)   [ Time Frame: From start of study drug administration until week 182 ]

2.  Secondary:   Maximum Observed Serum Concentration (Cmax) for Sifalimumab   [ Time Frame: Pre-infusion and End of Infusion on Day 1 ]

3.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sifalimumab   [ Time Frame: Pre-infusion and End of Infusion on Day 1 ]

4.  Secondary:   Time to Last Quantifiable Plasma Concentration (Tlast) of Sifalimumab   [ Time Frame: Pre-infusion and End of Infusion on Day 1 ]

5.  Secondary:   Minimum Observed Serum Concentration (Ctrough) of Sifalimumab   [ Time Frame: Pre-infusion and End of Infusion on Day 1 ]

6.  Secondary:   Area Under the Serum Concentration-time Curve Over the Dosing Interval (AUCtau) of Sifalimumab   [ Time Frame: Pre-infusion and End of Infusion on Day 1 ]

7.  Secondary:   Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Sifalimumab   [ Time Frame: Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168 ]

8.  Secondary:   Accumulation Index for Minimum Observed Serum Concentration (Ctrough) of Sifalimumab   [ Time Frame: Pre-infusion and End of Infusion on Day 1 and Week 2, 4, 8, 12, 24, 52, 104, 156 and 168 ]

9.  Secondary:   Number of Participants With Positive Anti-Drug Antibody   [ Time Frame: Day 1 and Week 12, 24, 52, 104, 156 and 168 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
A business decision was made to discontinue the development of sifalimumab in favor of another type 1 interferon (IFN) inhibitor.


  More Information

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: Jerry Green
Organization: MedImmune, LLC
phone: 1-888-483-7729
e-mail: rtpsafety@ppdi.com



Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00979654     History of Changes
Other Study ID Numbers: MI-CP212
First Submitted: September 17, 2009
First Posted: September 18, 2009
Results First Submitted: July 12, 2016
Results First Posted: August 23, 2016
Last Update Posted: October 27, 2016