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Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome (REMITTER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00465985
First received: April 25, 2007
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
Results First Received: November 16, 2010  
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: Muckle Wells Syndrome
Interventions: Drug: ACZ885
Drug: Placebo

  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
ACZ885 ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
Placebo Placebo subcutaneous injection every 8 weeks.

Participant Flow for 3 periods

 Period 1:   Part I - Open-label Treatment Period
    ACZ885     Placebo  
STARTED     35 [1]   0  
COMPLETED     31 [2]   0  
NOT COMPLETED     4     0  
Unsatisfactory therapeutic effect                 4                 0  
[1] All patients received treatment with ACZ885 in Part I of the study.
[2] Only patients with a complete response completed Part I and entered Part II of the study.

Period 2:   Part II - 1:1 ACZ885:Placebo
    ACZ885     Placebo  
STARTED     15 [1]   16  
COMPLETED     15     4  
NOT COMPLETED     0     12  
Unsatisfactory therapeutic effect                 0                 12  
[1] Patients with complete response to treatment entered Part II and were randomized to ACZ885 ,placebo.

Period 3:   Part III - Open-label Treatment Period
    ACZ885     Placebo  
STARTED     31 [1]   0  
COMPLETED     29     0  
NOT COMPLETED     2     0  
Unsatisfactory therapeutic effect                 1                 0  
Adverse Event                 1                 0  
[1] All patients received treatment with ACZ885 in Part III of the study.



  Baseline Characteristics
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Reporting Groups
  Description
ACZ885 ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.

Baseline Measures
    ACZ885  
Number of Participants  
[units: participants]
 		  35  
Age  
[units: years]
Mean ± Standard Deviation 		  34  ± 14.89  
Gender  
[units: participants]
 		 
Female     25  
Male     10  



  Outcome Measures
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1.  Primary:   Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part)   [ Time Frame: 32 weeks after study start ]
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2.  Primary:   Number of Participants Who Experienced a Disease Flare in Part II   [ Time Frame: 32 weeks after study start ]
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3.  Secondary:   Number of Participants With Treatment Response in Part I (After 8 Weeks)   [ Time Frame: 8 weeks after study start ]
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4.  Secondary:   Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part)   [ Time Frame: 32 weeks after study start ]
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5.  Secondary:   Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8.   [ Time Frame: Week 8 and Week 32 ]
  Show Outcome Measure 5

6.  Secondary:   Pharmacokinetics (CLD (L/d))   [ Time Frame: 48 weeks after study start ]
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7.  Secondary:   Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part I.   [ Time Frame: until Week 8 ]
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8.  Secondary:   Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part II.   [ Time Frame: 32 weeks after study start ]
  Show Outcome Measure 8

9.  Secondary:   Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part III.   [ Time Frame: 48 weeks after study start ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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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.


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
The outcomes for this study were reported in separate tables for each period. The SAE and AEs were reported in all in one table.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00465985     History of Changes
Other Study ID Numbers: CACZ885D2304
Study First Received: April 25, 2007
Results First Received: November 16, 2010
Last Updated: July 31, 2012
Health Authority: United States: Food and Drug Administration
Germany: Paul Ehrlich Institute
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
India: Ministry of Health