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Trial record 12 of 16 for:    "Muckle-Wells syndrome"

Interleukin-1 Trap to Treat Autoinflammatory Diseases

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ClinicalTrials.gov Identifier: NCT00094900
Recruitment Status : Completed
First Posted : October 28, 2004
Results First Posted : July 10, 2013
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Inflammation
Familial Mediterranean Fever
Still's Disease, Adult-Onset
Intervention: Drug: IL-1 Trap

  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
No text entered.

Reporting Groups
  Description
IL-1 Trap Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured

Participant Flow:   Overall Study
    IL-1 Trap
STARTED   11 
COMPLETED   10 
NOT COMPLETED   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
IL-1 Trap Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured

Baseline Measures
   IL-1 Trap 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   11 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   4 
Male   7 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   1 
Not Hispanic or Latino   10 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   11 
More than one race   0 
Unknown or Not Reported   0 


  Outcome Measures

1.  Primary:   Mean Change in Daily Scores   [ Time Frame: 10 days for 4 patient, 6 days for 1 patient ]

2.  Primary:   Mean Change in ESR   [ Time Frame: 10 days for 4 patient, 6 days for 1 patient ]

3.  Primary:   Mean Change in hsCRP   [ Time Frame: 10 days for 4 patient, 6 days for 1 patient ]

4.  Primary:   Mean Change in SAA   [ Time Frame: 10 days for 4 patient, 6 days for 1 patient ]

5.  Primary:   Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease   [ Time Frame: 24 months ]

6.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS   [ Time Frame: 3 months ]

7.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS   [ Time Frame: 6 months ]

8.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS   [ Time Frame: 9 months ]

9.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS   [ Time Frame: 12 months ]

10.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS   [ Time Frame: 16 months ]

11.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS   [ Time Frame: 20 months ]

12.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS   [ Time Frame: 24 months ]

13.  Secondary:   Mean Change in Physician’s Global Assessment, by VAS   [ Time Frame: 3 months ]

14.  Secondary:   Mean Change in Physician’s Global Assessment, by VAS   [ Time Frame: 6 months ]

15.  Secondary:   Mean Change in Physician’s Global Assessment, by VAS   [ Time Frame: 9 months ]

16.  Secondary:   Mean Change in Physician’s Global Assessment, by VAS   [ Time Frame: 12 months ]

17.  Secondary:   Mean Change in Physician’s Global Assessment, by VAS   [ Time Frame: 16 months ]

18.  Secondary:   Mean Change in Physician’s Global Assessment, by VAS   [ Time Frame: 20 months ]

19.  Secondary:   Mean Change in Physician’s Global Assessment, by VAS   [ Time Frame: 24 months ]

20.  Secondary:   Mean Change in Patient’s Assessment of Pain, by VAS   [ Time Frame: 3 months ]

21.  Secondary:   Mean Change in Patient’s Assessment of Pain, by VAS   [ Time Frame: 6 months ]

22.  Secondary:   Mean Change in Patient’s Assessment of Pain, by VAS   [ Time Frame: 9 months ]

23.  Secondary:   Mean Change in Patient’s Assessment of Pain, by VAS   [ Time Frame: 12 months ]

24.  Secondary:   Mean Change in Patient’s Assessment of Pain, by VAS   [ Time Frame: 16 months ]

25.  Secondary:   Mean Change in Patient’s Assessment of Pain, by VAS   [ Time Frame: 20 months ]

26.  Secondary:   Mean Change in Patient’s Assessment of Pain, by VAS   [ Time Frame: 24 months ]

27.  Secondary:   Mean Change in Patient’s Assessment of Fatigue, by VAS   [ Time Frame: 3 months ]

28.  Secondary:   Mean Change in Patient’s Assessment of Fatigue, by VAS   [ Time Frame: 6 months ]

29.  Secondary:   Mean Change in Patient’s Assessment of Fatigue, by VAS   [ Time Frame: 9 months ]

30.  Secondary:   Mean Change in Patient’s Assessment of Fatigue, by VAS   [ Time Frame: 12 months ]

31.  Secondary:   Mean Change in Patient’s Assessment of Fatigue, by VAS   [ Time Frame: 16 months ]

32.  Secondary:   Mean Change in Patient’s Assessment of Fatigue, by VAS   [ Time Frame: 20 months ]

33.  Secondary:   Mean Change in Patient’s Assessment of Fatigue, by VAS   [ Time Frame: 24 months ]

34.  Secondary:   Mean Change in Tender Joint Count   [ Time Frame: 3 months ]

35.  Secondary:   Mean Change in Tender Joint Count.   [ Time Frame: 6 months ]

36.  Secondary:   Mean Change in Tender Joint Count   [ Time Frame: 9 months ]

37.  Secondary:   Mean Change in Tender Joint Count   [ Time Frame: 12 months ]

38.  Secondary:   Mean Change in Tender Joint Count   [ Time Frame: 16 months ]

39.  Secondary:   Mean Change in Tender Joint Count   [ Time Frame: 20 months ]

40.  Secondary:   Mean Change in Tender Joint Count   [ Time Frame: 24 months ]

41.  Secondary:   Mean Change in Swollen Joint Count   [ Time Frame: 3 months ]

42.  Secondary:   Mean Change in Swollen Joint Count   [ Time Frame: 6 months ]

43.  Secondary:   Mean Change in Swollen Joint Count   [ Time Frame: 9 months ]

44.  Secondary:   Mean Change in Swollen Joint Count   [ Time Frame: 12 months ]

45.  Secondary:   Mean Change in Swollen Joint Count   [ Time Frame: 16 months ]

46.  Secondary:   Mean Change in Swollen Joint Count   [ Time Frame: 20 months ]

47.  Secondary:   Mean Change in Swollen Joint Count   [ Time Frame: 24 months ]

48.  Secondary:   Mean Change in SF-36 Physical Component Score   [ Time Frame: 3 months ]

49.  Secondary:   Mean Change in SF-36 Physical Component Score   [ Time Frame: 6 months ]

50.  Secondary:   Mean Change in SF-36 Physical Component Score   [ Time Frame: 9 months ]

51.  Secondary:   Mean Change in SF-36 Physical Component Score   [ Time Frame: 12 months ]

52.  Secondary:   Mean Change in SF-36 Physical Component Score   [ Time Frame: 16 months ]

53.  Secondary:   Mean Change in SF-36 Physical Component Score   [ Time Frame: 20 months ]

54.  Secondary:   Mean Change in SF-36 Physical Component Score   [ Time Frame: 24 months ]

55.  Secondary:   Mean Change in SF-36 Mental Component Score   [ Time Frame: 3 months ]

56.  Secondary:   Mean Change in SF-36 Mental Component Score   [ Time Frame: 6 months ]

57.  Secondary:   Mean Change in SF-36 Mental Component Score   [ Time Frame: 9 months ]

58.  Secondary:   Mean Change in SF-36 Mental Component Score   [ Time Frame: 12 months ]

59.  Secondary:   Mean Change in SF-36 Mental Component Score   [ Time Frame: 16 months ]

60.  Secondary:   Mean Change in SF-36 Mental Component Score   [ Time Frame: 20 months ]

61.  Secondary:   Mean Change in SF-36 Mental Component Score   [ Time Frame: 24 months ]

62.  Secondary:   Mean Change in WBCs   [ Time Frame: 3 months ]

63.  Secondary:   Mean Change in WBCs   [ Time Frame: 6 months ]

64.  Secondary:   Mean Change in WBCs   [ Time Frame: 12 months ]

65.  Secondary:   Mean Change in WBCs   [ Time Frame: 24 months ]

66.  Secondary:   Mean Change in Ferritin   [ Time Frame: 3 months ]

67.  Secondary:   Mean Change in Ferritin   [ Time Frame: 6 months ]

68.  Secondary:   Mean Change in Ferritin   [ Time Frame: 12 months ]

69.  Secondary:   Mean Change in Ferritin   [ Time Frame: 24 months ]

70.  Secondary:   Mean Change in Serum Amyloid A   [ Time Frame: 3 months ]

71.  Secondary:   Mean Change in Serum Amyloid A   [ Time Frame: 6 months ]

72.  Secondary:   Mean Change in Serum Amyloid A   [ Time Frame: 12 months ]

73.  Secondary:   Mean Change in Serum Amyloid A   [ Time Frame: 24 months ]

74.  Secondary:   Mean Change in C-Reactive Protein   [ Time Frame: 3 months ]

75.  Secondary:   Mean Change in C-Reactive Protein   [ Time Frame: 6 months ]

76.  Secondary:   Mean Change in C-Reactive Protein   [ Time Frame: 12 months ]

77.  Secondary:   Mean Change in C-Reactive Protein   [ Time Frame: 24 months ]

78.  Secondary:   Mean Change in Erythrocyte Sedimentation Rate   [ Time Frame: 3 months ]

79.  Secondary:   Mean Change in Erythrocyte Sedimentation Rate   [ Time Frame: 6 months ]

80.  Secondary:   Mean Change in Erythrocyte Sedimentation Rate   [ Time Frame: 12 months ]

81.  Secondary:   Mean Change in Erythrocyte Sedimentation Rate   [ Time Frame: 24 months ]

82.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects   [ Time Frame: 3 months ]

83.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects   [ Time Frame: 6 months ]

84.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects   [ Time Frame: 12 months ]

85.  Secondary:   Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects   [ Time Frame: 24 months ]

86.  Secondary:   Mean Change in Tender Joint Count in AOSD Subjects   [ Time Frame: 3 months ]

87.  Secondary:   Mean Change in Tender Joint Count in AOSD Subjects   [ Time Frame: 6 months ]

88.  Secondary:   Mean Change in Tender Joint Count in AOSD Subjects   [ Time Frame: 12 months ]

89.  Secondary:   Mean Change in Tender Joint Count in AOSD Subjects   [ Time Frame: 24 months ]

90.  Secondary:   Mean Change in Swollen Joint Count in AOSD Subjects   [ Time Frame: 3 months ]

91.  Secondary:   Mean Change in Swollen Joint Count in AOSD Subjects   [ Time Frame: 6 months ]

92.  Secondary:   Mean Change in Swollen Joint Count in AOSD Subjects   [ Time Frame: 12 months ]

93.  Secondary:   Mean Change in Swollen Joint Count in AOSD Subjects   [ Time Frame: 24 months ]

94.  Secondary:   Mean Change in Prednisone Dose   [ Time Frame: 3 months ]

95.  Secondary:   Mean Change in Prednisone Dose   [ Time Frame: 6 months ]

96.  Secondary:   Mean Change in Prednisone Dose   [ Time Frame: 12 months ]

97.  Secondary:   Mean Change in Prednisone Dose   [ Time Frame: 24 months ]


  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

Secondary outcome analyses will be stratified based on primary outcome results - responders and non-responders.

1 subject with Familial Mediterranean Fever (FMF) was recruited but outcomes were not collected due to insufficient accrual of FMF cases.



  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Raphaela Goldbach-Mansky, MD
Organization: National Inst of Arthritis and Musculoskeletal and Skin Diseases
phone: 13014356243
e-mail: goldbacr@mail.nih.gov


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

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )
ClinicalTrials.gov Identifier: NCT00094900     History of Changes
Other Study ID Numbers: 050014
05-AR-0014
First Submitted: October 28, 2004
First Posted: October 28, 2004
Results First Submitted: March 19, 2013
Results First Posted: July 10, 2013
Last Update Posted: March 4, 2014