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Trial record 4 of 8 for:    "Iritis"

Human Anti-Tac (Daclizumab) to Treat Juvenile Idiopathic Arthritis (JIA)-Associated Uveitis

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ClinicalTrials.gov Identifier: NCT00130637
Recruitment Status : Completed
First Posted : August 15, 2005
Results First Posted : September 29, 2010
Last Update Posted : January 30, 2017
Sponsor:
Collaborator:
The Emmes Company, LLC
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anterior Uveitis
Arthritis, Juvenile Idiopathic
Iritis
Immunosuppression
Intervention Drug: Daclizumab
Enrollment 6
Recruitment Details single center, 6 participants
Pre-assignment Details pilot, non-randomized, open-label trial
Arm/Group Title Daclizumab
Hide Arm/Group Description An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
Period Title: Overall Study
Started 6
Completed 3
Not Completed 3
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             1
Arm/Group Title Daclizumab
Hide Arm/Group Description An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
6
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
10.2  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
4
  66.7%
Male
2
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Number of Participants With a Two-step Reduction in Inflammation
Hide Description Number of participants with a two-step reduction (or down to 0 out of a scale of 0 to 4+) of anterior chamber (AC) inflammation according to Standardization of Uveitis Nomenclature (SUN) criteria, while on a topical corticosteroid schedule of less than 3 times a day. Grade 0 is the best score on this scale with <1 cell in the field and 4+ is the worst score on this scale with >50 cells in the field.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daclizumab
Hide Arm/Group Description:
An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
5
2.Primary Outcome
Title Number of Participants Reporting a Serious Adverse Event (SAE)
Hide Description Safety of acute daclizumab use in JIA-associated uveitis was assessed through serious adverse events (SAE).
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daclizumab
Hide Arm/Group Description:
An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participant
1
Time Frame Adverse event data were collected during the 52 week study period
Adverse Event Reporting Description Event descriptions were not mapped to a standardized term. General disorders was chosen as the organ system for events categorized as "Other" or "Pain".
 
Arm/Group Title Daclizumab
Hide Arm/Group Description An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
All-Cause Mortality
Daclizumab
Affected / at Risk (%)
Total   0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Daclizumab
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Cardiac disorders   
palpitations * 1 [1]  1/6 (16.67%)  1
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[1]
palpitations with normal echocardiogram (ECG), patient hospitalized for observation
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Daclizumab
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
Decreased Hgb and Hct * 1  1/6 (16.67%)  1
Elevated WBC * 1  2/6 (33.33%)  2
Low Hgb and Hct * 1  2/6 (33.33%)  2
Low platelets * 1  1/6 (16.67%)  1
Low White Blood Count * 1  1/6 (16.67%)  1
Nose bleed * 1  1/6 (16.67%)  1
Cardiac disorders   
Occasional Light headiness * 1  1/6 (16.67%)  1
Eye disorders   
Squinting OU * 1  1/6 (16.67%)  1
Gastrointestinal disorders   
Decreased appetite with associated nausea * 1  1/6 (16.67%)  1
Ruptured blister inner lower lip * 1  1/6 (16.67%)  1
Vomiting * 1  1/6 (16.67%)  1
General disorders   
lower extremity edema * 1 [1]  1/6 (16.67%)  1
Aphtous ulcer on right lower gum * 1  1/6 (16.67%)  1
Back Pain * 1  1/6 (16.67%)  1
Erythematous area of Lower Eyelid * 1  1/6 (16.67%)  1
Headache * 1  1/6 (16.67%)  1
Headaches/Back Pain * 1  1/6 (16.67%)  1
Hot Flashes * 1  1/6 (16.67%)  1
Knee Pain * 1  1/6 (16.67%)  1
Mild myalgia in legs * 1  1/6 (16.67%)  1
Mild pain left knee and hip after playing soccer. * 1  1/6 (16.67%)  1
mild right shoulder pain * 1  1/6 (16.67%)  1
Mild shoulder pain * 1  1/6 (16.67%)  1
Mouth Sores * 1  1/6 (16.67%)  2
Mucous membrane Ulcers * 1  1/6 (16.67%)  1
Neck and Lower back pain * 1  1/6 (16.67%)  1
Pain Right great toe * 1  1/6 (16.67%)  1
Painful Right Wrist * 1  1/6 (16.67%)  1
Photophobia * 1  1/6 (16.67%)  1
Right knee pain without inflammation * 1  1/6 (16.67%)  1
Right Knee Pain few hrs after prolonged exertion * 1  1/6 (16.67%)  1
Slightly Swollen right anterior pilla of tonsil * 1  1/6 (16.67%)  1
Tooth Extraction * 1  1/6 (16.67%)  1
Hepatobiliary disorders   
Planter tenderness * 1  1/6 (16.67%)  1
Immune system disorders   
Allergy symptoms * 1  1/6 (16.67%)  1
Infections and infestations   
herpes zoster skin infection * 1 [2]  1/6 (16.67%)  1
Cold Symptoms/Sore throat * 1  1/6 (16.67%)  1
Stomach virus * 1  1/6 (16.67%)  1
Gum abscess * 1  1/6 (16.67%)  1
Nasal congestion causing right ear pain * 1  1/6 (16.67%)  1
Persistent cough * 1  1/6 (16.67%)  1
Pustules over abdominal area * 1  1/6 (16.67%)  1
Runny Nose * 1  1/6 (16.67%)  1
Rash * 1 [3]  1/6 (16.67%)  1
Sore Throat, fever, body ache * 1  1/6 (16.67%)  1
Sore Throat, Low grade fever, Malaise * 1  1/6 (16.67%)  1
Stomach Flu * 1  1/6 (16.67%)  1
Stuffy Nose and Sore Throat * 1  1/6 (16.67%)  1
Tonsilitis with associated fever * 1  1/6 (16.67%)  1
Upper respiratory Infection * 1  2/6 (33.33%)  2
Throat infection * 1  1/6 (16.67%)  1
Slight cold * 1  1/6 (16.67%)  1
Metabolism and nutrition disorders   
Elevated AST * 1  3/6 (50.00%)  3
Elevated Cholesterol level * 1  1/6 (16.67%)  1
Elevated CPK * 1  1/6 (16.67%)  1
Elevated potassium level * 1  1/6 (16.67%)  1
Slight increase in total bilirubin * 1  1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders   
Ankle stiffness * 1  1/6 (16.67%)  1
Bilateral Hand and wrists inflammation, Mild Pain * 1  1/6 (16.67%)  1
Elevated ESR * 1  1/6 (16.67%)  1
Right Thumb sore and swollen * 1  1/6 (16.67%)  1
Systemic Joint Inflammation, & assoc. joint pain. * 1  1/6 (16.67%)  1
Renal and urinary disorders   
Elevated Urine WBC * 1  1/6 (16.67%)  1
Occasional dysuria * 1  1/6 (16.67%)  1
Slight Leukocyte esterase increase * 1  1/6 (16.67%)  1
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[1]
Verbatim event description reported by site staff was "bilateral ankle swelling and associating pain". This event was secondary to naproxen as it resolved upon discontinuation of naproxen
[2]
Verbatim event description reported by site staff was "maculopapular rash (positive for varicella virus)"
[3]
Verbatim event description reported by site staff was "scabies, rash chest, under arms and inner thighs"
The results of this trial need to be interpreted cautiously because of the small number of patients, the heterogeneity of the patient population (such as one participant with systemic JIA), and the nonrandomized and unmasked nature of the trial.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: H. Nida Sen, MD, MHS
Organization: National Eye Institute, NIH
Phone: 301-435-5139
EMail: senh@nei.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier: NCT00130637     History of Changes
Other Study ID Numbers: 050208
05-EI-0208
First Submitted: August 12, 2005
First Posted: August 15, 2005
Results First Submitted: August 12, 2010
Results First Posted: September 29, 2010
Last Update Posted: January 30, 2017