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Anti-TNF Agents for the Treatment of Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00837434
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : April 14, 2015
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Autoimmunity Centers of Excellence
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Etanercept
Drug: Adalimumab
Enrollment 63
Recruitment Details Participants were to be recruited from seven sites in the United States. Recruitment occurred at six sites. The first site was activated in April 2009. The first participant was randomized in July 2009 and the last participant was randomized in July 2013.
Pre-assignment Details  
Arm/Group Title Etanercept Adalimumab
Hide Arm/Group Description Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks. Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
Period Title: Overall Study
Started 43 20
Completed 34 19
Not Completed 9 1
Reason Not Completed
Physician Decision             3             0
Lost to Follow-up             1             1
Withdrawn by sponsor/regulatory agency             1             0
Noncompliant             2             0
Baseline assessments not done in time             1             0
Unable to obtain study drug             1             0
Arm/Group Title Etanercept Adalimumab Total
Hide Arm/Group Description Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks. Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 39 19 58
Hide Baseline Analysis Population Description
The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either etanercept or adalimumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 19 participants 58 participants
51.7  (9.4) 52.7  (14.0) 52.0  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 19 participants 58 participants
Female
31
  79.5%
15
  78.9%
46
  79.3%
Male
8
  20.5%
4
  21.1%
12
  20.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 19 participants 58 participants
Hispanic or Latino
8
  20.5%
1
   5.3%
9
  15.5%
Not Hispanic or Latino
31
  79.5%
18
  94.7%
49
  84.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 19 participants 58 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  12.8%
1
   5.3%
6
  10.3%
White
30
  76.9%
18
  94.7%
48
  82.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  10.3%
0
   0.0%
4
   6.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 19 participants 58 participants
39 19 58
Detection of Either IgM-Rheumatoid Factor or Antibodies to Cyclic Citrullinated Peptide   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 19 participants 58 participants
Positive 30 14 44
Negative 9 5 14
[1]
Measure Description: Serum IgM-Rheumatoid Factor (IgM RF) is an antibody often present in the blood of a person with rheumatoid arthritis. Positive value for RF: >/=0.5 IU/mL. Negative value for RF: <0.5 IU/mL. Presence of IgM RF indicates aggressive rheumatoid arthritis (RA) and higher risk of joint damage. Antibodies to Cyclic Citrullinated Peptide (anti-CCP) is often detected in in the blood of individuals with RA. Positive value for anti-CCP: >/=8 IU/mL. Negative value for anti-CCP: <8 IU/mL. High anti-CCP indicates an aggressive RA and a higher risk of joint damage.
Detection of IgM-Rheumatoid Factor (IgM RF)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 19 participants 58 participants
Positive 24 9 33
Negative 15 10 25
[1]
Measure Description: Serum IgM RF is an antibody often present in the blood of a person with rheumatoid arthritis. Positive value for RF: >/=0.5 IU/mL. Negative value for RF: <0.5 IU/mL. Presence of IgM RF indicates aggressive rheumatoid arthritis (RA) and higher risk of joint damage.
Detection of Antibodies to Cyclic Citrullinated Antibody Peptide   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 19 participants 58 participants
Positive 25 11 36
Negative 14 8 22
[1]
Measure Description: Anti-CCP is often present in the blood of individuals with RA. Positive value for anti-CCP: >/=8 IU/mL. Negative value for anti-CCP: <8 IU/mL. High anti-CCP indicates an aggressive RA and a higher risk of joint damage.
Methotrexate Dosage   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg
Number Analyzed 39 participants 19 participants 58 participants
17.4  (4.0) 18.8  (3.8) 17.9  (3.9)
[1]
Measure Description: Participants were required to be on a stable dose of methotrexate to be enrolled in the study. Stable dose definition: between 7.5 mg and 25 mg by mouth or subcutaneously weekly for at least 8 weeks prior to randomization.
Years with Rheumatoid Arthritis   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 19 participants 58 participants
5.8  (7.7) 4.3  (5.2) 5.3  (7.0)
[1]
Measure Description: Years since diagnosis of rheumatoid arthritis by a physician. Participants were required to be diagnosed with Rheumatoid Arthritis at least 3 months before enrolling in the study.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 39 participants 19 participants 58 participants
1.4  (0.7) 1.3  (0.6) 1.4  (0.7)
[1]
Measure Description: HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do). In addition, category scores are modified if an aid or device is used, for example, a walker, or help is received from another person in the daily living activities. Scores from each of the 8 categories are totaled and can range from 0 to 24.
C-reactive Protein (CRP) Level   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 39 participants 19 participants 58 participants
14.1  (25.5) 13.3  (24.3) 13.8  (24.9)
[1]
Measure Description: CRP is an acute phase reactant that is used to identify the presence of nonspecific inflammation. The CRP normal reference range depends on the laboratory. In this study the upper limit of normal ranged from 4 to 10.9 mg/L. An increased CRP level indicated the presence of inflammation. A low CRP may mean an absence of inflammation.
Tender Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 39 participants 19 participants 58 participants
12.2  (6.6) 12.6  (7.2) 12.3  (6.7)
[1]
Measure Description: Tender Joint Count (TJC) is calculated based on tenderness response of 28 joints examined. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness.
Swollen Joint Count at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Joints
Number Analyzed 39 participants 19 participants 58 participants
9.9  (6.2) 9.4  (5.9) 9.7  (6.0)
[1]
Measure Description: Swollen Joint Count (SJC) is calculated based on swelling response of 28 joints examined. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling.
Patient’s Global Assessment of Disease Activity- Visual Analog Scale (PtGADA-VAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 39 participants 19 participants 58 participants
5.9  (2.6) 7.3  (2.0) 6.4  (2.5)
[1]
Measure Description: A self-reported measure of perceived disease activity obtained by responding to the question "considering all the ways that your arthritis affects you, rate how you are doing on the following scale by placing a vertical mark." A vertical mark on a 10 cm line rated 0 (very well) to 10 (very bad) determines the score. The range: 0 to 10, with 10 being severe symptoms).
Disease Activity Score Using C-reactive Protein (DAS28-CRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 39 participants 19 participants 58 participants
5.2  (1.0) 5.4  (0.7) 5.3  (0.9)
[1]
Measure Description: The DAS28 is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein (CRP) in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).
1.Primary Outcome
Title Percentage of CD27+ Switched Memory B Cells at Week 12
Hide Description Analysis of the steady state composition of the B cell compartment were performed using ex-vivo multicolor flow cytometry on Ficoll isolated peripheral blood mononuclear cells (PBMCs). CD27+ switched memory B cells are a subset of B cells and are assessed by flow cytometry. CD27+ switched memory B cells are expressed as a percent of B cells. Lower CD27+ memory B cells indicate a decrease in the generation of B cell memory which may be caused by blocking lymphotoxin (LT) and tumor necrosis factor (TNF) signaling.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol population includes subjects with a baseline and week 12 (plus or minus 1 week) assessment that received at least 75% of the planned doses of either etanercept or adalimumab prior to week 12 and who did not have any serious protocol deviations.
Arm/Group Title Etanercept Adalimumab
Hide Arm/Group Description:
Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
Overall Number of Participants Analyzed 30 18
Mean (Standard Deviation)
Unit of Measure: Percentage of B Cells
13.2  (7.3) 13.8  (7.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Adalimumab
Comments Null Hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 does not differ between individuals treated with etanercept and those treated with adalimumab after adjusting for baseline CD27+ switched memory cells. Alt. hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 in individuals treated with etanercept is lower than in those treated with adalimumab after adjusting for baseline CD27+ switched memory cells.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3
Comments [Not Specified]
Method ANCOVA
Comments P-value for testing treatment effect uses week 12 CD27+ switched memory as the outcome variable and adjusts for baseline CD27+ switched memory
2.Secondary Outcome
Title Percentage of Participants Fulfilling DAS-28-CRP “Good or Moderate Response” Criteria at Week 12
Hide Description Good responders: change in DAS28-CRP (Baseline-Week12) > 1.2 and Week 12 DAS-CRP score was <\= 3.2. If the conditions for non-response* or good response were not met, the DAS28-CRP response was considered moderate. Participants with measurements for designated time points were included in the analysis. [*Non-responders had any of 4 conditions: change in DAS28-CRP (Baseline –Week 12) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 12) < 1.2 with Week 12 DAS28-CRP score > 5.1; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <\= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point].
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.
Arm/Group Title Etanercept Adalimumab
Hide Arm/Group Description:
Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
Overall Number of Participants Analyzed 37 19
Measure Type: Number
Unit of Measure: percentage of participants
86.5 89.5
3.Secondary Outcome
Title Percentage of Participants Fulfilling DAS-28-CRP "Good or Moderate Response" Criteria at Week 24
Hide Description Good responders had: change in DAS28-CRP (Baseline-Week 24) > 1.2 and the Week 24 DAS-CRP score was <= 3.2. If the conditions for non-response* or good response were not met then the DAS28-CRP response was considered moderate.[*Non-responders had any of the 4 conditions: change in DAS28-CRP (Baseline –Week 24) <0.6; 0.6 <\= change in DAS28-CRP ( Baseline-Week 24) < 1.2 with Week 24 DAS28-CRP score > 5.1 ; a flare that required prednisone > 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to <= 10 mg/day by Week 8; or the participant required prednisone > 20 mg/day at any time point]. Participants with measurements for designated time points were included in the analysis.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.
Arm/Group Title Etanercept Adalimumab
Hide Arm/Group Description:
Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
Overall Number of Participants Analyzed 34 19
Measure Type: Number
Unit of Measure: percentage of participants
88.2 84.2
4.Secondary Outcome
Title Percentage of Participants Meeting ACR20 Response Criteria at Week 12
Hide Description

The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:

  • Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
  • Patient's global assessment of disease activity (VAS 100 mm)
  • Physician's global assessment of disease activity (VAS 100 mm)
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
  • Acute phase reactant (CRP).

Participants with measurements for designated time points were included in the analysis.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.
Arm/Group Title Etanercept Adalimumab
Hide Arm/Group Description:
Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
Overall Number of Participants Analyzed 37 19
Measure Type: Number
Unit of Measure: percentage of participants
67.6 73.7
5.Secondary Outcome
Title Percentage of Participants Meeting ACR20 Response Criteria at Week 24
Hide Description

The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:

  • Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
  • Patient's global assessment of disease activity (VAS 100 mm)
  • Physician's global assessment of disease activity (VAS 100 mm)
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
  • Acute phase reactant (CRP).

Participants with measurements for designated time points were included in the analysis.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.
Arm/Group Title Etanercept Adalimumab
Hide Arm/Group Description:
Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
Overall Number of Participants Analyzed 34 19
Measure Type: Number
Unit of Measure: percentage of participants
73.5 84.2
6.Secondary Outcome
Title Percentage of Participants Meeting ACR50 Response Criteria at Week 12
Hide Description

The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:

  • Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
  • Patient's global assessment of disease activity (VAS 100 mm)
  • Physician's global assessment of disease activity (VAS 100 mm)
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
  • Acute phase reactant (CRP).

Participants with measurements for designated time points were included in the analysis.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.
Arm/Group Title Etanercept Adalimumab
Hide Arm/Group Description:
Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
Overall Number of Participants Analyzed 37 19
Measure Type: Number
Unit of Measure: percentage of participants
29.7 47.4
7.Secondary Outcome
Title Percentage of Participants Meeting ACR50 Response Criteria at Week 24
Hide Description

The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:

  • Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)
  • Patient's global assessment of disease activity (VAS 100 mm)
  • Physician's global assessment of disease activity (VAS 100 mm)
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
  • Acute phase reactant (CRP).

Participants with measurements for designated time points were included in the analysis.

Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.
Arm/Group Title Etanercept Adalimumab
Hide Arm/Group Description:
Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
Overall Number of Participants Analyzed 34 19
Measure Type: Number
Unit of Measure: percentage of participants
38.2 63.2
Time Frame From the time of administration of the first dose of study drug until the participant completed study participation, an average of 24 weeks, or until 30 days after the participant prematurely withdrew.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept Adalimumab
Hide Arm/Group Description Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks. Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
All-Cause Mortality
Etanercept Adalimumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept Adalimumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/39 (5.13%)      1/19 (5.26%)    
Gastrointestinal disorders     
Gastrooesophageal reflux disease  1  1/39 (2.56%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Rheumatoid arthritis  1  0/39 (0.00%)  0 1/19 (5.26%)  1
Psychiatric disorders     
Suicide attempt  1  1/39 (2.56%)  1 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Etanercept Adalimumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/39 (79.49%)      17/19 (89.47%)    
Blood and lymphatic system disorders     
Anaemia  1  9/39 (23.08%)  9 3/19 (15.79%)  3
Leukopenia  1  4/39 (10.26%)  7 2/19 (10.53%)  2
Lymphopenia  1  5/39 (12.82%)  5 3/19 (15.79%)  5
Neutropenia  1  3/39 (7.69%)  5 1/19 (5.26%)  1
Gastrointestinal disorders     
Nausea  1  2/39 (5.13%)  2 1/19 (5.26%)  1
General disorders     
Fatigue  1  1/39 (2.56%)  1 2/19 (10.53%)  2
Infections and infestations     
Bronchitis  1  4/39 (10.26%)  4 2/19 (10.53%)  2
Gastroenteritis  1  2/39 (5.13%)  2 1/19 (5.26%)  1
Nasopharyngitis  1  4/39 (10.26%)  4 3/19 (15.79%)  4
Upper respiratory tract infection  1  4/39 (10.26%)  5 1/19 (5.26%)  1
Investigations     
Alanine aminotransferase increased  1  7/39 (17.95%)  9 4/19 (21.05%)  4
Aspartate aminotransferase increased  1  10/39 (25.64%)  12 3/19 (15.79%)  3
Blood creatinine increased  1  5/39 (12.82%)  6 1/19 (5.26%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/39 (12.82%)  5 1/19 (5.26%)  1
Back pain  1  3/39 (7.69%)  3 0/19 (0.00%)  0
Pain in extremity  1  5/39 (12.82%)  6 2/19 (10.53%)  2
Nervous system disorders     
Headache  1  6/39 (15.38%)  6 1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/39 (7.69%)  3 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis contact  1  3/39 (7.69%)  3 0/19 (0.00%)  0
Rash  1  4/39 (10.26%)  4 2/19 (10.53%)  2
Vascular disorders     
Hypertension  1  2/39 (5.13%)  2 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Director, Clinical Research Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00837434     History of Changes
Other Study ID Numbers: DAIT ARA06
First Submitted: February 3, 2009
First Posted: February 5, 2009
Results First Submitted: March 18, 2015
Results First Posted: April 14, 2015
Last Update Posted: December 10, 2018