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Trial record 77 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

Rituximab and Belimumab for Lupus Nephritis (CALIBRATE)

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ClinicalTrials.gov Identifier: NCT02260934
Recruitment Status : Completed
First Posted : October 9, 2014
Results First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
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: None (Open Label);   Primary Purpose: Treatment
Condition Lupus Nephritis
Interventions Biological: Rituximab
Drug: Cyclophosphamide
Drug: Prednisone
Drug: Methylprednisolone
Drug: Diphenhydramine
Drug: Acetaminophen
Biological: Belimumab
Enrollment 43
Recruitment Details Of the 59 participants screened, 43 were enrolled at 14 sites in the US from July 9, 2015 to May 22, 2017.
Pre-assignment Details Prior to randomization, enrolled participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper. Participants were randomized at Week 4.
Arm/Group Title Rituximab/Cyclophosphamide (RC) Rituximab/Cyclophosphamide/Belimumab (RCB)
Hide Arm/Group Description Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Period Title: Overall Study
Started 22 21
Completed 9 [1] 7 [2]
Not Completed 13 14
Reason Not Completed
Lost to Follow-up             2             1
Withdrawal by Subject             0             2
Participant Relocated             1             0
On Study             10             11
[1]
At primary outcome timepoint: Ten participants engaged in ongoing scheduled study visits.
[2]
At primary outcome timepoint: Eleven participants engaged in ongoing scheduled study visits.
Arm/Group Title Rituximab/Cyclophosphamide (RC) Rituximab/Cyclophosphamide/Belimumab (RCB) Total
Hide Arm/Group Description Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone. Total of all reporting groups
Overall Number of Baseline Participants 22 21 43
Hide Baseline Analysis Population Description
Participants who signed informed consent and were enrolled in the study. Reported baseline measurements are the most recent measurements for a participant taken between the Screening Visit (occurring within 21 days of Week 0/Study Enrollment) and Week 0 (Study Enrollment).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 43 participants
32.3  (11.4) 34.5  (9.1) 33.4  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Female
18
  81.8%
19
  90.5%
37
  86.0%
Male
4
  18.2%
2
   9.5%
6
  14.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Hispanic or Latino
10
  45.5%
5
  23.8%
15
  34.9%
Not Hispanic or Latino
12
  54.5%
16
  76.2%
28
  65.1%
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 22 participants 21 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  13.6%
2
   9.5%
5
  11.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  40.9%
8
  38.1%
17
  39.5%
White
7
  31.8%
9
  42.9%
16
  37.2%
More than one race
1
   4.5%
1
   4.8%
2
   4.7%
Unknown or Not Reported
2
   9.1%
1
   4.8%
3
   7.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 21 participants 43 participants
22 21 43
Urine Protein-to-Creatinine Ratio (UPCR) from 24 Hour Collection   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 22 participants 21 participants 43 participants
3.4  (1.5) 3.3  (2.5) 3.4  (2.0)
[1]
Measure Description: Urine protein-to-creatinine ratio (UPCR) from a 24-hour collection is a measure of lupus nephritis disease activity. Higher ratios indicate poorer kidney function. Elevated ratio: >3.
Elevated Urine Protein-to-Creatinine Ratio (UPCR)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
14
  63.6%
8
  38.1%
22
  51.2%
[1]
Measure Description: Count of participants with a urine protein-to-creatinine ratio (UPCR) from a 24-hour collection that was >3.
Serum Creatinine   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 22 participants 21 participants 43 participants
1.0  (0.4) 1.0  (0.5) 1.0  (0.4)
[1]
Measure Description: Serum creatinine is a measure of renal function. Normal values: 0.67 to 1.18mg/dL for men and 0.51 to 0.95mg/dL for women. Higher results indicate poorer kidney function.
Estimated glomerular filtration rate (eGFR)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73m^2
Number Analyzed 22 participants 21 participants 43 participants
92.7  (36.0) 89.1  (33.9) 90.9  (34.6)
[1]
Measure Description: Estimated glomerular filtration rate (eGFR) is a measure of renal function. Methodology: Calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula based on serum creatinine, age, sex and race. Normal GFR: ≥90 mL/min/1.73m^2. Lower GFRs reflect poorer kidney function.
Serum Albumin   [1] 
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 22 participants 21 participants 43 participants
3.0  (0.5) 2.9  (0.6) 2.9  (0.6)
[1]
Measure Description: Normal values: 3.7 to 4.9 g/dL.
B Cell Count   [1] 
Mean (Standard Deviation)
Unit of measure:  cells/uL
Number Analyzed 22 participants 21 participants 43 participants
160.5  (157.4) 216.0  (207.3) 188.3  (183.6)
[1]
Measure Description: Total B cell number in the peripheral blood. B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide. Normal B Cell Count in the peripheral blood: 107 to 698 cells/uL.
Immunoglobulin G (IgG) Level   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 22 participants 21 participants 43 participants
1044.9  (408.9) 1057.1  (589.5) 1050.8  (499.1)
[1]
Measure Description: Immunoglobulin G (IgG) is a measure of immune function. Normal values: 700 to 1600 mg/dL.
Hypogammaglobulinemia   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
2
   9.1%
4
  19.0%
6
  14.0%
[1]
Measure Description: Count of participants with hypogammaglobulinemia at baseline, defined as having a serum Immunoglobulin G (IgG) level <450 mg/dL.
Anti-Double Stranded DNA (Anti-dsDNA) Positive   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
20
  90.9%
19
  90.5%
39
  90.7%
[1]
Measure Description: Count of participants who were anti-double stranded DNA (anti-dsDNA) positive at baseline, defined as anti-dsDNA levels >30 IU/mL. Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity.
Hypocomplementemic for C3   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
18
  81.8%
16
  76.2%
34
  79.1%
[1]
Measure Description: Count of participants who were hypocomplementemic for C3, defined as a C3 level <90 mg/dL. Serum C3 complement is a protein which can be measured in the blood, and low blood levels of C3 are common in those with active lupus.
Hypocomplementemic for C4   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
10
  45.5%
8
  38.1%
18
  41.9%
[1]
Measure Description: Count of participants who were hypocomplementemic for C4, defined as C4 level <10 mg/dL. Serum C4 complement is a protein which can be measured in the blood, and low blood levels of C4 are common in those with active lupus.
1.Primary Outcome
Title Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event
Hide Description The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE, version 4.03). Treatment-emergent AEs are those with an onset date on or after the first dose of study medication, those with onset before first dose but that worsened in severity after first dose, and those for which the start of the AE in relation to the start of study medication could not be established. AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were deemed “infectious” based on the study team’s review of the MedDRA body systems and preferred terms of the AEs.
Time Frame Week 0 to 48
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab. Confidence intervals were calculated using Clopper-Pearson method.
Arm/Group Title Rituximab/Cyclophosphamide (RC) Rituximab/Cyclophosphamide/Belimumab (RCB)
Hide Arm/Group Description:
Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day.
Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone was administered at 40 mg/day for the first 2 weeks, followed by a guided steroid taper to 10 mg/day by Week 12. Prednisone was continued through to Week 96 at 10 mg/day, with the potential of a taper to a minimum of 5 mg/day. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone.
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.7
(7.8 to 45.4)
9.5
(1.2 to 30.4)
Time Frame From the time of enrollment to 30 days post-treatment discontinuation, an average of 100 weeks.
Adverse Event Reporting Description On-treatment adverse events were collected from the time of enrollment to 30 days post-treatment discontinuation. After-treatment-discontinuation adverse events were collected after 30 days post-treatment discontinuation.
 
Arm/Group Title RC Group on Treatment RCB Group on Treatment RC Group After Treatment Discontinuation RCB Group After Treatment Discontinuation
Hide Arm/Group Description Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96. Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone. Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96. After a participant was discontinued from study treatment, the participant was asked to have additional visits at week 24, 36, 48, 72, and 96, if these visits had not already occurred, for safety follow up. Participants received infusions of Solumedrol 100mg, rituximab 1000mg, and cyclophosphamide 750mg intravenously (IV) at Week 0 and Week 2. Prednisone 40 mg per day was administered for the first 2 weeks, with a guided steroid taper to 10mg per day by Week 12 and continued treatment until Week 96. In addition, participants received IV belimumab 10mg/kg at Weeks 4, 6, 8, and then every 4 weeks through Week 48 in addition to prednisone. After a participant was discontinued from study treatment, the participant was asked to have additional visits at week 24, 36, 48, 72, and 96, if these visits had not already occurred, for safety follow up.
All-Cause Mortality
RC Group on Treatment RCB Group on Treatment RC Group After Treatment Discontinuation RCB Group After Treatment Discontinuation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/21 (0.00%)      0/22 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
RC Group on Treatment RCB Group on Treatment RC Group After Treatment Discontinuation RCB Group After Treatment Discontinuation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/22 (27.27%)      4/21 (19.05%)      6/22 (27.27%)      1/21 (4.76%)    
Blood and lymphatic system disorders         
Anaemia  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
Cardiac disorders         
Atrial fibrillation  1  0/22 (0.00%)  0 0/21 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0
Immune system disorders         
Serum sickness  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Infections and infestations         
Abscess soft tissue  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Cellulitis  1  0/22 (0.00%)  0 0/21 (0.00%)  0 1/22 (4.55%)  1 1/21 (4.76%)  2
Infective myositis  1  0/22 (0.00%)  0 0/21 (0.00%)  0 0/22 (0.00%)  0 1/21 (4.76%)  1
Pneumonia  1  2/22 (9.09%)  2 0/21 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0
Urinary tract infection  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Injury, poisoning and procedural complications         
Tendon rupture  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Investigations         
Blood creatinine increased  1  0/22 (0.00%)  0 0/21 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0
Metabolism and nutrition disorders         
Hypocalcaemia  1  0/22 (0.00%)  0 0/21 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  0/22 (0.00%)  0 0/21 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0
Systemic lupus erythematosus  1  2/22 (9.09%)  2 0/21 (0.00%)  0 2/22 (9.09%)  3 0/21 (0.00%)  0
Renal and urinary disorders         
Lupus nephritis  1  1/22 (4.55%)  1 1/21 (4.76%)  1 1/22 (4.55%)  1 0/21 (0.00%)  0
Renal failure  1  0/22 (0.00%)  0 0/21 (0.00%)  0 2/22 (9.09%)  2 0/21 (0.00%)  0
Vascular disorders         
Axillary vein thrombosis  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
Subclavian vein thrombosis  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
1
Term from vocabulary, 17.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RC Group on Treatment RCB Group on Treatment RC Group After Treatment Discontinuation RCB Group After Treatment Discontinuation
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/22 (100.00%)      21/21 (100.00%)      10/22 (45.45%)      6/21 (28.57%)    
Blood and lymphatic system disorders         
Anaemia  1  10/22 (45.45%)  17 13/21 (61.90%)  20 3/22 (13.64%)  3 1/21 (4.76%)  1
Leukopenia  1  5/22 (22.73%)  10 5/21 (23.81%)  9 2/22 (9.09%)  2 0/21 (0.00%)  0
Lymphopenia  1  17/22 (77.27%)  33 11/21 (52.38%)  20 8/22 (36.36%)  9 2/21 (9.52%)  3
Neutropenia  1  3/22 (13.64%)  5 5/21 (23.81%)  8 1/22 (4.55%)  1 0/21 (0.00%)  0
Endocrine disorders         
Cushingoid  1  2/22 (9.09%)  2 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea  1  2/22 (9.09%)  2 2/21 (9.52%)  3 1/22 (4.55%)  1 1/21 (4.76%)  1
Dyspepsia  1  2/22 (9.09%)  2 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Nausea  1  6/22 (27.27%)  7 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Vomiting  1  0/22 (0.00%)  0 2/21 (9.52%)  3 0/22 (0.00%)  0 0/21 (0.00%)  0
General disorders         
Fatigue  1  2/22 (9.09%)  4 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Local swelling  1  0/22 (0.00%)  0 2/21 (9.52%)  2 0/22 (0.00%)  0 1/21 (4.76%)  1
Oedema peripheral  1  3/22 (13.64%)  3 1/21 (4.76%)  1 1/22 (4.55%)  1 0/21 (0.00%)  0
Immune system disorders         
Hypogammaglobulinaemia  1  9/22 (40.91%)  12 11/21 (52.38%)  16 2/22 (9.09%)  3 0/21 (0.00%)  0
Infections and infestations         
Herpes zoster  1  0/22 (0.00%)  0 2/21 (9.52%)  2 0/22 (0.00%)  0 0/21 (0.00%)  0
Nasopharyngitis  1  0/22 (0.00%)  0 2/21 (9.52%)  3 0/22 (0.00%)  0 1/21 (4.76%)  1
Oral candidiasis  1  2/22 (9.09%)  3 2/21 (9.52%)  3 0/22 (0.00%)  0 0/21 (0.00%)  0
Upper respiratory tract infection  1  3/22 (13.64%)  5 1/21 (4.76%)  1 0/22 (0.00%)  0 1/21 (4.76%)  1
Urinary tract infection  1  3/22 (13.64%)  6 1/21 (4.76%)  2 0/22 (0.00%)  0 0/21 (0.00%)  0
Viral upper respiratory tract infection  1  2/22 (9.09%)  2 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
Injury, poisoning and procedural complications         
Infusion related reaction  1  1/22 (4.55%)  1 2/21 (9.52%)  2 0/22 (0.00%)  0 0/21 (0.00%)  0
Maternal exposure during pregnancy  1  0/22 (0.00%)  0 3/21 (14.29%)  4 0/22 (0.00%)  0 0/21 (0.00%)  0
Investigations         
Blood creatinine increased  1  5/22 (22.73%)  8 8/21 (38.10%)  11 0/22 (0.00%)  0 2/21 (9.52%)  2
Metabolism and nutrition disorders         
Hypoalbuminaemia  1  10/22 (45.45%)  15 8/21 (38.10%)  10 2/22 (9.09%)  2 1/21 (4.76%)  2
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/22 (9.09%)  2 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Back pain  1  3/22 (13.64%)  3 1/21 (4.76%)  1 0/22 (0.00%)  0 1/21 (4.76%)  1
Psychiatric disorders         
Insomnia  1  2/22 (9.09%)  2 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
Renal and urinary disorders         
Lupus nephritis  1  3/22 (13.64%)  3 5/21 (23.81%)  5 1/22 (4.55%)  1 1/21 (4.76%)  1
Proteinuria  1  7/22 (31.82%)  7 5/21 (23.81%)  7 3/22 (13.64%)  3 1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders         
Cough  1  2/22 (9.09%)  2 2/21 (9.52%)  2 0/22 (0.00%)  0 0/21 (0.00%)  0
Dyspnoea  1  2/22 (9.09%)  2 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders         
Alopecia  1  2/22 (9.09%)  2 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
Vascular disorders         
Hypertension  1  2/22 (9.09%)  2 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
1
Term from vocabulary, 17.0
Indicates events were collected by systematic assessment
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 Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02260934     History of Changes
Other Study ID Numbers: DAIT ITN055AI
CALIBRATE ( Other Identifier: Immune Tolerance Network )
First Submitted: October 6, 2014
First Posted: October 9, 2014
Results First Submitted: March 13, 2019
Results First Posted: April 8, 2019
Last Update Posted: April 8, 2019