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Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome

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ClinicalTrials.gov Identifier: NCT01552681
Recruitment Status : Terminated (Expired experimental study agent, no additional supply available.)
First Posted : March 13, 2012
Results First Posted : March 23, 2016
Last Update Posted : October 1, 2018
Sponsor:
Collaborators:
Autoimmunity Centers of Excellence
Biogen
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Primary Sjögren's Syndrome
Interventions Biological: Baminercept
Other: Placebo
Enrollment 52
Recruitment Details Participants were recruited from nine sites in the United States. The first site was activated in July 2012 and the last participant was randomized on 22 July 2014.
Pre-assignment Details  
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks. Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Period Title: Overall Study
Started 33 19
Completed 28 18
Not Completed 5 1
Reason Not Completed
Withdrawal by Subject             4             0
Physician Decision             1             0
Subject moved away             0             1
Arm/Group Title Baminercept 100 mg Placebo Total
Hide Arm/Group Description Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks. Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 33 19 52
Hide Baseline Analysis Population Description
The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either baminercept or placebo and had a screening stimulated salivary flow assessment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 19 participants 52 participants
50.4  (10.9) 54.7  (11.0) 52.0  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 19 participants 52 participants
Female
31
  93.9%
18
  94.7%
49
  94.2%
Male
2
   6.1%
1
   5.3%
3
   5.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 19 participants 52 participants
Hispanic or Latino
3
   9.1%
2
  10.5%
5
   9.6%
Not Hispanic or Latino
29
  87.9%
17
  89.5%
46
  88.5%
Unknown or Not Reported
1
   3.0%
0
   0.0%
1
   1.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 19 participants 52 participants
American Indian or Alaska Native
1
   3.0%
0
   0.0%
1
   1.9%
Asian
1
   3.0%
0
   0.0%
1
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   9.1%
3
  15.8%
6
  11.5%
White
28
  84.8%
16
  84.2%
44
  84.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 19 participants 52 participants
33 19 52
Body Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 33 participants 19 participants 52 participants
75.5  (20.4) 79.2  (19.3) 76.9  (19.9)
[1]
Measure Description: Body weight at the baseline visit. Weight of 40 kg or greater was required to enter the study.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 33 participants 19 participants 52 participants
164.4  (7.1) 163.2  (7.7) 164.0  (7.3)
[1]
Measure Description: Height at the baseline visit. Data were not available for six participants who received baminercept and four participants who received placebo.
Stimulated Salivary Flow Rate   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 33 participants 19 participants 52 participants
0.4  (0.5) 0.5  (0.3) 0.5  (0.4)
[1]
Measure Description: After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). A stimulated salivary flow rate of ≥ 0.1 mL/min (min) was required to enter the study.
European League Against Rheumatism (EULAR) Sjogren’s Syndrome Disease Activity Index (ESSDAI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 19 participants 52 participants
2.7  (2.8) 3.8  (4.2) 3.1  (3.4)
[1]
Measure Description: The ESSDAI is a clinical index that measures Sjogren’s syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity.
Tender Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 19 participants 52 participants
1.1  (2.0) 5.0  (7.5) 2.5  (5.1)
[1]
Measure Description: Tender Joint Count (TJC) is the number of tender joints based on the tenderness response of 28 joints examined. TJC possible values range from 0 to 28.
Swollen Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 19 participants 52 participants
0.1  (0.5) 0.2  (0.7) 0.2  (0.6)
[1]
Measure Description: Swollen Joint Count (SJC) is the number of swollen joints based on swelling response of 28 joints examined. SJC possible values range from 0 to 28.
Physician's Global Assessment of Disease Activity   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 33 participants 19 participants 52 participants
48.6  (20.6) 50.3  (20.5) 49.2  (20.4)
[1]
Measure Description: The physician’s response to the question “Overall, how would you rate the Sjogren’s Syndrome symptom activity of the subject?” A vertical mark on a 100 mm horizontal line rated 0 (Not active) to 100 (Very active). The range: 0 to 100, with 100 indicating severe symptoms.
Patient's Global Assessment of Disease Activity   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 33 participants 19 participants 52 participants
70.3  (16.5) 73.5  (16.4) 71.5  (16.4)
[1]
Measure Description: A self-reported measure of perceived disease activity obtained by responding to the question "Overall, how would you rate your Sjogren's Syndrome symptom activity?" A vertical mark on a 100 mm line rated 0 (Not active) to 100 (Very active) determines the score. The range: 0 to 100, with 100 indicating severe symptoms.
1.Primary Outcome
Title Change From Screening in Stimulated Whole Salivary Flow at Week 24
Hide Description After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Time Frame Screening to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either baminercept or placebo with screening and post-screening stimulated salivary flow results. Participants missing Week 24 assessment were imputed from last post-screening assessment. Salivary flow results unavailable for one subject.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 32 19
Mean (Standard Deviation)
Unit of Measure: mL/min
0.0  (0.3) 0.1  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baminercept 100 mg, Placebo
Comments Missing Week 24 assessments were imputed by carrying forward the last observed post-baseline value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments P-value is testing for treatment effect using an analysis of covariance with adjustments for screening stimulated salivary flow.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change From Screening in Stimulated Whole Salivary Flow at Week 48
Hide Description After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Time Frame Screening to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat with available data population included all randomized subjects who received >=1 dose of either baminercept or placebo and who had stimulated salivary flow results at screening and Week 48. Wk 48 stimulated salivary flow results were not available for N=7 subjects (e.g., N=6 in baminercept and N=1 in placebo group).
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 27 18
Mean (Standard Deviation)
Unit of Measure: mL/min
0.0  (0.3) -0.1  (0.2)
3.Secondary Outcome
Title Change From Screening in Unstimulated Whole Salivary Flow at Week 24
Hide Description The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Time Frame Screening to Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Modified Intent-to-Treat with available data population included all randomized subjects who received >=1 dose of either baminercept or placebo and who had an unstimulated salivary flow assessment at screening and week 24. Data were not available for N=7 subjects (e.g., N=5 in baminercept and N=2 in placebo group).
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 28 17
Mean (Standard Deviation)
Unit of Measure: mL/min
0.1  (0.2) 0.1  (0.1)
4.Secondary Outcome
Title Change From Screening in Unstimulated Whole Salivary Flow at Week 48
Hide Description The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.
Time Frame Screening to Week 48
Show Outcome Measure DataHide 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 baminercept or placebo and who had unstimulated salivary flow results at Screening and Week 48. Data were not available for six participants who received baminercept and one participant who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 27 18
Mean (Standard Deviation)
Unit of Measure: mL/min
0.1  (0.1) 0.1  (0.1)
5.Secondary Outcome
Title Change From Baseline in European League Against Rheumatism (EULAR) Sjogren’s Syndrome Disease Activity Index (ESSDAI) at Week 24
Hide Description The ESSDAI is a clinical index that measures Sjogren’s syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Time Frame Baseline to Week 24
Show Outcome Measure DataHide 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 baminercept or placebo and who had an ESSDAI score at Baseline and Week 24. Data were not available for five participants who received baminercept and two participants who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 28 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.1  (2.3) -0.4  (3.1)
6.Secondary Outcome
Title Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24
Hide Description Response is defined by 30% or more improvement (decrease) from baseline to week 24 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.
Time Frame Week 24
Show Outcome Measure DataHide 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 baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and one participant who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 29 18
Measure Type: Number
Unit of Measure: Percent of participants
20.7 22.2
7.Secondary Outcome
Title Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48
Hide Description Response is defined by 30% or more improvement (decrease) from baseline to week 48 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.
Time Frame Week 48
Show Outcome Measure DataHide 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 baminercept or placebo and who had VAS results at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 28 18
Measure Type: Number
Unit of Measure: Percent of participants
21.4 5.6
8.Secondary Outcome
Title Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24
Hide Description On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Time Frame Week 24
Show Outcome Measure DataHide 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 baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 29 17
Mean (Standard Deviation)
Unit of Measure: mm
Difficulty speaking due to dryness -0.7  (29.1) -9.2  (18.6)
Difficulty swallowing due to dryness -6.5  (23.6) -10.1  (20.5)
Dryness of mouth -11.4  (27.2) -12.7  (23.1)
Dryness of throat -4.9  (26.2) -7.9  (25.7)
Dryness of lips -9.4  (24.7) -10.8  (27.7)
Dryness of tongue -7.8  (25.5) -8.9  (25.9)
Thirst -9.2  (29.4) -11.9  (22.3)
Oral discomfort in mouth -4.4  (30.3) -8.9  (23.0)
Facial swelling 0.3  (22.6) 4.9  (18.1)
Dry eye sensation -1.6  (30.1) -10.4  (25.0)
Severity of sandy/gritty eye -0.5  (37.4) -7.3  (24.8)
Blurry vision -1.5  (35.6) -7.6  (26.6)
Sensitivity to bright lights -6.6  (29.0) -9.3  (16.4)
Ease with which eyes feel tired -7.6  (30.1) -6.6  (16.9)
9.Secondary Outcome
Title Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48
Hide Description On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Time Frame Week 48
Show Outcome Measure DataHide 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 baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 28 18
Mean (Standard Deviation)
Unit of Measure: mm
Difficulty speaking due to dryness -2.6  (33.4) -2.8  (22.4)
Difficulty swallowing due to dryness -7.4  (24.8) -1.3  (23.4)
Dryness of mouth -11.0  (24.1) -6.6  (17.9)
Dryness of throat -4.0  (25.8) -1.5  (20.9)
Dryness of lips -8.0  (21.3) -3.4  (24.9)
Dryness of tongue -4.2  (22.2) 1.3  (26.4)
Thirst -11.6  (25.8) -5.8  (20.1)
Oral discomfort in mouth -9.6  (24.7) 2.8  (22.4)
Facial swelling -3.7  (18.4) 8.5  (24.4)
Dry eye sensation 0.5  (28.9) -2.2  (21.2)
Severity of sandy/gritty eye 1.6  (39.2) 4.3  (18.4)
Blurry vision -11.2  (35.8) 5.1  (27.5)
Sensitivity to bright lights -10.2  (23.8) -0.9  (22.5)
Ease with which eyes feel tired -11.3  (24.4) -1.0  (22.7)
10.Secondary Outcome
Title Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24
Hide Description Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Time Frame Week 24
Show Outcome Measure DataHide 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 baminercept or placebo and who had VAS scores at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 29 17
Mean (Standard Deviation)
Unit of Measure: mm
Overall dryness -8.3  (25.8) -9.8  (21.6)
Overall fatigue -9.1  (26.9) -9.3  (26.7)
Degree of joint pain -4.9  (25.6) -8.7  (25.9)
11.Secondary Outcome
Title Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48
Hide Description Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Time Frame Week 48
Show Outcome Measure DataHide 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 baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 28 18
Mean (Standard Deviation)
Unit of Measure: mm
Overall dryness -10.8  (26.8) -1.6  (17.5)
Overall fatigue -6.3  (23.5) -7.1  (30.8)
Degree of joint pain -3.9  (30.2) -2.3  (24.0)
12.Secondary Outcome
Title Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24
Hide Description A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Time Frame Week 24
Show Outcome Measure DataHide 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 baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 24. Data were not available for six participants
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 29 17
Mean (Standard Deviation)
Unit of Measure: mm
Patient Global Assessment of Disease Activity -14.0  (29.5) -9.6  (19.1)
Global Assessment of Disease Activity -16.4  (16.6) -13.3  (20.1)
13.Secondary Outcome
Title Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48
Hide Description A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Time Frame Week 48
Show Outcome Measure DataHide 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 baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 48. Data were not available for six participants
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 28 18
Mean (Standard Deviation)
Unit of Measure: mm
Patient Global Assessment of Disease Activity -9.3  (23.9) -4.3  (22.0)
Global Assessment of Disease Activity -10.1  (22.7) -8.4  (19.9)
14.Secondary Outcome
Title Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24
Hide Description A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.
Time Frame Week 24
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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 baminercept or placebo and who had Schirmer's I test data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: mm/5 min
Left Eye 0.8  (8.0) 1.9  (11.1)
Right Eye 1.3  (5.6) -4.3  (8.5)
15.Secondary Outcome
Title Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48
Hide Description A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.
Time Frame Week 48
Show Outcome Measure DataHide 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 baminercept or placebo and who had Schirmer's I test data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 25 18
Mean (Standard Deviation)
Unit of Measure: mm/5 min
Left Eye -0.8  (8.7) 3.6  (11.2)
Right Eye 2.2  (7.4) 0.2  (9.4)
16.Secondary Outcome
Title Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24
Hide Description Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.
Time Frame Week 24
Show Outcome Measure DataHide 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 baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 27 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.7  (9.2) -0.4  (6.3)
17.Secondary Outcome
Title Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48
Hide Description Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.
Time Frame Week 48
Show Outcome Measure DataHide 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 baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 25 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.1  (10.8) 0.1  (9.3)
18.Secondary Outcome
Title Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24
Hide Description The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.
Time Frame Week 24
Show Outcome Measure DataHide 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 baminercept or placebo and who had SF-36 data at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 29 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall Physical Score 2.7  (6.4) -1.0  (9.3)
Overall Mental Score -1.2  (13.0) -0.3  (10.3)
19.Secondary Outcome
Title Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48
Hide Description The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.
Time Frame Week 48
Show Outcome Measure DataHide 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 baminercept or placebo and who had SF-36 data at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 28 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall Physical Score 1.4  (6.5) 1.5  (7.1)
Overall Mental Score -1.2  (15.2) -0.2  (8.3)
20.Secondary Outcome
Title Percent of Participants With Adverse Events of Grade 3 or Higher
Hide Description Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.
Time Frame From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.
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Hide Analysis Population Description
The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 33 19
Measure Type: Number
Unit of Measure: Percent of participants
27.3 15.8
21.Secondary Outcome
Title Percent of Participants With Grade 3 or Higher Infection Adverse Event
Hide Description Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher infection adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.
Time Frame From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 33 19
Measure Type: Number
Unit of Measure: Percent of participants
6.1 0
22.Secondary Outcome
Title Percent of Participants With Injection Site Reaction or Any Grade 2 or Higher Adverse Event Within 24 Hours of Injection
Hide Description Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one injection site reaction or Grade 2 or higher adverse event within 24 hours of injection are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.
Time Frame From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description:
Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Number of Participants Analyzed 33 19
Measure Type: Number
Unit of Measure: Percent of participants
81.8 57.9
Time Frame From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.
Adverse Event Reporting Description This study graded the severity of adverse events experienced by the study participant according to criteria set forth by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (May 28, 2009)
 
Arm/Group Title Baminercept 100 mg Placebo
Hide Arm/Group Description Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks. Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
All-Cause Mortality
Baminercept 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Baminercept 100 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/33 (15.15%)      1/19 (5.26%)    
Hepatobiliary disorders     
Hepatocellular injury  1  1/33 (3.03%)  1 0/19 (0.00%)  0
Infections and infestations     
Pleurisy viral  1  1/33 (3.03%)  1 0/19 (0.00%)  0
Investigations     
Liver function test abnormal  1  1/33 (3.03%)  1 0/19 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/33 (3.03%)  1 0/19 (0.00%)  0
Nervous system disorders     
Syncope  1  1/33 (3.03%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/33 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baminercept 100 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/33 (100.00%)      18/19 (94.74%)    
Blood and lymphatic system disorders     
Anaemia  1  8/33 (24.24%)  17 3/19 (15.79%)  3
Leukopenia  1  3/33 (9.09%)  3 2/19 (10.53%)  3
Lymphopenia  1  8/33 (24.24%)  11 4/19 (21.05%)  7
Neutropenia  1  4/33 (12.12%)  7 5/19 (26.32%)  7
Thrombocytopenia  1  2/33 (6.06%)  2 1/19 (5.26%)  1
Gastrointestinal disorders     
Diarrhoea  1  4/33 (12.12%)  4 3/19 (15.79%)  4
Nausea  1  4/33 (12.12%)  5 3/19 (15.79%)  4
Vomiting  1  3/33 (9.09%)  3 1/19 (5.26%)  1
General disorders     
Fatigue  1  2/33 (6.06%)  9 3/19 (15.79%)  4
Injection site haematoma  1  3/33 (9.09%)  3 2/19 (10.53%)  2
Injection site reaction  1  17/33 (51.52%)  42 6/19 (31.58%)  22
Non-cardiac chest pain  1  2/33 (6.06%)  2 1/19 (5.26%)  1
Pyrexia  1  2/33 (6.06%)  2 1/19 (5.26%)  1
Vaccination site reaction  1  4/33 (12.12%)  4 3/19 (15.79%)  3
Hepatobiliary disorders     
Hepatobiliary disease  1  2/33 (6.06%)  2 1/19 (5.26%)  1
Immune system disorders     
Type IV hypersensitivity reaction  1  3/33 (9.09%)  3 2/19 (10.53%)  2
Infections and infestations     
Bronchitis  1  2/33 (6.06%)  2 1/19 (5.26%)  1
Tooth infection  1  3/33 (9.09%)  3 1/19 (5.26%)  1
Upper respiratory tract infection  1  8/33 (24.24%)  8 3/19 (15.79%)  3
Urinary tract infection  1  4/33 (12.12%)  7 3/19 (15.79%)  3
Injury, poisoning and procedural complications     
Foot fracture  1  4/33 (12.12%)  4 0/19 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  4/33 (12.12%)  4 1/19 (5.26%)  1
Aspartate aminotransferase increased  1  4/33 (12.12%)  5 2/19 (10.53%)  3
Blood creatinine increased  1  12/33 (36.36%)  21 9/19 (47.37%)  13
Weight decreased  1  6/33 (18.18%)  6 0/19 (0.00%)  0
Weight increased  1  4/33 (12.12%)  4 2/19 (10.53%)  2
Metabolism and nutrition disorders     
Hypercalcaemia  1  6/33 (18.18%)  7 5/19 (26.32%)  8
Hypercholesterolaemia  1  9/33 (27.27%)  9 4/19 (21.05%)  6
Hyperglycaemia  1  2/33 (6.06%)  3 1/19 (5.26%)  1
Hypertriglyceridaemia  1  2/33 (6.06%)  2 6/19 (31.58%)  6
Hypoglycaemia  1  7/33 (21.21%)  10 3/19 (15.79%)  6
Hypokalaemia  1  4/33 (12.12%)  5 2/19 (10.53%)  3
Hyponatraemia  1  1/33 (3.03%)  3 3/19 (15.79%)  5
Hypophosphataemia  1  2/33 (6.06%)  2 1/19 (5.26%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/33 (6.06%)  2 1/19 (5.26%)  1
Bursitis  1  2/33 (6.06%)  2 1/19 (5.26%)  1
Nervous system disorders     
Headache  1  9/33 (27.27%)  22 4/19 (21.05%)  5
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1  2/33 (6.06%)  3 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Randomization was prematurely stopped in July 2014 due to study product expiration. 52 of the 72 planned subjects were randomized.
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: NCT01552681     History of Changes
Other Study ID Numbers: DAIT ASJ02
First Submitted: March 9, 2012
First Posted: March 13, 2012
Results First Submitted: February 21, 2016
Results First Posted: March 23, 2016
Last Update Posted: October 1, 2018