Trial Outcomes & Findings for Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome (NCT NCT01552681)

Last Updated: 2019-01-14

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Screening to Week 24

Results posted on

2019-01-14

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Baminercept 100 mg Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Study STARTED	33	19
Overall Study COMPLETED	28	18
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Baminercept 100 mg Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Overall Study Withdrawal by Subject	4	0
Overall Study Physician Decision	1	0
Overall Study Subject moved away	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baminercept 100 mg n=33 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=19 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.	Total n=52 Participants Total of all reporting groups
Age, Continuous	50.4 years STANDARD_DEVIATION 10.9 • n=93 Participants	54.7 years STANDARD_DEVIATION 11.0 • n=4 Participants	52.0 years STANDARD_DEVIATION 11.0 • n=27 Participants
Sex: Female, Male Female	31 Participants n=93 Participants	18 Participants n=4 Participants	49 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=93 Participants	17 Participants n=4 Participants	46 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants	16 Participants n=4 Participants	44 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	33 participants n=93 Participants	19 participants n=4 Participants	52 participants n=27 Participants
Body Weight	75.5 kg STANDARD_DEVIATION 20.4 • n=93 Participants	79.2 kg STANDARD_DEVIATION 19.3 • n=4 Participants	76.9 kg STANDARD_DEVIATION 19.9 • n=27 Participants
Height	164.4 cm STANDARD_DEVIATION 7.1 • n=93 Participants	163.2 cm STANDARD_DEVIATION 7.7 • n=4 Participants	164.0 cm STANDARD_DEVIATION 7.3 • n=27 Participants
Stimulated Salivary Flow Rate	0.4 mL/min STANDARD_DEVIATION 0.5 • n=93 Participants	0.5 mL/min STANDARD_DEVIATION 0.3 • n=4 Participants	0.5 mL/min STANDARD_DEVIATION 0.4 • n=27 Participants
European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score	2.7 units on a scale STANDARD_DEVIATION 2.8 • n=93 Participants	3.8 units on a scale STANDARD_DEVIATION 4.2 • n=4 Participants	3.1 units on a scale STANDARD_DEVIATION 3.4 • n=27 Participants
Tender Joint Count	1.1 units on a scale STANDARD_DEVIATION 2.0 • n=93 Participants	5.0 units on a scale STANDARD_DEVIATION 7.5 • n=4 Participants	2.5 units on a scale STANDARD_DEVIATION 5.1 • n=27 Participants
Swollen Joint Count	0.1 units on a scale STANDARD_DEVIATION 0.5 • n=93 Participants	0.2 units on a scale STANDARD_DEVIATION 0.7 • n=4 Participants	0.2 units on a scale STANDARD_DEVIATION 0.6 • n=27 Participants
Physician's Global Assessment of Disease Activity	48.6 mm STANDARD_DEVIATION 20.6 • n=93 Participants	50.3 mm STANDARD_DEVIATION 20.5 • n=4 Participants	49.2 mm STANDARD_DEVIATION 20.4 • n=27 Participants
Patient's Global Assessment of Disease Activity	70.3 mm STANDARD_DEVIATION 16.5 • n=93 Participants	73.5 mm STANDARD_DEVIATION 16.4 • n=4 Participants	71.5 mm STANDARD_DEVIATION 16.4 • n=27 Participants

PRIMARY outcome

Timeframe: Screening to Week 24

Population: 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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=32 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=19 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Screening in Stimulated Whole Salivary Flow at Week 24	0.0 mL/min Standard Deviation 0.3	0.1 mL/min Standard Deviation 0.2

SECONDARY outcome

Timeframe: Screening to Week 48

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=27 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=18 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Screening in Stimulated Whole Salivary Flow at Week 48	0.0 mL/min Standard Deviation 0.3	-0.1 mL/min Standard Deviation 0.2

SECONDARY outcome

Timeframe: Screening to Week 24

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=28 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=17 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Screening in Unstimulated Whole Salivary Flow at Week 24	0.1 mL/min Standard Deviation 0.2	0.1 mL/min Standard Deviation 0.1

SECONDARY outcome

Timeframe: Screening to Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=27 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=18 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Screening in Unstimulated Whole Salivary Flow at Week 48	0.1 mL/min Standard Deviation 0.1	0.1 mL/min Standard Deviation 0.1

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=28 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=17 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24	-1.1 units on a scale Standard Deviation 2.3	-0.4 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=29 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=18 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24	20.7 Percent of participants	22.2 Percent of participants

SECONDARY outcome

Timeframe: Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=28 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=18 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48	21.4 Percent of participants	5.6 Percent of participants

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=29 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=17 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Difficulty speaking due to dryness	-0.7 mm Standard Deviation 29.1	-9.2 mm Standard Deviation 18.6
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Difficulty swallowing due to dryness	-6.5 mm Standard Deviation 23.6	-10.1 mm Standard Deviation 20.5
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Dryness of mouth	-11.4 mm Standard Deviation 27.2	-12.7 mm Standard Deviation 23.1
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Dryness of throat	-4.9 mm Standard Deviation 26.2	-7.9 mm Standard Deviation 25.7
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Dryness of lips	-9.4 mm Standard Deviation 24.7	-10.8 mm Standard Deviation 27.7
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Dryness of tongue	-7.8 mm Standard Deviation 25.5	-8.9 mm Standard Deviation 25.9
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Thirst	-9.2 mm Standard Deviation 29.4	-11.9 mm Standard Deviation 22.3
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Oral discomfort in mouth	-4.4 mm Standard Deviation 30.3	-8.9 mm Standard Deviation 23.0
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Facial swelling	0.3 mm Standard Deviation 22.6	4.9 mm Standard Deviation 18.1
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Dry eye sensation	-1.6 mm Standard Deviation 30.1	-10.4 mm Standard Deviation 25.0
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Severity of sandy/gritty eye	-0.5 mm Standard Deviation 37.4	-7.3 mm Standard Deviation 24.8
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Blurry vision	-1.5 mm Standard Deviation 35.6	-7.6 mm Standard Deviation 26.6
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Sensitivity to bright lights	-6.6 mm Standard Deviation 29.0	-9.3 mm Standard Deviation 16.4
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24 Ease with which eyes feel tired	-7.6 mm Standard Deviation 30.1	-6.6 mm Standard Deviation 16.9

SECONDARY outcome

Timeframe: Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=28 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=18 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Difficulty speaking due to dryness	-2.6 mm Standard Deviation 33.4	-2.8 mm Standard Deviation 22.4
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Difficulty swallowing due to dryness	-7.4 mm Standard Deviation 24.8	-1.3 mm Standard Deviation 23.4
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Dryness of mouth	-11.0 mm Standard Deviation 24.1	-6.6 mm Standard Deviation 17.9
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Dryness of throat	-4.0 mm Standard Deviation 25.8	-1.5 mm Standard Deviation 20.9
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Dryness of lips	-8.0 mm Standard Deviation 21.3	-3.4 mm Standard Deviation 24.9
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Dryness of tongue	-4.2 mm Standard Deviation 22.2	1.3 mm Standard Deviation 26.4
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Thirst	-11.6 mm Standard Deviation 25.8	-5.8 mm Standard Deviation 20.1
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Oral discomfort in mouth	-9.6 mm Standard Deviation 24.7	2.8 mm Standard Deviation 22.4
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Facial swelling	-3.7 mm Standard Deviation 18.4	8.5 mm Standard Deviation 24.4
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Dry eye sensation	0.5 mm Standard Deviation 28.9	-2.2 mm Standard Deviation 21.2
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Severity of sandy/gritty eye	1.6 mm Standard Deviation 39.2	4.3 mm Standard Deviation 18.4
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Blurry vision	-11.2 mm Standard Deviation 35.8	5.1 mm Standard Deviation 27.5
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Sensitivity to bright lights	-10.2 mm Standard Deviation 23.8	-0.9 mm Standard Deviation 22.5
Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48 Ease with which eyes feel tired	-11.3 mm Standard Deviation 24.4	-1.0 mm Standard Deviation 22.7

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=29 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=17 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24 Overall dryness	-8.3 mm Standard Deviation 25.8	-9.8 mm Standard Deviation 21.6
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24 Overall fatigue	-9.1 mm Standard Deviation 26.9	-9.3 mm Standard Deviation 26.7
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24 Degree of joint pain	-4.9 mm Standard Deviation 25.6	-8.7 mm Standard Deviation 25.9

SECONDARY outcome

Timeframe: Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=28 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=18 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48 Overall dryness	-10.8 mm Standard Deviation 26.8	-1.6 mm Standard Deviation 17.5
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48 Overall fatigue	-6.3 mm Standard Deviation 23.5	-7.1 mm Standard Deviation 30.8
Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48 Degree of joint pain	-3.9 mm Standard Deviation 30.2	-2.3 mm Standard Deviation 24.0

SECONDARY outcome

Timeframe: Week 24

Population: 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

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=29 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=17 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24 Patient Global Assessment of Disease Activity	-14.0 mm Standard Deviation 29.5	-9.6 mm Standard Deviation 19.1
Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24 Global Assessment of Disease Activity	-16.4 mm Standard Deviation 16.6	-13.3 mm Standard Deviation 20.1

SECONDARY outcome

Timeframe: Week 48

Population: 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

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=28 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=18 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48 Patient Global Assessment of Disease Activity	-9.3 mm Standard Deviation 23.9	-4.3 mm Standard Deviation 22.0
Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48 Global Assessment of Disease Activity	-10.1 mm Standard Deviation 22.7	-8.4 mm Standard Deviation 19.9

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=27 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=16 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24 Left Eye	0.8 mm/5 min Standard Deviation 8.0	1.9 mm/5 min Standard Deviation 11.1
Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24 Right Eye	1.3 mm/5 min Standard Deviation 5.6	-4.3 mm/5 min Standard Deviation 8.5

SECONDARY outcome

Timeframe: Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=25 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=18 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48 Left Eye	-0.8 mm/5 min Standard Deviation 8.7	3.6 mm/5 min Standard Deviation 11.2
Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48 Right Eye	2.2 mm/5 min Standard Deviation 7.4	0.2 mm/5 min Standard Deviation 9.4

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=27 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=16 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24	-0.7 units on a scale Standard Deviation 9.2	-0.4 units on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=25 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=18 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48	1.1 units on a scale Standard Deviation 10.8	0.1 units on a scale Standard Deviation 9.3

SECONDARY outcome

Timeframe: Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=29 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=17 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24 Overall Physical Score	2.7 units on a scale Standard Deviation 6.4	-1.0 units on a scale Standard Deviation 9.3
Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24 Overall Mental Score	-1.2 units on a scale Standard Deviation 13.0	-0.3 units on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: Week 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=28 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=18 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48 Overall Physical Score	1.4 units on a scale Standard Deviation 6.5	1.5 units on a scale Standard Deviation 7.1
Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48 Overall Mental Score	-1.2 units on a scale Standard Deviation 15.2	-0.2 units on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.

Population: The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=33 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=19 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Percent of Participants With Adverse Events of Grade 3 or Higher	27.3 Percent of participants	15.8 Percent of participants

SECONDARY outcome

Timeframe: From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.

Population: The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=33 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=19 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Percent of Participants With Grade 3 or Higher Infection Adverse Event	6.1 Percent of participants	0 Percent of participants

SECONDARY outcome

Timeframe: From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.

Population: The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.

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.

Outcome measures

Outcome measures
Measure	Baminercept 100 mg n=33 Participants Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=19 Participants Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Percent of Participants With Injection Site Reaction or Any Grade 2 or Higher Adverse Event Within 24 Hours of Injection	81.8 Percent of participants	57.9 Percent of participants

Adverse Events

Baminercept 100 mg

Serious events: 5 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Baminercept 100 mg n=33 participants at risk Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.	Placebo n=19 participants at risk Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
Hepatobiliary disorders Hepatocellular injury	3.0% 1/33 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)	0.00% 0/19 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)
Infections and infestations Pleurisy viral	3.0% 1/33 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)	0.00% 0/19 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)
Investigations Liver function test abnormal	3.0% 1/33 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)	0.00% 0/19 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	3.0% 1/33 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)	0.00% 0/19 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)
Nervous system disorders Syncope	3.0% 1/33 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)	0.00% 0/19 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/33 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)	5.3% 1/19 • Number of events 1 • From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks. 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)

Other adverse events

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place