ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 21 for:    Sjogren's Syndrome | NIH
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 : March 23, 2016
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Baminercept 100 mg   Placebo
STARTED   33   19 
COMPLETED   28   18 
NOT COMPLETED   5   1 
Withdrawal by Subject                4                0 
Physician Decision                1                0 
Subject moved away                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Baminercept 100 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   19   52 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.4  (10.9)   54.7  (11.0)   52.0  (11.0) 
Gender 
[Units: Participants]
     
Female   31   18   49 
Male   2   1   3 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   3   2   5 
Not Hispanic or Latino   29   17   46 
Unknown or Not Reported   1   0   1 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   1   0   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   3   3   6 
White   28   16   44 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   33   19   52 
Body Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 75.5  (20.4)   79.2  (19.3)   76.9  (19.9) 
[1] Body weight at the baseline visit. Weight of 40 kg or greater was required to enter the study.
Height [1] 
[Units: Cm]
Mean (Standard Deviation)
 164.4  (7.1)   163.2  (7.7)   164.0  (7.3) 
[1] 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] 
[Units: mL/min]
Mean (Standard Deviation)
 0.4  (0.5)   0.5  (0.3)   0.5  (0.4) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.7  (2.8)   3.8  (4.2)   3.1  (3.4) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.1  (2.0)   5.0  (7.5)   2.5  (5.1) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.1  (0.5)   0.2  (0.7)   0.2  (0.6) 
[1] 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] 
[Units: Mm]
Mean (Standard Deviation)
 48.6  (20.6)   50.3  (20.5)   49.2  (20.4) 
[1] 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] 
[Units: Mm]
Mean (Standard Deviation)
 70.3  (16.5)   73.5  (16.4)   71.5  (16.4) 
[1] 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.


  Outcome Measures

1.  Primary:   Change From Screening in Stimulated Whole Salivary Flow at Week 24   [ Time Frame: Screening to Week 24 ]

2.  Secondary:   Change From Screening in Stimulated Whole Salivary Flow at Week 48   [ Time Frame: Screening to Week 48 ]

3.  Secondary:   Change From Screening in Unstimulated Whole Salivary Flow at Week 24   [ Time Frame: Screening to Week 24 ]

4.  Secondary:   Change From Screening in Unstimulated Whole Salivary Flow at Week 48   [ Time Frame: Screening to Week 48 ]

5.  Secondary:   Change From Baseline in European League Against Rheumatism (EULAR) Sjogren’s Syndrome Disease Activity Index (ESSDAI) at Week 24   [ Time Frame: Baseline to Week 24 ]

6.  Secondary:   Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24   [ Time Frame: Week 24 ]

7.  Secondary:   Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48   [ Time Frame: Week 48 ]

8.  Secondary:   Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24   [ Time Frame: Week 24 ]

9.  Secondary:   Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48   [ Time Frame: Week 48 ]

10.  Secondary:   Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24   [ Time Frame: Week 24 ]

11.  Secondary:   Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48   [ Time Frame: Week 48 ]

12.  Secondary:   Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24   [ Time Frame: Week 24 ]

13.  Secondary:   Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48   [ Time Frame: Week 48 ]

14.  Secondary:   Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24   [ Time Frame: Week 24 ]

15.  Secondary:   Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48   [ Time Frame: Week 48 ]

16.  Secondary:   Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24   [ Time Frame: Week 24 ]

17.  Secondary:   Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48   [ Time Frame: Week 48 ]

18.  Secondary:   Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24   [ Time Frame: Week 24 ]

19.  Secondary:   Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48   [ Time Frame: Week 48 ]

20.  Secondary:   Percent of Participants With Adverse Events of Grade 3 or Higher   [ 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. ]

21.  Secondary:   Percent of Participants With Grade 3 or Higher Infection Adverse Event   [ 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. ]

22.  Secondary:   Percent of Participants With Injection Site Reaction or Any Grade 2 or Higher Adverse Event Within 24 Hours of Injection   [ 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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Randomization was prematurely stopped in July 2014 due to study product expiration. 52 of the 72 planned subjects were randomized.


  More Information

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
e-mail: DAITClinicalTrialsGov@niaid.nih.gov



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: March 23, 2016