Primary Sjögren's Syndrome
Conditions
Keywords
Sjögren, Sjögren's Syndrome, Autoimmune disease, Systemic, Xerostomia, xerophthalmia, Salivary gland disease, Arthritis, Joint disease, Monoclonal antibody
Brief summary
The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.
Interventions
DRUGS95011 concentrate for solution for infusion
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
DRUGPlacebo concentrate for solution for infusion
IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
Sponsors
ADIR, a Servier Group company
Institut de Recherches Internationales Servier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of primary Sjögren's Syndrome based on 2016 American College of Rheumatology-EULAR criteria 2. ESSDAI total score ≥ 6 during screening, with at least 6 points scored within the 7 following domains: constitutional, lymphadenopathy, glandular, articular, cutaneous, hematologic and biologic, 3. Positive anti-Sjögren's Syndrome A (Ro) antibodies or anti-nuclear antibodies (ANA) ≥ 1:320 or rheumatoid factor (RF) \>20 IU/ml during screening period, measured in a central laboratory 4. Stimulated whole salivary flow rate \> 0 mL/minute
Exclusion criteria
1. Prior administration within the timeframe described in the protocol of any of the following: * Belimumab, * Rituximab or other B cell depleting agents, * Abatacept, * Tumor necrosis factor inhibitors, * Tocilizumab, * Cyclophosphamide, * Cyclosporine (except for eye drops), tacrolimus, sirolimus, mycophenolate mofetil (MMF), azathioprine, or leflunomide * Janus kinase (JAK) inhibitors 2. Meeting any of the following conditions: * Corticosteroids: \> 10 mg/day oral prednisone (or equivalent) within 4 weeks prior to randomisation (W000); Any change or initiation of new dose of oral prednisone (or equivalent) within 4 weeks prior to randomisation (W000); Intramuscular, IV, or intra-articular corticosteroids within 4 weeks prior to randomisation (W000); Any change or initiation of new dose of topical corticosteroids within 2 weeks prior to randomisation (W000), * Antimalarials: any change or initiation of new dose of antimalarials (e.g. chloroquine, hydroxychloroquine, quinacrine) within 16 weeks prior to randomisation (W000), * Methotrexate: \> 25 mg/week of methotrexate; any initiation or change of dose of methotrexate within 12 weeks prior to randomisation (W000); any change in route of administration within 4 weeks prior to randomisation (W000), * Non-steroidal anti-inflammatory drugs (NSAIDs): Any change or initiation of new dose of regularly scheduled NSAIDs within 2 weeks prior to randomisation (W000), * Cevimeline or pilocarpine and cyclosporine eye drops (Restasis) and lifitegrast: any increase or initiation of new doses within 2 weeks prior to randomisation (W000). 3. Secondary Sjögren's Syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ESSDAI Total Score | From baseline to week 13 | Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. Scores range from 0 - 123, with a lower score representing less disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ESSPRI Score by Symptom and Total Score | At baseline, week 4 and week 13 | Efficacy criterion EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is an index designed to measure patients' symptoms in primary Sjögren's Syndrome. The three domains included in this scale are dryness, fatigue, and pain, each of which are scored on a scale of 0-10. The total score is calculated as the average of the three domain scores and therefore the maximum total score is 10. The higher score represents more severe symptoms. |
| Quality of Life (SF-36) | At baseline and week 13 | Efficacy criterion The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health to asses QoL. Scores for each subscale range from 0 - 100, with a lower number representing a worse quality of life. |
| Fatigue (MFI) | At baseline and week 13 | Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate five dimensions of fatigue. Scores range from 4 to 20 for each sub-score, with a lower score representing less fatigue. |
| ESSDAI Score by Domain and Total Score | At baseline, week 4 and week 13 | Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. There are 12 organ-specific domains and for each domain, features of disease activity are scored according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The total score ranges from 0 to 123. A higher score always represents a more severe disease activity. The domain \[weight\] and score range are as follows: Constitutional \[3\] 0-2; Lymphadenopathy and lymphoma \[4\] 0-3; Glandular \[2\] 0-2; Articular \[2\] 0-3; Cutaneous \[3\] 0-3; Pulmonary \[5\] 0-3; Renal \[5\] 0-3; Muscular \[6\] 0-3; PNS \[5\] 0-3; CNS \[5\] 0-3; Hematological \[2\] 0-3; Biological \[1\] 0-2. |
| Patient's Global Assessment (PGA) of the Disease Activity | At baseline and week 13 | Efficacy criterion Patient's global assessment (PGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity. |
| Number of Participants With Adverse Events (AEs) | Through study completion, up to Week 28 | Safety criterion |
| Physician's Global Assessment (PhGA) of the Disease Activity | At baseline and week 13 | Efficacy criterion Physician's global assessment (PhGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity. |
Countries
Australia, France, Germany, Hungary, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| S95011 Concentrate for Solution for Infusion S95011 was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
S95011 concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10. | 31 |
| S95011 Placebo Concentrate for Solution for Infusion S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
Placebo concentrate for solution for infusion: IV administration every 2 weeks until week 4 and then every 3 weeks until week 10. | 17 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Withdrawal nonmedical reason | 1 | 1 |
Baseline characteristics
| Characteristic | S95011 Concentrate for Solution for Infusion | Total | S95011 Placebo Concentrate for Solution for Infusion |
|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 12.6 | 53.7 years STANDARD_DEVIATION 12.4 | 53.6 years STANDARD_DEVIATION 12.5 |
| Duration since diagnosis of pSS (years) | 7.6 years STANDARD_DEVIATION 7.7 | 7.2 years STANDARD_DEVIATION 7.3 | 6.5 years STANDARD_DEVIATION 6.6 |
| Patient taking a specific treatment for pSS (for randomization stratification) Antimalarial | 5 Participants | 10 Participants | 5 Participants |
| Patient taking a specific treatment for pSS (for randomization stratification) Nothing | 17 Participants | 25 Participants | 8 Participants |
| Patient taking a specific treatment for pSS (for randomization stratification) Oral corticosteroid | 4 Participants | 5 Participants | 1 Participants |
| Patient taking a specific treatment for pSS (for randomization stratification) Oral corticosteroid and antimalarial | 5 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 30 Participants | 46 Participants | 16 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 28 Participants | 44 Participants | 16 Participants |
| Sex: Female, Male Female | 26 Participants | 42 Participants | 16 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 17 |
| other Total, other adverse events | 24 / 31 | 11 / 17 |
| serious Total, serious adverse events | 3 / 31 | 1 / 17 |
Outcome results
Primary
Change in ESSDAI Total Score
Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. Scores range from 0 - 123, with a lower score representing less disease activity.
Time frame: From baseline to week 13
Population: Change in ESSDAI Total Score is computed only on observed values before occurrence of Intercurrent Events.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| S95011 Concentrate for Solution for Infusion | Change in ESSDAI Total Score | Change from Baseline to Week 13 | -3.77 score on a scale | Standard Deviation 4.55 |
| S95011 Concentrate for Solution for Infusion | Change in ESSDAI Total Score | Baseline | 11.52 score on a scale | Standard Deviation 3.75 |
| S95011 Concentrate for Solution for Infusion | Change in ESSDAI Total Score | Week 13 | 7.96 score on a scale | Standard Deviation 4.91 |
| S95011 Placebo Concentrate for Solution for Infusion | Change in ESSDAI Total Score | Change from Baseline to Week 13 | -5.54 score on a scale | Standard Deviation 4.89 |
| S95011 Placebo Concentrate for Solution for Infusion | Change in ESSDAI Total Score | Baseline | 13.12 score on a scale | Standard Deviation 7.2 |
| S95011 Placebo Concentrate for Solution for Infusion | Change in ESSDAI Total Score | Week 13 | 8.85 score on a scale | Standard Deviation 8.59 |
95% CI: [-0.61, 5.49]
Secondary
ESSDAI Score by Domain and Total Score
Efficacy criterion Eular Sjögren Syndrome Disease Activity index (ESSDAI) is a physician-administered clinical index which has been validated to objectively assess systemic manifestations in Primary Sjögren's Syndrome patients. There are 12 organ-specific domains and for each domain, features of disease activity are scored according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. The total score ranges from 0 to 123. A higher score always represents a more severe disease activity. The domain \[weight\] and score range are as follows: Constitutional \[3\] 0-2; Lymphadenopathy and lymphoma \[4\] 0-3; Glandular \[2\] 0-2; Articular \[2\] 0-3; Cutaneous \[3\] 0-3; Pulmonary \[5\] 0-3; Renal \[5\] 0-3; Muscular \[6\] 0-3; PNS \[5\] 0-3; CNS \[5\] 0-3; Hematological \[2\] 0-3; Biological \[1\] 0-2.
Time frame: At baseline, week 4 and week 13
Population: ESSDAI Score by Domain and Total Score is computed without consideration of Intercurrent Events, therefore data gathered after an intercurrent event is not set as missing. The participant data that is missing from Week 4 and Week 13 was not available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Total Score - Baseline | 11.5 score on a scale | Standard Deviation 3.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Total Score - Week 4 | 9.5 score on a scale | Standard Deviation 3.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Total Score - Week 13 | 7.8 score on a scale | Standard Deviation 4.8 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Constitutional - Baseline | 0.6 score on a scale | Standard Deviation 0.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Constitutional - Week 4 | 0.5 score on a scale | Standard Deviation 0.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Constitutional - Week 13 | 0.4 score on a scale | Standard Deviation 0.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Lymphadenopathy and lymphoma - Baseline | 0.5 score on a scale | Standard Deviation 0.8 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Lymphadenopathy and lymphoma - Week 4 | 0.3 score on a scale | Standard Deviation 0.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Lymphadenopathy and lymphoma - Week 13 | 0.4 score on a scale | Standard Deviation 0.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Glandular - Baseline | 0.7 score on a scale | Standard Deviation 0.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Glandular - Week 4 | 0.6 score on a scale | Standard Deviation 0.6 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Glandular - Week 13 | 0.4 score on a scale | Standard Deviation 0.6 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Articular - Baseline | 1.5 score on a scale | Standard Deviation 1.1 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Articular - Week 4 | 1.1 score on a scale | Standard Deviation 1.1 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Articular - Week 13 | 0.6 score on a scale | Standard Deviation 0.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Cutaneous - Baseline | 0.3 score on a scale | Standard Deviation 0.6 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Cutaneous - Week 4 | 0.2 score on a scale | Standard Deviation 0.6 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Cutaneous - Week 13 | 0.3 score on a scale | Standard Deviation 0.6 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Pulmonary - Baseline | 0.0 score on a scale | Standard Deviation 0.2 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Pulmonary - Week 4 | 0.0 score on a scale | Standard Deviation 0.2 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Pulmonary - Week 13 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Renal - Baseline | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Renal - Week 4 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Renal - Week 13 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Muscular - Baseline | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Muscular - Week 4 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Muscular - Week 13 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Peripheral Nervous System (PNS) - Baseline | 0.1 score on a scale | Standard Deviation 0.2 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Peripheral Nervous System (PNS) - Week 4 | 0.0 score on a scale | Standard Deviation 0.2 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Peripheral Nervous System (PNS) - Week 13 | 0.0 score on a scale | Standard Deviation 0.2 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Central Nervous System (CNS) - Baseline | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Central Nervous System (CNS) - Week 4 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Central Nervous System (CNS) - Week 13 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Hematological - Baseline | 0.6 score on a scale | Standard Deviation 0.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Hematological - Week 4 | 0.7 score on a scale | Standard Deviation 0.7 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Hematological - Week 13 | 0.8 score on a scale | Standard Deviation 0.8 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Biological - Baseline | 0.9 score on a scale | Standard Deviation 0.8 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Biological - Week 4 | 0.9 score on a scale | Standard Deviation 0.8 |
| S95011 Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Biological - Week 13 | 0.8 score on a scale | Standard Deviation 0.8 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Pulmonary - Week 4 | 0.3 score on a scale | Standard Deviation 0.6 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Total Score - Baseline | 13.1 score on a scale | Standard Deviation 7.2 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Peripheral Nervous System (PNS) - Week 13 | 0.2 score on a scale | Standard Deviation 0.6 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Total Score - Week 4 | 10.8 score on a scale | Standard Deviation 7.2 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Pulmonary - Week 13 | 0.2 score on a scale | Standard Deviation 0.6 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Total Score - Week 13 | 9.7 score on a scale | Standard Deviation 8.3 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Hematological - Week 4 | 0.5 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Constitutional - Baseline | 0.4 score on a scale | Standard Deviation 0.6 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Renal - Baseline | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Constitutional - Week 4 | 0.2 score on a scale | Standard Deviation 0.4 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Central Nervous System (CNS) - Baseline | 0.1 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Constitutional - Week 13 | 0.2 score on a scale | Standard Deviation 0.6 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Renal - Week 4 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Lymphadenopathy and lymphoma - Baseline | 0.6 score on a scale | Standard Deviation 0.6 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Biological - Week 13 | 1.1 score on a scale | Standard Deviation 0.9 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Lymphadenopathy and lymphoma - Week 4 | 0.3 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Renal - Week 13 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Lymphadenopathy and lymphoma - Week 13 | 0.4 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Central Nervous System (CNS) - Week 4 | 0.1 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Glandular - Baseline | 0.7 score on a scale | Standard Deviation 0.7 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Muscular - Baseline | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Glandular - Week 4 | 0.6 score on a scale | Standard Deviation 0.6 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Hematological - Week 13 | 0.4 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Glandular - Week 13 | 0.5 score on a scale | Standard Deviation 0.7 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Muscular - Week 4 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Articular - Baseline | 1.6 score on a scale | Standard Deviation 1.2 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Central Nervous System (CNS) - Week 13 | 0.1 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Articular - Week 4 | 1.3 score on a scale | Standard Deviation 1.3 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Muscular - Week 13 | 0.0 score on a scale | Standard Deviation 0 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Articular - Week 13 | 0.7 score on a scale | Standard Deviation 1 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Biological - Week 4 | 0.9 score on a scale | Standard Deviation 0.9 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Cutaneous - Baseline | 0.1 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Peripheral Nervous System (PNS) - Baseline | 0.2 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Cutaneous - Week 4 | 0.1 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Hematological - Baseline | 0.4 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Cutaneous - Week 13 | 0.2 score on a scale | Standard Deviation 0.8 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Peripheral Nervous System (PNS) - Week 4 | 0.2 score on a scale | Standard Deviation 0.5 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Pulmonary - Baseline | 0.3 score on a scale | Standard Deviation 0.6 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSDAI Score by Domain and Total Score | Biological - Baseline | 0.8 score on a scale | Standard Deviation 0.8 |
Secondary
ESSPRI Score by Symptom and Total Score
Efficacy criterion EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is an index designed to measure patients' symptoms in primary Sjögren's Syndrome. The three domains included in this scale are dryness, fatigue, and pain, each of which are scored on a scale of 0-10. The total score is calculated as the average of the three domain scores and therefore the maximum total score is 10. The higher score represents more severe symptoms.
Time frame: At baseline, week 4 and week 13
Population: The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline but observed data at other timepoints and inversely)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Total score - Baseline | 7.14 score on a scale | Standard Deviation 1.59 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Total score - Week 4 | 6.65 score on a scale | Standard Deviation 1.83 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Total score - Week 13 | 5.54 score on a scale | Standard Deviation 2.06 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Dryness score - Baseline | 7.46 score on a scale | Standard Deviation 1.69 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Dryness score - Week 4 | 6.96 score on a scale | Standard Deviation 2.2 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Dryness score - Week 13 | 6.54 score on a scale | Standard Deviation 1.91 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Fatigue score - Baseline | 7.43 score on a scale | Standard Deviation 1.43 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Fatigue score - Week 4 | 6.88 score on a scale | Standard Deviation 2.15 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Fatigue score - Week 13 | 5.71 score on a scale | Standard Deviation 2.74 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Pain score - Baseline | 6.54 score on a scale | Standard Deviation 2.63 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Pain score - Week 4 | 6.13 score on a scale | Standard Deviation 2.85 |
| S95011 Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Pain score - Week 13 | 4.38 score on a scale | Standard Deviation 3.21 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Pain score - Week 4 | 4.64 score on a scale | Standard Deviation 2.71 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Total score - Baseline | 6.87 score on a scale | Standard Deviation 1.65 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Fatigue score - Baseline | 7.18 score on a scale | Standard Deviation 2.24 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Total score - Week 4 | 5.19 score on a scale | Standard Deviation 1.97 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Pain score - Baseline | 6.35 score on a scale | Standard Deviation 2.21 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Total score - Week 13 | 5.40 score on a scale | Standard Deviation 2.71 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Fatigue score - Week 4 | 5.29 score on a scale | Standard Deviation 2.58 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Dryness score - Baseline | 7.06 score on a scale | Standard Deviation 2.38 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Pain score - Week 13 | 4.46 score on a scale | Standard Deviation 3.57 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Dryness score - Week 4 | 5.64 score on a scale | Standard Deviation 2.47 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Fatigue score - Week 13 | 5.15 score on a scale | Standard Deviation 3.21 |
| S95011 Placebo Concentrate for Solution for Infusion | ESSPRI Score by Symptom and Total Score | Dryness score - Week 13 | 6.62 score on a scale | Standard Deviation 2.43 |
Secondary
Fatigue (MFI)
Efficacy criterion Modified Fatigue Impact Scale (MFI) is a 20-item survey to evaluate five dimensions of fatigue. Scores range from 4 to 20 for each sub-score, with a lower score representing less fatigue.
Time frame: At baseline and week 13
Population: The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline (for all domains) but observed data at other timepoints and inversely).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| S95011 Concentrate for Solution for Infusion | Fatigue (MFI) | General fatigue score - Baseline | 15.1 score on a scale | Standard Deviation 3 |
| S95011 Concentrate for Solution for Infusion | Fatigue (MFI) | General fatigue score - Week 13 | 13.2 score on a scale | Standard Deviation 3.5 |
| S95011 Concentrate for Solution for Infusion | Fatigue (MFI) | Physical fatigue score - Baseline | 14.3 score on a scale | Standard Deviation 2.7 |
| S95011 Concentrate for Solution for Infusion | Fatigue (MFI) | Physical fatigue score - Week 13 | 12.6 score on a scale | Standard Deviation 3.9 |
| S95011 Concentrate for Solution for Infusion | Fatigue (MFI) | Reduced activity score - Baseline | 12.9 score on a scale | Standard Deviation 3 |
| S95011 Concentrate for Solution for Infusion | Fatigue (MFI) | Reduced activity score - Week 13 | 11.4 score on a scale | Standard Deviation 4.7 |
| S95011 Concentrate for Solution for Infusion | Fatigue (MFI) | Reduced motivation score - Baseline | 11.3 score on a scale | Standard Deviation 4.1 |
| S95011 Concentrate for Solution for Infusion | Fatigue (MFI) | Reduced motivation score - Week 13 | 10.3 score on a scale | Standard Deviation 4.5 |
| S95011 Concentrate for Solution for Infusion | Fatigue (MFI) | Mental fatigue score - Baseline | 11.6 score on a scale | Standard Deviation 3.9 |
| S95011 Concentrate for Solution for Infusion | Fatigue (MFI) | Mental fatigue score - Week 13 | 11.4 score on a scale | Standard Deviation 4.9 |
| S95011 Placebo Concentrate for Solution for Infusion | Fatigue (MFI) | Reduced motivation score - Week 13 | 8.8 score on a scale | Standard Deviation 4.5 |
| S95011 Placebo Concentrate for Solution for Infusion | Fatigue (MFI) | General fatigue score - Baseline | 15.2 score on a scale | Standard Deviation 3.6 |
| S95011 Placebo Concentrate for Solution for Infusion | Fatigue (MFI) | Reduced activity score - Week 13 | 9.7 score on a scale | Standard Deviation 4.3 |
| S95011 Placebo Concentrate for Solution for Infusion | Fatigue (MFI) | General fatigue score - Week 13 | 13.5 score on a scale | Standard Deviation 5.3 |
| S95011 Placebo Concentrate for Solution for Infusion | Fatigue (MFI) | Mental fatigue score - Week 13 | 9.5 score on a scale | Standard Deviation 4.1 |
| S95011 Placebo Concentrate for Solution for Infusion | Fatigue (MFI) | Physical fatigue score - Baseline | 13.9 score on a scale | Standard Deviation 3.9 |
| S95011 Placebo Concentrate for Solution for Infusion | Fatigue (MFI) | Reduced motivation score - Baseline | 9.1 score on a scale | Standard Deviation 3.1 |
| S95011 Placebo Concentrate for Solution for Infusion | Fatigue (MFI) | Physical fatigue score - Week 13 | 11.4 score on a scale | Standard Deviation 5.2 |
| S95011 Placebo Concentrate for Solution for Infusion | Fatigue (MFI) | Mental fatigue score - Baseline | 10.5 score on a scale | Standard Deviation 3.7 |
| S95011 Placebo Concentrate for Solution for Infusion | Fatigue (MFI) | Reduced activity score - Baseline | 12.3 score on a scale | Standard Deviation 3.8 |
Secondary
Number of Participants With Adverse Events (AEs)
Safety criterion
Time frame: Through study completion, up to Week 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| S95011 Concentrate for Solution for Infusion | Number of Participants With Adverse Events (AEs) | Patients having reported at least one treatment emergent adverse event (TEAE) | 24 Participants |
| S95011 Concentrate for Solution for Infusion | Number of Participants With Adverse Events (AEs) | Patients having reported at least one serious AE | 3 Participants |
| S95011 Placebo Concentrate for Solution for Infusion | Number of Participants With Adverse Events (AEs) | Patients having reported at least one treatment emergent adverse event (TEAE) | 11 Participants |
| S95011 Placebo Concentrate for Solution for Infusion | Number of Participants With Adverse Events (AEs) | Patients having reported at least one serious AE | 1 Participants |
Secondary
Patient's Global Assessment (PGA) of the Disease Activity
Efficacy criterion Patient's global assessment (PGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity.
Time frame: At baseline and week 13
Population: The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline but observed data at other timepoints and inversely)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| S95011 Concentrate for Solution for Infusion | Patient's Global Assessment (PGA) of the Disease Activity | Baseline | 7.1 score on a scale | Standard Deviation 2.1 |
| S95011 Concentrate for Solution for Infusion | Patient's Global Assessment (PGA) of the Disease Activity | Week 13 | 6.2 score on a scale | Standard Deviation 2.3 |
| S95011 Placebo Concentrate for Solution for Infusion | Patient's Global Assessment (PGA) of the Disease Activity | Baseline | 7.1 score on a scale | Standard Deviation 2.1 |
| S95011 Placebo Concentrate for Solution for Infusion | Patient's Global Assessment (PGA) of the Disease Activity | Week 13 | 5.4 score on a scale | Standard Deviation 2.8 |
Secondary
Physician's Global Assessment (PhGA) of the Disease Activity
Efficacy criterion Physician's global assessment (PhGA) of the disease activity is a 0 to 10 numerical rating scale (NRS), with a lower score representing less disease activity.
Time frame: At baseline and week 13
Population: The number analyzed for Week 13 is less due to missing patient data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| S95011 Concentrate for Solution for Infusion | Physician's Global Assessment (PhGA) of the Disease Activity | Baseline | 6.0 score on a scale | Standard Deviation 1.5 |
| S95011 Concentrate for Solution for Infusion | Physician's Global Assessment (PhGA) of the Disease Activity | Week 13 | 3.6 score on a scale | Standard Deviation 1.3 |
| S95011 Placebo Concentrate for Solution for Infusion | Physician's Global Assessment (PhGA) of the Disease Activity | Baseline | 6.3 score on a scale | Standard Deviation 1.3 |
| S95011 Placebo Concentrate for Solution for Infusion | Physician's Global Assessment (PhGA) of the Disease Activity | Week 13 | 4.2 score on a scale | Standard Deviation 1.6 |
Secondary
Quality of Life (SF-36)
Efficacy criterion The Short Form (SF-36) Health Survey is a 36-item, patient-reported survey of patient health to asses QoL. Scores for each subscale range from 0 - 100, with a lower number representing a worse quality of life.
Time frame: At baseline and week 13
Population: The number of analyzed participants at each timepoint is different than the overall number of participants analyzed due to missing data (e.g. some participants have missing data at baseline but observed data at other timepoints and inversely)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| S95011 Concentrate for Solution for Infusion | Quality of Life (SF-36) | Physical score - Baseline | 38.729 score on a scale | Standard Deviation 9.742 |
| S95011 Concentrate for Solution for Infusion | Quality of Life (SF-36) | Physical score - Week 13 | 45.139 score on a scale | Standard Deviation 9.409 |
| S95011 Concentrate for Solution for Infusion | Quality of Life (SF-36) | Mental score - Baseline | 40.911 score on a scale | Standard Deviation 10.909 |
| S95011 Concentrate for Solution for Infusion | Quality of Life (SF-36) | Mental score - Week 13 | 41.970 score on a scale | Standard Deviation 14.562 |
| S95011 Placebo Concentrate for Solution for Infusion | Quality of Life (SF-36) | Mental score - Week 13 | 45.050 score on a scale | Standard Deviation 14.275 |
| S95011 Placebo Concentrate for Solution for Infusion | Quality of Life (SF-36) | Physical score - Baseline | 40.295 score on a scale | Standard Deviation 8.236 |
| S95011 Placebo Concentrate for Solution for Infusion | Quality of Life (SF-36) | Mental score - Baseline | 44.182 score on a scale | Standard Deviation 13.208 |
| S95011 Placebo Concentrate for Solution for Infusion | Quality of Life (SF-36) | Physical score - Week 13 | 47.011 score on a scale | Standard Deviation 9.819 |