Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001526-59 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ADIR, a Servier Group company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S95011 concentrate for solution for infusion | Experimental | S95011 is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. |
|
| S95011 Placebo concentrate for solution for infusion | Placebo Comparator | S95011 placebo is administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S95011 concentrate for solution for infusion | Drug | IV administration every 2 weeks until week 4 and then every 3 weeks until week 10. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Prior administration within the timeframe described in the protocol of any of the following:
Meeting any of the following conditions:
Secondary Sjögren's Syndrome
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Arthritis Associates | Lakewood | Colorado | 80228 | United States | ||
| Altoona Center for Clinical Research |
Not provided
| Label | URL |
|---|---|
| Find Results on Servier Clinical Trial Data website | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.
Access can be requested for all interventional clinical studies:
The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.
In addition, access can be requested for all interventional clinical studies in patients:
After Marketing Authorisation in EEA or US if the study is used for the approval.
Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | S95011 Placebo Concentrate for Solution for Infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2022 | Jan 15, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo concentrate for solution for infusion | Drug | IV administration every 2 weeks until week 4 and then every 3 weeks until week 10. |
|
| At baseline, week 4 and week 13 |
| 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. | At baseline, week 4 and week 13 |
| 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. | At baseline and week 13 |
| 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. | At baseline and week 13 |
| 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. | At baseline and week 13 |
| 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. | At baseline and week 13 |
| Number of Participants With Adverse Events (AEs) | Safety criterion | Through study completion, up to Week 28 |
| Duncansville |
| Pennsylvania |
| 16635 |
| United States |
| The Queen Elizabeth Hospital Rheumatology Unit | Woodville | 5011 | Australia |
| Hôpital Saint-André | Bordeaux | 33000 | France |
| CHU de Bicêtre | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital Laribiosière | Paris | 75010 | France |
| Hôpital Pitié-Salpêtrière | Paris | 75013 | France |
| Hôpital Saint Antoine | Paris | 75571 | France |
| Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie | Erlangen | 91054 | Germany |
| Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie | Freiburg im Breisgau | 79106 | Germany |
| Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék | Debrecen | 4032 | Hungary |
| Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia | Gyula | 5700 | Hungary |
| Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő | Székesfehérvár | 8000 | Hungary |
| CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos | Barcelona | 08022 | Spain |
| CLINICAL GAIAS SANTIAGO Servicio de Reumatología | Santiago de Compostela | 15702 | Spain |
| Hospital Infanta Luisa Quirón Salud Servicio de Reumatología | Seville | 41010 | Spain |
| Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2TH | United Kingdom |
| Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Southampton General Hospital, University Hospital Southampton NHS Trust | Southampton | SO16 6YD | United Kingdom |
| Study Protocol | View IPD |
| Statistical Analysis Plan | View IPD |
| Informed Consent Form | View IPD |
| Clinical Study Report | View IPD |
| study-level clinical trial data | View IPD |
S95011 placebo was administrated by one IV infusion every 2 weeks for the first month and then every 3 weeks.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Duration since diagnosis of pSS (years) | Mean | Standard Deviation | years |
| |||||||||||||||
| Patient taking a specific treatment for pSS (for randomization stratification) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Change in ESSDAI Total Score is computed only on observed values before occurrence of Intercurrent Events. | Posted | Mean | Standard Deviation | score on a scale | From baseline to week 13 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | At baseline, week 4 and week 13 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | At baseline, week 4 and week 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | At baseline and week 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Mean | Standard Deviation | score on a scale | At baseline and week 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | The number analyzed for Week 13 is less due to missing patient data. | Posted | Mean | Standard Deviation | score on a scale | At baseline and week 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | At baseline and week 13 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | Safety criterion | Posted | Count of Participants | Participants | Through study completion, up to Week 28 |
|
|
Through Week 28 (about 6 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 31 | 3 | 31 | 24 | 31 |
| EG001 | 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. | 0 | 17 | 1 | 17 | 11 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Amaurosis fugax | Eye disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Vascular stent stenosis | General disorders | MedDRA (25.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Salivary gland pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA (25.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (25.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (25.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Studies Department | Institut de Recherches Internationales Servier (I.R.I.S.) | +33 1 55 72 60 00 | scientificinformation@servier.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2023 | Jan 15, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D001327 | Autoimmune Diseases |
| D014987 | Xerostomia |
| D014985 | Xerophthalmia |
| D012466 | Salivary Gland Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D003229 | Conjunctival Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or other Pacific Islander |
|
| Other |
|
| Not Hispanic or Latino |
|
| Oral corticosteroid |
|
| Antimalarial |
|
| Oral corticosteroid and antimalarial |
|
| Baseline |
|
|
| Week 13 |
|
|
S95011 placebo is 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. |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
| Participants |
|
|
|