Back to resultsA Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
Primary Purpose
Sjogren's Syndrome
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
RO5459072
Sponsored by
About this trial
This is an interventional treatment trial for Sjogren's Syndrome
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of primary Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
- ESSDAI score greater than or equal to (>/=) 5
- ESSPRI score >/=5
- Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening
- Negative pregnancy test at screening and baseline (for women only)
- Willing to comply with the study procedures and restrictions, including measures to prevent pregnancy and restrictions on sperm donation
Exclusion Criteria:
- A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria
- Severe complications of Sjogren's syndrome
- Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy within 6 months prior to the screening visit
- Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day
- A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal, yeast or bacterial infection at screening
- A history suggesting reduced immune function or any other conditions predisposing participants to serious infection
- A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance (MGUS), or any other malignancies within the past 5 years
- A diagnosis of fibromyalgia or significant depression
- Having any concomitant disease or condition that could interfere with the conduct of the study, or that would pose an unacceptable risk to the individual
- Participation in an investigational drug or device study within 3 months prior to screening
- Inability to comply with the study protocol for any other reason
- Women who are lactating, breastfeeding or planning to nurse
- Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein [P-gp]; sensitive substrates of CYP3A4 with a narrow therapeutic index)
Sites / Locations
- Wallace Rheumatic Study Center
- Denver Arthritis Clinic
- Ochsner Clinic Foundation
- John Hopkins Bayview Medical Center
- University Of Michigan
- Winthrop University Hospital
- Shanahan Rheumatology & Immunology, PLLC
- MetroHealth System
- Altoona Center For Clinical Research
- University of Pittsburgh Medical Center
- Clinical Research Center of Reading
- Ramesh Gupta - PP
- Hopital Avicenne, Paris
- C.H.U. Ambroise Pare (AP-HP)
- Hopital La Cavale Blanche; Rhumatologie
- Hopital Lapeyronie; Immunologie Rhumatologie
- Charité Research Organisation GmbH
- Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
- MedPolonia
- Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum.
- Centrum Medyczne AMED
- Instituto Portugues de Reumatologia
- Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
- Centro Hospitalar do Porto - Hospital de Santo António
- Centro Hospitalar de Sao Joao,E.P.E.
- University Hospitals Birmingham NHS Foundation Trust
- Barts and the London NHS Trust
- University College London Hospitals NHS Foundation Trust - University College Hospital
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Sheffield Teaching Hospitals NHS Foundation Trust; Royal Hallamshire Hospital
- Great Western Hospitals NHS Foundation Trust.
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
RO5459072
Arm Description
Matching-placebo capsules will be administered orally, 2 times a day, for up to 12 weeks.
RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day, for up to 12 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score
Percentage of participants with a clinically relevant decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score is defined as participants with absolute decrease of ≥ 3-points in ESSDAI score. ESSDAI is physician-assessed disease activity index developed by EULAR consortium consisting of 44 items in 12 organ-specific 'domains' (constitutional,lymphadenopathy, articular,muscular,cutaneous,glandular,pulmonary,renal,peripheral nervous system,central nervous system,hematological,biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A score ≥ 5 is considered moderate or severe disease activity and a clinically relevant change in ESSDAI score is defined as absolute decrease of ≥ 3-points.
Secondary Outcome Measures
Percentage of Participants With a Clinically Relevant Decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score
The efficacy of RO5459072 in patients with primary Sjogren's Syndrome Disease is evaluated in terms of the percentage of participants with a clinically relevant decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score, where a clinically relevant decrease in ESSPRI score is defined as a decrease of ≥ 1 point. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains where all domains carry same weight.
Change From Baseline in ESSDAI Score at Week 12
Change from baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSDAI is a physician-assessed disease activity index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific 'domains' contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity).
Change From Baseline in ESSPRI Score at Week 12
Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight.
Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Score at Week 12
Change from baseline in Short Form-36 Health Survey (SF-36) Mental score is defined as the change in score between baseline (Week -1) and Week 12. The SF-36 was used to assess health-related quality of life at baseline and at on-treatment visits. The SF-36 consisted of 36 questions covering 8 domains (general health, physical functioning, role-functioning physical, bodily pain, social functioning, role-functioning emotional, mental health, and vitality), with each domain scoring on a scale 0-100 (a score of 0 = maximum disability and a score of 100 = no disability). Reported here is the mental health domain score.
Change From Baseline in SF-36 Physical Score at Week 12
Change from baseline in Short Form-36 Health Survey (SF-36) Physical Score is defined as the change in score between baseline (Week -1) and Week 12. The SF-36 was used to assess health-related quality of life at baseline and at on-treatment visits. The SF-36 consisted of 36 questions covering 8 domains (general health, physical functioning, role-functioning physical, bodily pain, social functioning, role-functioning emotional, mental health, and vitality), with each domain scoring on a scale 0-100. (a score of 0 = maximum disability and a score of 100 = no disability)
Change From Baseline in ESSPRI Dryness Component Score at Week 12
Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) dryness component score is defined as the change in score between baseline (Week -1) and Week 12. The Dryness Component score ranged from 0-10 (0 =no symptom at all and 10 = worst symptom imaginable).
Change From Baseline in ESSPRI Fatigue Component Score at Week 12
Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) fatigue component score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI score consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable).
Change From Baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Pain Component Score at Week 12
Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) pain component score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI score consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (Each domain scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable).
Change From Baseline in Tear Flow Rate at Weeks 2, 6, and 12
Un-stimulated tear production rate was measured from both eyes (without the use of analgesics/ anesthetic drops) at baseline and at on-treatment visits using the Schirmer method. A thin strip of filter paper (Schirmer strip, e.g., 35 x 5 mm) was placed at the junction of the lateral and middle thirds of the lower eyelid of each eye. The maximum length of wetting along the strip at the end of the test period was measured.
Change From Baseline in Mechanically Stimulated Salivary Flow Rate at Weeks 2, 6, and 12
Change from baseline in mechanically stimulated salivary flow rate is defined as the change in flow (mL/min) between baseline (Week -1) and Week 2, Week 6 and Week 12. Using a mechanical stimulation method of a piece of neutral wax, paraffin, silicone, unflavored chewing gum, or similar chewable, unflavored, nonabsorbent material, patients were instructed to chew for a period of 5 minutes. The stimulated salivary flow rate was calculated assuming a specific gravity of 1 (i.e., 1 mL saliva = 1 g) and expressed in mL per minute.
Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen A at Weeks 6, and 12
Anti-Sjögren's-syndrome-related antigen A is a type of antibody found in the auto-antibody titers.
Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen B at Weeks 6, and 12
Anti-Sjögren's-syndrome-related antigen B is a type of antibody found in the auto-antibody titers.
Change From Baseline in Rheumatoid Factor at Weeks 6, and 12
Rheumatoid factor is a type of auto-antibody found in the auto-antibody titers.
Change From Baseline in Total Immunoglobulin G (IgG) at Weeks 6, and 12
Total IgG is a type of auto-antibody found in the auto-antibody titers.
Change From Baseline in Total Immunoglobulin M (IgM) at Weeks 6, and 12
Total IgM is a type of auto-antibody found in the auto-antibody titers.
Minimum Concentration (Cmin) of RO5459072
Minimum observed plasma concentration (mass/volume)
Maximum Concentration (Cmax) of RO5459072
Maximum observed plasma concentration (mass/volume)
Average Concentration (Caverage) of RO5459072
Average observed plasma concentration (mass/volume)
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02701985
Brief Title
A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 5, 2016 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group study designed to evaluate the effects of RO5459072 treatment on disease activity and symptoms of Sjogren's syndrome in adult participants with moderate to severe primary Sjogren's syndrome. The total duration of the study for each participant will be approximately 18 weeks (including screening).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching-placebo capsules will be administered orally, 2 times a day, for up to 12 weeks.
Arm Title
RO5459072
Arm Type
Experimental
Arm Description
RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day, for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching-placebo capsules will be administered orally, 2 times a day with food.
Intervention Type
Drug
Intervention Name(s)
RO5459072
Intervention Description
RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score
Description
Percentage of participants with a clinically relevant decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score is defined as participants with absolute decrease of ≥ 3-points in ESSDAI score. ESSDAI is physician-assessed disease activity index developed by EULAR consortium consisting of 44 items in 12 organ-specific 'domains' (constitutional,lymphadenopathy, articular,muscular,cutaneous,glandular,pulmonary,renal,peripheral nervous system,central nervous system,hematological,biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A score ≥ 5 is considered moderate or severe disease activity and a clinically relevant change in ESSDAI score is defined as absolute decrease of ≥ 3-points.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With a Clinically Relevant Decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score
Description
The efficacy of RO5459072 in patients with primary Sjogren's Syndrome Disease is evaluated in terms of the percentage of participants with a clinically relevant decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score, where a clinically relevant decrease in ESSPRI score is defined as a decrease of ≥ 1 point. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains where all domains carry same weight.
Time Frame
12 weeks
Title
Change From Baseline in ESSDAI Score at Week 12
Description
Change from baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSDAI is a physician-assessed disease activity index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific 'domains' contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity).
Time Frame
Baseline (Week -1), Week 12
Title
Change From Baseline in ESSPRI Score at Week 12
Description
Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight.
Time Frame
Baseline (Week -1), Week 12
Title
Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Score at Week 12
Description
Change from baseline in Short Form-36 Health Survey (SF-36) Mental score is defined as the change in score between baseline (Week -1) and Week 12. The SF-36 was used to assess health-related quality of life at baseline and at on-treatment visits. The SF-36 consisted of 36 questions covering 8 domains (general health, physical functioning, role-functioning physical, bodily pain, social functioning, role-functioning emotional, mental health, and vitality), with each domain scoring on a scale 0-100 (a score of 0 = maximum disability and a score of 100 = no disability). Reported here is the mental health domain score.
Time Frame
Baseline (Week -1), Week 12
Title
Change From Baseline in SF-36 Physical Score at Week 12
Description
Change from baseline in Short Form-36 Health Survey (SF-36) Physical Score is defined as the change in score between baseline (Week -1) and Week 12. The SF-36 was used to assess health-related quality of life at baseline and at on-treatment visits. The SF-36 consisted of 36 questions covering 8 domains (general health, physical functioning, role-functioning physical, bodily pain, social functioning, role-functioning emotional, mental health, and vitality), with each domain scoring on a scale 0-100. (a score of 0 = maximum disability and a score of 100 = no disability)
Time Frame
Baseline (Week -1), Week 12
Title
Change From Baseline in ESSPRI Dryness Component Score at Week 12
Description
Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) dryness component score is defined as the change in score between baseline (Week -1) and Week 12. The Dryness Component score ranged from 0-10 (0 =no symptom at all and 10 = worst symptom imaginable).
Time Frame
Baseline (Week -1), Week 12
Title
Change From Baseline in ESSPRI Fatigue Component Score at Week 12
Description
Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) fatigue component score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI score consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable).
Time Frame
Baseline (Week -1), Week 12
Title
Change From Baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Pain Component Score at Week 12
Description
Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) pain component score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI score consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (Each domain scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable).
Time Frame
Baseline (Week -1), Week 12
Title
Change From Baseline in Tear Flow Rate at Weeks 2, 6, and 12
Description
Un-stimulated tear production rate was measured from both eyes (without the use of analgesics/ anesthetic drops) at baseline and at on-treatment visits using the Schirmer method. A thin strip of filter paper (Schirmer strip, e.g., 35 x 5 mm) was placed at the junction of the lateral and middle thirds of the lower eyelid of each eye. The maximum length of wetting along the strip at the end of the test period was measured.
Time Frame
Baseline, Week 2, Week 6, and Week 12
Title
Change From Baseline in Mechanically Stimulated Salivary Flow Rate at Weeks 2, 6, and 12
Description
Change from baseline in mechanically stimulated salivary flow rate is defined as the change in flow (mL/min) between baseline (Week -1) and Week 2, Week 6 and Week 12. Using a mechanical stimulation method of a piece of neutral wax, paraffin, silicone, unflavored chewing gum, or similar chewable, unflavored, nonabsorbent material, patients were instructed to chew for a period of 5 minutes. The stimulated salivary flow rate was calculated assuming a specific gravity of 1 (i.e., 1 mL saliva = 1 g) and expressed in mL per minute.
Time Frame
Baseline, Week 2, Week 6, and Week 12
Title
Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen A at Weeks 6, and 12
Description
Anti-Sjögren's-syndrome-related antigen A is a type of antibody found in the auto-antibody titers.
Time Frame
Baseline, Week 6, and Week 12
Title
Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen B at Weeks 6, and 12
Description
Anti-Sjögren's-syndrome-related antigen B is a type of antibody found in the auto-antibody titers.
Time Frame
Baseline, Week 6, and Week 12
Title
Change From Baseline in Rheumatoid Factor at Weeks 6, and 12
Description
Rheumatoid factor is a type of auto-antibody found in the auto-antibody titers.
Time Frame
Baseline, Week 6, and Week 12
Title
Change From Baseline in Total Immunoglobulin G (IgG) at Weeks 6, and 12
Description
Total IgG is a type of auto-antibody found in the auto-antibody titers.
Time Frame
Baseline, Week 6, and Week 12
Title
Change From Baseline in Total Immunoglobulin M (IgM) at Weeks 6, and 12
Description
Total IgM is a type of auto-antibody found in the auto-antibody titers.
Time Frame
Baseline, Week 6, and Week 12
Title
Minimum Concentration (Cmin) of RO5459072
Description
Minimum observed plasma concentration (mass/volume)
Time Frame
Week 2, Week 6, and Week 12
Title
Maximum Concentration (Cmax) of RO5459072
Description
Maximum observed plasma concentration (mass/volume)
Time Frame
Week 2, Week 6, and Week 12
Title
Average Concentration (Caverage) of RO5459072
Description
Average observed plasma concentration (mass/volume)
Time Frame
Week 2, Week 6, and Week 12
Title
Percentage of Participants With Adverse Events
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
Baseline up to Week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A diagnosis of primary Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
ESSDAI score greater than or equal to (>/=) 5
ESSPRI score >/=5
Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening
Negative pregnancy test at screening and baseline (for women only)
Willing to comply with the study procedures and restrictions, including measures to prevent pregnancy and restrictions on sperm donation
Exclusion Criteria:
A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria
Severe complications of Sjogren's syndrome
Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy within 6 months prior to the screening visit
Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day
A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal, yeast or bacterial infection at screening
A history suggesting reduced immune function or any other conditions predisposing participants to serious infection
A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance (MGUS), or any other malignancies within the past 5 years
A diagnosis of fibromyalgia or significant depression
Having any concomitant disease or condition that could interfere with the conduct of the study, or that would pose an unacceptable risk to the individual
Participation in an investigational drug or device study within 3 months prior to screening
Inability to comply with the study protocol for any other reason
Women who are lactating, breastfeeding or planning to nurse
Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein [P-gp]; sensitive substrates of CYP3A4 with a narrow therapeutic index)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Wallace Rheumatic Study Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230-7127
Country
United States
Facility Name
Ochsner Clinic Foundation
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
John Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
University Of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Shanahan Rheumatology & Immunology, PLLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Clinical Research Center of Reading
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Ramesh Gupta - PP
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Hopital Avicenne, Paris
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
C.H.U. Ambroise Pare (AP-HP)
City
Boulogne Billancourt
ZIP/Postal Code
92104
Country
France
Facility Name
Hopital La Cavale Blanche; Rhumatologie
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hopital Lapeyronie; Immunologie Rhumatologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Charité Research Organisation GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
MedPolonia
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum.
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Instituto Portugues de Reumatologia
City
Lisboa
ZIP/Postal Code
1050-34
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar do Porto - Hospital de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao,E.P.E.
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Barts and the London NHS Trust
City
London
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust - University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust; Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Great Western Hospitals NHS Foundation Trust.
City
Wiltshire
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
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