Sjogren's SyndromePhase 2NCT02701985
A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
A Phase 2 study testing RO5459072 in people with Sjogren's Syndrome, run by Hoffmann-La Roche at 31 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- RO5459072
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 31 sitesin 6 countries
- Study dates
- 5 Jul 2016to 10 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
31 sites in 6 countries.
31 sites in 6 countries
United States12 sites
University Of Michigan
Ann Arbor, Michigan, 48109
John Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70809
Wallace Rheumatic Study Center
Beverly Hills, California, 90211
MetroHealth System
Cleveland, Ohio, 44109
Denver Arthritis Clinic
Denver, Colorado, 80230-7127
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635
Ramesh Gupta - PP
Memphis, Tennessee, 38119
Winthrop University Hospital
Mineola, New York, 11501
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, 27617
Clinical Research Center of Reading
Wyomissing, Pennsylvania, 19610
United Kingdom6 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Barts and the London NHS Trust
London, E1 2ES
University College London Hospitals NHS Foundation Trust - University College Hospital
London, NW1 2PG
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP
Sheffield Teaching Hospitals NHS Foundation Trust; Royal Hallamshire Hospital
Sheffield, S10 2JF
Great Western Hospitals NHS Foundation Trust.
Wiltshire, SN3 6BB
France4 sites
Hopital Avicenne, Paris
Bobigny, 93009
C.H.U. Ambroise Pare (AP-HP)
Boulogne-Billancourt, 92104
Hopital La Cavale Blanche; Rhumatologie
Brest, 29609
Hopital Lapeyronie; Immunologie Rhumatologie
Montpellier, 34295
Poland4 sites
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
Bydgoszcz, 85-168
MedPolonia
Poznan, 60-693
Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum.
Warsaw, 02-691
Centrum Medyczne AMED
Warsaw, 03-291
Portugal4 sites
Instituto Portugues de Reumatologia
Lisbon, 1050-34
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
Lisbon, 1649-035
Centro Hospitalar do Porto - Hospital de Santo António
Porto, 4099-001
Centro Hospitalar de Sao Joao,E.P.E.
Porto, 4200-319
About this study
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
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).
- Conditions
- Sjogren's Syndrome
- Being tested
- Placebo, RO5459072
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching-placebo capsules will be administered orally, 2 times a day with food.
RO5459072Drug
RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching-placebo capsules will be administered orally, 2 times a day, for up to 12 weeks. Receives: Drug: Placebo |
| RO5459072 | Experimental | RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day, for up to 12 weeks. Receives: Drug: RO5459072 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (19)
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.
Measured: 12 weeks
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).
Measured: Baseline (Week -1), Week 12
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.
Measured: Baseline (Week -1), Week 12
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.
Measured: Baseline (Week -1), Week 12
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)
Measured: Baseline (Week -1), Week 12
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).
Measured: Baseline (Week -1), Week 12
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).
Measured: Baseline (Week -1), Week 12
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).
Measured: Baseline (Week -1), Week 12
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.
Measured: Baseline, Week 2, Week 6, and Week 12
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.
Measured: Baseline, Week 2, Week 6, and Week 12
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.
Measured: Baseline, Week 6, and Week 12
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.
Measured: Baseline, Week 6, and Week 12
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.
Measured: Baseline, Week 6, and Week 12
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.
Measured: Baseline, Week 6, and Week 12
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.
Measured: Baseline, Week 6, and Week 12
Minimum Concentration (Cmin) of RO5459072
Minimum observed plasma concentration (mass/volume)
Measured: Week 2, Week 6, and Week 12
Maximum Concentration (Cmax) of RO5459072
Maximum observed plasma concentration (mass/volume)
Measured: Week 2, Week 6, and Week 12
Average Concentration (Caverage) of RO5459072
Average observed plasma concentration (mass/volume)
Measured: Week 2, Week 6, and Week 12
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.
Measured: Baseline up to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start5 Jul 2016
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701985
- Sponsor's protocol ID
- BP30037
- Other IDs
- 2015-004476-30, 2015
- Status last verified
- Jul 2018
- First submitted
- 3 Mar 2016
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Bentley D, Fisher BA, Barone F, Kolb FA, Attley G. A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjogren's syndrome. Rheumatology (Oxford). 2023 Nov 2;62(11):3644-3653. doi: 10.1093/rheumatology/kead092.
PubMed 36864622
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02701985
- Acronym / sponsor ID
- BP30037
- Conditions
- Sjogren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 1 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatching-placebo capsules will be administered orally, 2 times a day, for up to 12 weeks. |
| RO5459072 | Experimental | Drug: RO5459072RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day, for up to 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboMatching-placebo capsules will be administered orally, 2 times a day with food. | Drug | Placebo |
| RO5459072RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food. | Drug | RO5459072 |
Primary outcome
Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score
Time frame: 12 weeks
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.
19 secondary outcomes
Percentage of Participants With a Clinically Relevant Decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score
Time frame: 12 weeks
Change From Baseline in ESSDAI Score at Week 12
Time frame: Baseline (Week -1), Week 12
Change From Baseline in ESSPRI Score at Week 12
Time frame: Baseline (Week -1), Week 12
Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Score at Week 12
Time frame: Baseline (Week -1), Week 12
Change From Baseline in SF-36 Physical Score at Week 12
Time frame: Baseline (Week -1), Week 12
Change From Baseline in ESSPRI Dryness Component Score at Week 12
Time frame: Baseline (Week -1), Week 12
Change From Baseline in ESSPRI Fatigue Component Score at Week 12
Time frame: Baseline (Week -1), Week 12
Change From Baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Pain Component Score at Week 12
Time frame: Baseline (Week -1), Week 12
Change From Baseline in Tear Flow Rate at Weeks 2, 6, and 12
Time frame: Baseline, Week 2, Week 6, and Week 12
Change From Baseline in Mechanically Stimulated Salivary Flow Rate at Weeks 2, 6, and 12
Time frame: Baseline, Week 2, Week 6, and Week 12
Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen A at Weeks 6, and 12
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen B at Weeks 6, and 12
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Rheumatoid Factor at Weeks 6, and 12
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Total Immunoglobulin G (IgG) at Weeks 6, and 12
Time frame: Baseline, Week 6, and Week 12
Change From Baseline in Total Immunoglobulin M (IgM) at Weeks 6, and 12
Time frame: Baseline, Week 6, and Week 12
Minimum Concentration (Cmin) of RO5459072
Time frame: Week 2, Week 6, and Week 12
Maximum Concentration (Cmax) of RO5459072
Time frame: Week 2, Week 6, and Week 12
Average Concentration (Caverage) of RO5459072
Time frame: Week 2, Week 6, and Week 12
Percentage of Participants With Adverse Events
Time frame: Baseline up to Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36864622Bentley D, Fisher BA, Barone F, Kolb FA, Attley G. A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjogren's syndrome. Rheumatology (Oxford). 2023 Nov 2;62(11):3644-3653. doi: 10.1093/rheumatology/kead092.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
31 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO5459072 in people with Sjogren's Syndrome, run by Hoffmann-La Roche at 31 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, United Kingdom, France, Poland, Portugal and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.