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A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02701985
First Posted: March 8, 2016
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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).

Condition Intervention Phase
Sjogren's Syndrome Drug: Placebo Drug: RO5459072 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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 [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • 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) 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 ESSPRI Pain Component Score at Week 12 [ Time Frame: Baseline (Week -1), Week 12 ]
  • Change From Baseline in Tear Flow Rate Using the Schirmer's Test 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 Auto-Antibody Titers at Weeks 6, and 12 [ Time Frame: Baseline, Week 6, and Week 12 ]
  • Plasma Concentration of RO5459072 [ Time Frame: Week 2, Week 6, and Week 12 ]
  • Percentage of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Baseline up to Week 14 ]

Enrollment: 75
Actual Study Start Date: July 5, 2016
Study Completion Date: July 10, 2017
Primary Completion Date: June 23, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching-placebo capsules will be administered orally, 2 times a day, for up to 12 weeks.
Drug: Placebo
Matching-placebo capsules will be administered orally, 2 times a day with food.
Experimental: RO5459072
RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day, for up to 12 weeks.
Drug: RO5459072
RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701985


  Hide Study Locations
Locations
United States, California
Wallace Rheumatic Study Center
Beverly Hills, California, United States, 90211
United States, Colorado
Denver Arthritis Clinic
Denver, Colorado, United States, 80230-7127
United States, Louisiana
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
John Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Michigan
University Of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, United States, 27617
United States, Ohio
MetroHealth System
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Clinical Research Center of Reading
Wyomissing, Pennsylvania, United States, 19610
United States, Tennessee
Ramesh Gupta - PP
Memphis, Tennessee, United States, 38119
France
Hopital Avicenne, Paris
Bobigny, France, 93009
C.H.U. Ambroise Pare (AP-HP)
Boulogne Billancourt, France, 92104
Hopital La Cavale Blanche; Rhumatologie
Brest, France, 29609
Hopital Lapeyronie; Immunologie Rhumatologie
Montpellier, France, 34295
Germany
Charité Research Organisation GmbH
Berlin, Germany, 10117
Poland
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob
Bydgoszcz, Poland, 85-168
MedPolonia
Poznan, Poland, 60-693
Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum.
Warszawa, Poland, 02-691
Centrum Medyczne AMED
Warszawa, Poland, 03-291
Portugal
Instituto Portugues de Reumatologia
Lisboa, Portugal, 1050-34
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
Lisboa, Portugal, 1649-035
Centro Hospitalar do Porto - Hospital de Santo António
Porto, Portugal, 4099-001
Centro Hospitalar de Sao Joao,E.P.E.
Porto, Portugal, 4200-319
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Barts and the London NHS Trust
London, United Kingdom, E1 2ES
University College London Hospitals NHS Foundation Trust - University College Hospital
London, United Kingdom, NW1 2BU
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE1 4LP
Sheffield Teaching Hospitals NHS Foundation Trust; Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Great Western Hospitals NHS Foundation Trust.
Wiltshire, United Kingdom, SN3 6BB
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02701985     History of Changes
Other Study ID Numbers: BP30037
2015-004476-30 ( EudraCT Number )
First Submitted: March 3, 2016
First Posted: March 8, 2016
Last Update Posted: July 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases