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NCT02701985 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome
A Phase 2 study of Sjogren's Syndrome, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT02701985: Completed Phase 2 study of Sjogren's Syndrome, sponsored by Hoffmann-La Roche.
NCT02701985 is a Phase 2 study of Sjogren's Syndrome that has completed, run by Hoffmann-La Roche. The registered enrollment target is 75 participants, below the 285-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02701985, a Phase 2 study of Sjogren's Syndrome, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
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,cen
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RO5459072
Study Locations (20)
Other
- Hopital Avicenne, Paris - Bobigny
- C.H.U. Ambroise Pare (AP-HP) - Boulogne-Billancourt
- Hopital La Cavale Blanche; Rhumatologie - Brest
- Hopital Lapeyronie; Immunologie Rhumatologie - Montpellier
- Charité Research Organisation GmbH - Berlin
- Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob - Bydgoszcz
- MedPolonia - Poznan
- Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum. - Warsaw
Pennsylvania
- Altoona Center For Clinical Research - Duncansville
- University of Pittsburgh Medical Center - Pittsburgh
- Clinical Research Center of Reading - Wyomissing
California
- Wallace Rheumatic Study Center - Beverly Hills
Colorado
- Denver Arthritis Clinic - Denver
Louisiana
- Ochsner Clinic Foundation - Baton Rouge
Maryland
- John Hopkins Bayview Medical Center - Baltimore
Michigan
- University Of Michigan - Ann Arbor
New York
- Winthrop University Hospital - Mineola
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2016-07-05 |
| Est. Completion | 2017-07-10 |
| Phase | Phase 2 |
What the finished NCT02701985 record still lists
NCT02701985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 285-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Sjogren's Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02701985 names 20 study sites across 11 states, led by Other, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT02701985 about?
NCT02701985 is a clinical study titled "A Study to Assess the Efficacy of RO5459072 in Participants 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 ...
What is the current status of trial NCT02701985?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2016-07-05. Estimated completion is 2017-07-10.
What conditions does trial NCT02701985 study?
This clinical trial studies the following conditions: Sjogren's Syndrome.
What interventions are being tested in trial NCT02701985?
The interventions under investigation include: Placebo (DRUG), RO5459072 (DRUG).
Who is sponsoring clinical trial NCT02701985?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02701985 being conducted?
This trial has 20 study locations across California, Colorado, Louisiana, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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