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COMPLETED Phase 2

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

NCT02701985 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 75 participants
Start Date 2016-07-05
Est. Completion 2017-07-10
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02701985

The ClinicalTrials.gov registry entry for NCT02701985 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02701985 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02701985?

The interventions under investigation include: Placebo (DRUG), RO5459072 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02701985?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial