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A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

NCT03001219 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2020-01-29

Study results available
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Summary

This is a Phase IIa/b double-blind, placebo-controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of RO7123520 as adjunctive therapy in participants with RA who are inadequately responding to standard-of-care (methotrexate and anti-TNF-alpha therapy). Part 1 of the study will evaluate safety. Part 2 will evaluate efficacy and safety. Part 3 will evaluate dose-ranging efficacy. Participants will have the option of continuing to the extension period of the study.

Conditions

Interventions

DRUG

Anti-TNF-alpha

Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.

DRUG

Methotrexate

Participants will continue their pre-trial methotrexate therapy at a stable dose.

DRUG

Placebo

Participants will receive intravenous infusion of placebo.

DRUG

RO7123520

Participants will receive intravenous infusion of RO7123520.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-22
Primary Completion
2018-11-06
Completion
2018-11-06

Countries

  • United States
  • Argentina
  • Austria
  • Colombia
  • Germany
  • Guatemala
  • Italy
  • Mexico
  • Peru
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03001219 on ClinicalTrials.gov