Summary

for people ages 18-80 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

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.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors

Keywords

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Methotrexate Anti-TNF-alpha RO7123520

Eligibility

You can join if…

Open to people ages 18-80

  • Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening
  • Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2
  • For Part 2 only: Active synovitis and/or osteitis of the dominant hand/wrist as determined by contrast-enhanced magnetic resonance imaging
  • Participants must be taking stable dose of anti-TNF-alpha therapies
  • Participants on stable oral glucocorticoids within 6 weeks of planned randomization
  • Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (up to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID use (on stable dose for ≥ 4 weeks)

You CAN'T join if...

  • Currently receiving concomitant treatment with sulfasalazine, or leflunomide. Note:Enrollment is allowed after an appropriate wash-out period
  • Participants currently on intravenous (IV) infliximab or an approved IV biosimilar of it
  • Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study
  • Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization
  • Active inflammatory diseases of the joints not related to RA
  • Systemic autoimmune disease other than RA
  • Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16
  • Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator
  • RA participants functional status class IV according to the ACR 1991 criteria
  • Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
  • History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
  • Any identified confirmed congenital or acquired immunodeficiency
  • Abnormal laboratory values and liver function test
  • Myocardial infarction within less than 6 months prior to participation in the study
  • Severe central or peripheral nervous system diseases

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • Advanced Medical Research, LLC accepting new patients
    Lakewood California 90712 United States
  • Medvin Clinical Research accepting new patients
    Covina California 91723 United States
  • Centro de Investigación; Artritis y Osteoporosis S.C. accepting new patients
    Mexicali 21200 Mexico
  • Centro de Investigacion del Noroeste SC accepting new patients
    Tijuana BAJA California 22010 Mexico
  • Arizona Arthritis & Rheumatology Research, PLLC accepting new patients
    Phoenix Arizona 85037 United States
  • Arizona Arthritis & Rheumatology Associates, P.C. accepting new patients
    Glendale Arizona 85306 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT03001219
Phase
Phase 2
Study Type
Interventional
Last Updated
June 14, 2018