🏛️ Verified NIH Record • Updated 2026-05-12

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus (NCT04963296)

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

Who can join: Review the eligibility criteria below.

Location: Pinnacle Research Group — Anniston, Alabama

Age range: 18 Years to 75 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (64 Sites)

Showing the first 25 of 64 sites.

  • Pinnacle Research Group — Anniston, Alabama
  • Unity Health - White County Medical Center- Rheumatology — Searcy, Arkansas
  • Providence Medical Foundation — Fullerton, California
  • Arthritis & Rheumatism — Aventura, Florida
  • Great Lakes Center of Rheumatology — Lansing, Michigan
  • Clinical Research Institute of Michigan, LLC — Troy, Michigan
  • Northwell Health Division of Rheumatology — Great Neck, New York
  • Columbia University Medical Center — New York, New York
  • Joint & Muscle Research Institute — Charlotte, North Carolina
  • The Ohio State University Wexner Medical Center — Columbus, Ohio
  • Paramount Medical Research & Consulting, LLC — Middleburg Heights, Ohio
  • Precision Comprehensive Clinical Research Solutions — Colleyville, Texas
  • Texas Arthritis Center — El Paso, Texas
  • Prolato Clinical Research Center — Houston, Texas
  • Organizacion Medica de Investigacion — Buenos Aires,
  • DOM Centro de Reumatología — Buenos Aires,
  • Centro de Investigaciones Médicas Tucuman — San Miguel,
  • Ser Servicos Especializados Em Reumatologia — Salvador, Estado de Bahia
  • Hospital das Clinicas - UFMG — Belo Horizonte, Minas Gerais
  • Santa Casa de Misericordia — Belo Horizonte, Minas Gerais
  • Centro Mineiro de Pesquisa - CMIP — Juiz de Fora, Minas Gerais
  • Centro de Estudos em Terapias Inovadoras ? CETI — Curtiba, Paraná
  • Hospital das Clinicas - FMUSP Ribeirao Preto — Ribeirão Preto, São Paulo
  • Centro Multidisciplinar de Estudos Clínicos - CEMEC*X* — São Bernardo do Campo, São Paulo
  • Revmatologicky Ustav — Prague,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗