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COMPLETED Phase 4

A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis

NCT01382940 · View on ClinicalTrials.gov ↗

Study Summary

This study was designed to evaluate the safety of administering rituximab at a more rapid infusion rate in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to biopharmaceuticals that treat diseases by interfering with tumor necrosis factor (anti-TNF therapies), and were receiving methotrexate therapy for more than eight weeks.

Conditions Studied

Interventions

  • DRUG methylprednisolone
  • DRUG rituximab
  • DRUG methotrexate
  • DRUG acetaminophen
  • DRUG antihistamine

Study Locations (20)

California

  • Medvin Clinical Research — Covina
  • Triwest Research Associates — La Mesa
  • Medvin Clinical Research — Los Angeles
  • Brigid Freyne-Private Practice; Internal Medicine, Rheum — Murrieta
  • Desert Medical Advances; Rheumatology — Palm Desert
  • San Diego Arthritis Med Clnc — San Diego
  • Pacific Arthritis Ctr Med Grp — Santa Maria
  • Inland Rheumatology; Clinical Trials, Inc. — Upland
  • Medvin Clinical Research — Whittier

Arizona

  • ArthroCare, Arthritis Care; and Research P.C. — Gilbert
  • Valley Arthritis Care — Phoenix
  • Catalina Pointe Rheumatology — Tucson

Alabama

  • Uni Of Alabama,Birmingham; Medicine - Rheumatology — Birmingham
  • Clnical & Translational Reseach Center for Alabama, PC — Tuscaloosa

Colorado

  • Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs — Colorado Springs
  • Denver Arthritis Clinic — Denver

Connecticut

  • Rheum & Internal Med Assoc-Bri — Bridgeport
  • Arthritis & Osteoporosis Center Pc — Hamden

Delaware

  • Rheumatolgy Consultants of Deleware — Lewes
  • Javed Rheumatology Associates, Inc. — Newark

Trial Details

FieldValue
Enrollment Target 351 participants
Start Date 2011-07-26
Est. Completion 2013-01-06
Phase Phase 4

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01382940

The ClinicalTrials.gov registry entry for NCT01382940 describes a study currently listed as completed. It is categorized as Phase 4, 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 351 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 Rheumatoid Arthritis appearing as the primary indexed condition, and to 5 interventions — of which methylprednisolone 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: NCT01382940 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Alabama. 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 NCT01382940 about?

NCT01382940 is a clinical study titled "A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis". This study was designed to evaluate the safety of administering rituximab at a more rapid infusion rate in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to biopharmaceuticals that treat diseases by interfering with tumor necrosis factor (anti-TNF therapies...

What is the current status of trial NCT01382940?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 351 participants. The study started on 2011-07-26. Estimated completion is 2013-01-06.

What conditions does trial NCT01382940 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01382940?

The interventions under investigation include: methylprednisolone (DRUG), rituximab (DRUG), methotrexate (DRUG), acetaminophen (DRUG), antihistamine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01382940?

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 NCT01382940 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. 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