Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01382940 · ClinicalTrials.gov registry record · Phase 4
A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis
A Phase 4 study of Rheumatoid Arthritis, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 4
- Development phase
- 351
- Enrollment target
- 20
- Study locations
NCT01382940: Completed Phase 4 study of Rheumatoid Arthritis, sponsored by Hoffmann-La Roche.
NCT01382940 is a Phase 4 study of Rheumatoid Arthritis that has completed, run by Hoffmann-La Roche. The registered enrollment target is 351 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01382940, a Phase 4 study of Rheumatoid Arthritis, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 351 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The primary criterion for assessing safety of the faster infusion was the incidence of infusion related reaction (IRRs). IRRs were adverse events (AEs) that occurred within 24 hours of beginning infusion that were among a pre-specified list of preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA). "Incidence" is defined as the percentage of participants experiencing an IRR.
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
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2011-07-26 |
| Est. Completion | 2013-01-06 |
| Phase | Phase 4 |
What the finished NCT01382940 record still lists
NCT01382940 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (93% lower).
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.
NCT01382940 names 20 study sites across 6 states, led by California, Arizona, Alabama.
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.
What interventions are being tested in trial NCT01382940?
The interventions under investigation include: methylprednisolone (DRUG), rituximab (DRUG), methotrexate (DRUG), acetaminophen (DRUG), antihistamine (DRUG).
Who is sponsoring clinical trial NCT01382940?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Rheumatoid Arthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01382940's enrollment target sits among peer trials
351 53rd of 197 higher than 145 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
NSAIDs vs. Coxibs in the Presence of Aspirin
RECRUITING · Phase 4
-
Improving Bone Health Among Rheumatoid Arthritis (RA) Patients on Chronic Glucocorticoids
COMPLETED · Phase 4
-
Milnacipran for Treatment of Pain in Older Adults With Rheumatoid Arthritis
COMPLETED · Phase 4
-
A Study of Baricitinib in Participants With Rheumatoid Arthritis
COMPLETED · Phase 4
-
IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA
COMPLETED · Phase 4
-
Centocor Microarray Study of Patients
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06241456 · 351 participants · Phase 1
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
- NCT06576726 · 351 participants
Sensorimotor and Psychosocial Trajectories in Adolescents With Tic Disorder
- NCT07043400 · 351 participants · Phase 3
A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- NCT07261423 · 351 participants · NA
Pollution Intervention to Impact Kids Asthma Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI