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NCT01004432 · ClinicalTrials.gov registry record · Phase 3
Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)
A Phase 3 study of Arthritis and Arthritis, Rheumatoid, sponsored by Janssen Biotech.
- Completed
- Registry status
- Phase 3
- Development phase
- 433
- Enrollment target
- 20
- Study locations
NCT01004432 is a Phase 3 study of Arthritis and Arthritis, Rheumatoid that has completed, run by Janssen Biotech. The registered enrollment target is 433 participants, below the 4,501-participant average among 48 other Arthritis trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT01004432, a Phase 3 study of Arthritis and Arthritis, Rheumatoid, has completed, sponsored by Janssen Biotech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 433 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching participants from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.
Conditions Studied
Interventions
- DRUG Methotrexate (MTX)
- DRUG Placebo IV
- DRUG Placebo SC
- DRUG Golimumab 50 mg SC
- DRUG Golimumab 2 mg/kg IV
Study Locations (20)
California
- - Covina
- - Hemet
- - Loma Linda
- - Long Beach
- - Murrieta
- - Santa Maria
- - Santa Monica
- - Torrance
- - Van Nuys
- - Victorville
- - Whittier
Alabama
- - Birmingham
- - Huntsville
- - Tuscaloosa
Arizona
- - Mesa
- - Phoenix
Arkansas
- - Hot Springs
- - Little Rock
Connecticut
- - Bridgeport
- - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 433 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01004432
The ClinicalTrials.gov registry entry for NCT01004432 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 433 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,501-participant average among 48 other Arthritis trials with a reported enrollment target (90% lower). The listed sponsor is Janssen Biotech, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Arthritis appearing as the primary indexed condition, and to 5 interventions - of which Methotrexate (MTX) is the first listed.
NCT01004432 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01004432 about?
NCT01004432 is a clinical study titled "Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)". The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneou...
What is the current status of trial NCT01004432?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 433 participants. The study started on 2009-12. Estimated completion is 2013-10.
What conditions does trial NCT01004432 study?
This clinical trial studies the following conditions: Arthritis, Arthritis, Rheumatoid, Autoimmune Diseases.
What interventions are being tested in trial NCT01004432?
The interventions under investigation include: Methotrexate (MTX) (DRUG), Placebo IV (DRUG), Placebo SC (DRUG), Golimumab 50 mg SC (DRUG), Golimumab 2 mg/kg IV (DRUG).
Who is sponsoring clinical trial NCT01004432?
This trial is sponsored by Janssen Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01004432 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.