Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)
NCT01004432 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, 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 433 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Biotech, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT01004432 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Alabama, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01004432?
This trial is sponsored by Janssen Biotech, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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