Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
NCT00487825 · View on ClinicalTrials.gov ↗
Study Summary
This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Methotrexate (MTX)
- DRUG Canakinumab (investigational)
Study Locations (20)
Florida
- Jacksonville Center for Clinical Research (Dr. Steven Mathews) — Jacksonville
- Center for Arthritis and Rheumatic Diseases (Dr. Michael Weitz) — South Miami
- West Broward Rheumatology Associates, Incorporated (Dr. Elias Halpert) — Tamarac
Texas
- MetaClin Research, Incorporated (Dr. Paul Pickrell) — Austin
- John M. Joseph, MD (Dr. John Joseph) — Carlton
- Southwest Rheumatology, P.A. (Dr. Atul Singhal) — Mesquite
Other
- Novartis Investigative site — Brussels
- Novartis investigative site — Nuremberg
- Novartis investigative site — Milan
Alabama
- Rheumatology Associates of Northern Alabama (Dr. William Shergy) — Huntsville
- Clinic for Rheumatic Diseases (Dr. Richard Jones, III) — Tuscaloosa
Arizona
- Arizona Arthritis and Rheumatology Research (Dr. Paul Caldron) — Paradise Valley
Illinois
- Rockford Orthopedic Associates (Dr. Richard Olson) — Rockford
Iowa
- Mercy Arthritis and Osteoporosis Center (Dr. Alan Braun) — Urbandale
Missouri
- Clayton Medical Research (Dr. Iri Don) — Richmond Heights
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00487825
The ClinicalTrials.gov registry entry for NCT00487825 describes a study currently listed as completed. It is categorized as Phase 2, 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 78 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 60 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 3 interventions — of which Placebo 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: NCT00487825 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Texas, Other. 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 NCT00487825 about?
NCT00487825 is a clinical study titled "Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis". This study was intended to evaluate the safety and efficacy of intravenous (IV) ACZ885 and oral methotrexate (MTX) therapy in patients with early rheumatoid arthritis (RA)
What is the current status of trial NCT00487825?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2007-03. Estimated completion is 2008-12.
What conditions does trial NCT00487825 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 NCT00487825?
The interventions under investigation include: Placebo (DRUG), Methotrexate (MTX) (DRUG), Canakinumab (investigational) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00487825?
This trial is sponsored by Novartis, which has 60 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00487825 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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