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NCT00487825 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis
A Phase 2 study of Rheumatoid Arthritis, sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 20
- Study locations
NCT00487825: Completed Phase 2 study of Rheumatoid Arthritis, sponsored by Novartis.
NCT00487825 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by Novartis. The registered enrollment target is 78 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00487825, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 20
- Study locations
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)
Primary Outcome
A patient was considered as improved according to the ACR50 criteria if she/he had at least a 50 % improvement in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures: * Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm) * Patient's global assessment of disease activity (VAS 100 mm) * Physician's global assessment of disease activity (VAS 100 mm) * Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score) * Acute phase re
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 |
What the finished NCT00487825 record still lists
NCT00487825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (98% lower).
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.
NCT00487825 names 20 study sites across 13 states, led by Florida, Texas, Other.
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.
What interventions are being tested in trial NCT00487825?
The interventions under investigation include: Placebo (DRUG), Methotrexate (MTX) (DRUG), Canakinumab (investigational) (DRUG).
Who is sponsoring clinical trial NCT00487825?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00487825's enrollment target sits among peer trials
78 124th of 197 higher than 74 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.
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