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NCT00195663 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis
A Phase 3 study of Early Rheumatoid Arthritis, sponsored by AbbVie (prior sponsor, Abbott).
- Completed
- Registry status
- Phase 3
- Development phase
- 799
- Enrollment target
- 20
- Study locations
NCT00195663: Completed Phase 3 study of Early Rheumatoid Arthritis, sponsored by AbbVie (prior sponsor, Abbott).
NCT00195663 is a Phase 3 study of Early Rheumatoid Arthritis that has completed, run by AbbVie (prior sponsor, Abbott). The registered enrollment target is 799 participants. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00195663, a Phase 3 study of Early Rheumatoid Arthritis, has completed, sponsored by AbbVie (prior sponsor, Abbott).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 799 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.
Conditions Studied
Interventions
- BIOLOGICAL Adalimumab
- DRUG Methotrexate
- BIOLOGICAL Adalimumab placebo
- DRUG Methotrexate placebo
Study Locations (20)
Florida
- Site Reference ID/Investigator# 762 - Aventura
- Site Reference ID/Investigator# 328 - Sarasota
- Site Reference ID/Investigator# 327 - Tampa
- Site Reference ID/Investigator# 325 - Zephyrhills
California
- Site Ref # / Investigator 95957 - La Jolla
- Site Reference ID/Investigator# 429 - La Jolla
- Site Reference ID/Investigator# 2491 - Los Angeles
Maryland
- Site Reference ID/Investigator# 319 - Cumberland
- Site Ref # / Investigator 95960 - Hagerstown
- Site Reference ID/Investigator# 326 - Wheaton
Arizona
- Site Reference ID/Investigator# 322 - Scottsdale
Colorado
- Site Reference ID/Investigator# 2500 - Denver
Illinois
- Site Reference ID/Investigator# 302 - Rockford
Massachusetts
- Site Reference ID/Investigator# 2533 - Worcester
Nebraska
- Site Reference ID/Investigator# 336 - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 799 participants |
| Start Date | 2000-12 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00195663
The ClinicalTrials.gov registry entry for NCT00195663 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 799 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie (prior sponsor, Abbott), which has 88 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Early Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions - of which Adalimumab is the first listed.
NCT00195663 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT00195663 about?
NCT00195663 is a clinical study titled "Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis". The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.
What is the current status of trial NCT00195663?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 799 participants. The study started on 2000-12. Estimated completion is 2012-04.
What conditions does trial NCT00195663 study?
This clinical trial studies the following conditions: Early Rheumatoid Arthritis.
What interventions are being tested in trial NCT00195663?
The interventions under investigation include: Adalimumab (BIOLOGICAL), Methotrexate (DRUG), Adalimumab placebo (BIOLOGICAL), Methotrexate placebo (DRUG).
Who is sponsoring clinical trial NCT00195663?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 88 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00195663 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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