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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, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. 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.
Primary Outcome
American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global a
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 |
What the finished NCT00195663 record still lists
NCT00195663 is an interventional study that assigns participants to a tested intervention. The registered 799 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00195663's enrollment target sits among peer trials
799 428th of 2000 higher than 1,573 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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