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Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis
NCT00195663 · View on ClinicalTrials.gov ↗
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 |
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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. 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 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 16 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 Early Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions — of which Adalimumab 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: NCT00195663 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, Maryland. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00195663?
The interventions under investigation include: Adalimumab (BIOLOGICAL), Methotrexate (DRUG), Adalimumab placebo (BIOLOGICAL), Methotrexate placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00195663?
This trial is sponsored by AbbVie (prior sponsor, Abbott), which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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