Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT00195663. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFα Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00195663
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 799 participants
Conditions and interventions
Conditions
Interventions
- Adalimumab Biological
- Methotrexate Drug
- Adalimumab placebo Biological
- Methotrexate placebo Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2000 (Type not available)
- Primary completion
- Apr 2004 (Actual)
- Completion
- Apr 2012 (Actual)
- Last update posted
- Jul 12, 2013
2000 – 2012
United States locations
- U.S. sites
- 31
- U.S. states
- 16
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site Reference ID/Investigator# 322 | Scottsdale | Arizona | 85260 | — |
| Site Ref # / Investigator 95957 | La Jolla | California | 92037 | — |
| Site Reference ID/Investigator# 429 | La Jolla | California | 92037 | — |
| Site Reference ID/Investigator# 2491 | Los Angeles | California | 90048 | — |
| Site Reference ID/Investigator# 2500 | Denver | Colorado | 80230 | — |
| Site Reference ID/Investigator# 762 | Aventura | Florida | 33180 | — |
| Site Reference ID/Investigator# 328 | Sarasota | Florida | 34239 | — |
| Site Reference ID/Investigator# 327 | Tampa | Florida | 33614 | — |
| Site Reference ID/Investigator# 325 | Zephyrhills | Florida | 33542 | — |
| Site Reference ID/Investigator# 302 | Rockford | Illinois | 61103 | — |
| Site Reference ID/Investigator# 319 | Cumberland | Maryland | 21502 | — |
| Site Ref # / Investigator 95960 | Hagerstown | Maryland | 21740 | — |
| Site Reference ID/Investigator# 326 | Wheaton | Maryland | 20902 | — |
| Site Reference ID/Investigator# 2533 | Worcester | Massachusetts | 01605-0000 | — |
| Site Reference ID/Investigator# 336 | Lincoln | Nebraska | 68516 | — |
| Site Reference ID/Investigator# 318 | Concord | New Hampshire | 03301 | — |
| Site Reference ID/Investigator# 488 | Durham | North Carolina | 27704 | — |
| Site Reference ID/Investigator# 314 | Dayton | Ohio | 45408 | — |
| Site Reference ID/Investigator# 761 | Oklahoma City | Oklahoma | 73103 | — |
| Site Reference ID/Investigator# 757 | Eugene | Oregon | 97401 | — |
| Site Reference ID/Investigator# 361 | Lake Oswego | Oregon | 97035 | — |
| Site Reference ID/Investigator# 316 | Bethlehem | Pennsylvania | 18015 | — |
| Site Reference ID/Investigator# 4649 | Duncansville | Pennsylvania | 16635 | — |
| Site Ref # / Investigator 96122 | Austin | Texas | 78705 | — |
| Site Reference ID/Investigator# 306 | Austin | Texas | 78705 | — |
| Site Reference ID/Investigator# 313 | Austin | Texas | 78705 | — |
| Site Reference ID/Investigator# 2437 | Dallas | Texas | 75231 | — |
| Site Reference ID/Investigator# 2532 | Houston | Texas | 77074 | — |
| Site Reference ID/Investigator# 758 | Houston | Texas | 77074 | — |
| Site Reference ID/Investigator# 321 | Spokane | Washington | 99204 | — |
| Site Reference ID/Investigator# 305 | Yakima | Washington | 98902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 92 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00195663, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 12, 2013 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00195663 live on ClinicalTrials.gov.