Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
NCT00913458
Last updated date
ABOUT THIS STUDY
Study to evaluate whether there is sustained remission and productivity in subjects with
early rheumatoid arthritis started on etanercept plus methotrexate treatment.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Rheumatoid Arthritis, Rheumatoid Arthritis, Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Diagnosis of early rheumatoid arthritis.
- Methotrexate (MTX) naive.
- Active early rheumatoid arthritis at the time of enrollment.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF)
inhibitors, or other biologic agents.
- Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), within
4 weeks before baseline.
- Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at
baseline.
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Active Rheumatoid Arthritis, Rheumatoid Arthritis, Rheumatoid ArthritisStudy Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
NCT00913458
- Lyon,
- Montpellier Cedex 05,
- Paris Cedex 13,
- Paris Cedex 14,
- Paris,
- Strasbourg Cedex,
- Toulouse Cedex 9,
- Vogelsang, Gommern
- Elmshorn,
- Halle,
- Halle,
- Hamburg-Altona,
- Hamburg,
- Ludwigsfelde,
- Muenchen,
- Osnabrueck,
- Rostock,
- Wuerzburg,
- Zerbst,
- Dublin,
- Pavia,
- Pisa,
- Monaco,
- Amsterdam, Noord Holland
- Haarlem,
- Heerlen,
- Bydgoszczy,
- Poznan,
- Torun,
- Ustron,
- Warsawa,
- Warszawa,
- Wroclaw,
- Zyrardow,
- Doha,
- Bucharest,
- Bucuresti,
- Bucuresti,
- Bucuresti,
- Bucuresti,
- Targu Mures,
- Yaroslavl,
- Oviedo, Asturias
- Barcelona,
- Barcelona,
- La Coruna,
- Madrid,
- Valencia,
- St. Gallen, SG
- Chur,
- Lausanne,
- Wigan, Lancaster
- Harrogate, North Yorkshire
- Dudley, West Midlands
- Leeds, West Yorkshire
- London,
- Manchester,
- Newcastle Upon Tyne,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis | |||
| Official Title ICMJE | A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate | |||
| Brief Summary | Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: etanercept
Other Name: Enbrel | |||
| Study Arms ICMJE | Experimental: 1
etanercept + methotrexate; etanercept + methotrexate Intervention: Drug: etanercept | |||
| Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 306 | |||
| Original Estimated Enrollment ICMJE | 300 | |||
| Actual Study Completion Date ICMJE | December 2012 | |||
| Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | France, Germany, Ireland, Italy, Monaco, Netherlands, Poland, Qatar, Romania, Russian Federation, Spain, Switzerland, United Kingdom | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00913458 | |||
| Other Study ID Numbers ICMJE | 0881X1-4524 B1801020 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | July 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||