A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy
Public ClinicalTrials.gov record NCT00316771. 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.
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Official title
A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
Study identification
- NCT ID
- NCT00316771
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 374 participants
Conditions and interventions
Conditions
Interventions
- P38 Inhibitor (4) 150mg Drug
- P38 Inhibitor (4) 25mg Drug
- P38 Inhibitor (4) 300mg Drug
- P38 Inhibitor (4) 50mg Drug
- P38 Inhibitor (4) 75mg Drug
- Placebo Drug
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
- Nov 2005 (Type not available)
- Primary completion
- Mar 2008 (Actual)
- Completion
- Mar 2008 (Actual)
- Last update posted
- Nov 2, 2016
2005 – 2008
United States locations
- U.S. sites
- 48
- U.S. states
- 25
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35242 | — |
| Not listed | Paradise Valley | Arizona | 85253 | — |
| Not listed | Tucson | Arizona | 85704 | — |
| Not listed | Tucson | Arizona | 85711 | — |
| Not listed | Tucson | Arizona | 85712 | — |
| Not listed | Escondido | California | 92025 | — |
| Not listed | Fair Oaks | California | 95628 | — |
| Not listed | Loma Linda | California | 92357 | — |
| Not listed | Riverside | California | 92501 | — |
| Not listed | Upland | California | 91786 | — |
| Not listed | Gainesville | Florida | 32607 | — |
| Not listed | Ocala | Florida | 34474 | — |
| Not listed | Ormond Beach | Florida | 32174 | — |
| Not listed | Sarasota | Florida | 34232 | — |
| Not listed | Tamarac | Florida | 33321 | — |
| Not listed | Atlanta | Georgia | 30303 | — |
| Not listed | Atlanta | Georgia | 30342 | — |
| Not listed | Macon | Georgia | 31210 | — |
| Not listed | Nampa | Idaho | 83687 | — |
| Not listed | Munster | Indiana | 46321 | — |
| Not listed | South Bend | Indiana | 46601 | — |
| Not listed | Wichita | Kansas | 67207 | — |
| Not listed | Worcester | Massachusetts | 01610 | — |
| Not listed | Traverse City | Michigan | 49684 | — |
| Not listed | Omaha | Nebraska | 68114 | — |
| Not listed | Toms River | New Jersey | 08755 | — |
| Not listed | Albuquerque | New Mexico | 87102 | — |
| Not listed | New Hartford | New York | 13413 | — |
| Not listed | Rochester | New York | 14618 | — |
| Not listed | Belmont | North Carolina | 28012 | — |
| Not listed | North Fargo | North Dakota | 58122 | — |
| Not listed | Tulsa | Oklahoma | 74136 | — |
| Not listed | Bend | Oregon | 97701 | — |
| Not listed | Camp Hill | Pennsylvania | 17011 | — |
| Not listed | Pittsburgh | Pennsylvania | 15237 | — |
| Not listed | Wilkes-Barre | Pennsylvania | 18711 | — |
| Not listed | Sioux Falls | South Dakota | 57105 | — |
| Not listed | Jackson | Tennessee | 38305 | — |
| Not listed | Knoxville | Tennessee | 37909 | — |
| Not listed | Memphis | Tennessee | 38104 | — |
| Not listed | Amarillo | Texas | 79106 | — |
| Not listed | Bryan | Texas | 77802 | — |
| Not listed | Carrollton | Texas | 75007 | — |
| Not listed | Lubbock | Texas | 79424 | — |
| Not listed | Norfolk | Virginia | 23502 | — |
| Not listed | Everett | Washington | 98201 | — |
| Not listed | Seattle | Washington | 98133 | — |
| Not listed | Monroe | Wisconsin | 53566 | — |
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 66 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00316771, 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 Nov 2, 2016 · Synced Nov 8, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00316771 live on ClinicalTrials.gov.