ClinicalTrials.gov record
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)
ClinicalTrials.gov ID: NCT00476996
Public ClinicalTrials.gov record NCT00476996. 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 Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.
Study identification
- NCT ID
- NCT00476996
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 836 participants
Conditions and interventions
Conditions
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
- May 15, 2007 (Actual)
- Primary completion
- Jan 21, 2010 (Actual)
- Completion
- May 14, 2018 (Actual)
- Last update posted
- Aug 12, 2019
2007 – 2018
United States locations
- U.S. sites
- 144
- U.S. states
- 39
- U.S. cities
- 119
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group; Llc, Central | Anniston | Alabama | 36207 | — |
| Rheumatology Associates | Birmingham | Alabama | 35205 | — |
| Rheumatology Associates of North Alabama | Huntsville | Alabama | 35801 | — |
| Arizona Arthritis & Rheumatology Research, Pllc | Mesa | Arizona | 85202 | — |
| Arthrocare, Arthritis Care and Research, P.C. | Mesa | Arizona | 85208 | — |
| Catalina Pointe Clinical Research, Inc. | Tucson | Arizona | 85704 | — |
| Uni of Arizona Health Science Center; Dept of Rheumatology/Immunology | Tucson | Arizona | 85724 | — |
| CHI St. Vincent Medical Group Hot Springs | Hot Springs | Arkansas | 71913 | — |
| Little Rock Diagnostic Clinic | Little Rock | Arkansas | 72205 | — |
| Allergy & Rheumatology Centre | La Jolla | California | 92037 | — |
| Private Practice | Long Beach | California | 90808 | — |
| Valerius Medical Group & Research Ctr of Greater Long Beach | Los Alamitos | California | 90720 | — |
| Uni of Southern California School of Medicine | Los Angeles | California | 90033 | — |
| Pacific Arthritis Care Center | Los Angeles | California | 90045 | — |
| Stanford Uni Medical Center; Divison of Rheumatology | Palo Alto | California | 94304 | — |
| Ucsd, Dept of Medicine; Rheumatology | San Diego | California | 92093 | — |
| San Diego Arthritis Med Clnc | San Diego | California | 92108 | — |
| East Bay Rheumatology | San Leandro | California | 94578 | — |
| Arthritis Treatment Center of South Bay | Torrance | California | 90505 | — |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs | Colorado Springs | Colorado | 80920 | — |
| Arthritis & Osteoporosis Center P.C. | Camden | Connecticut | 06510 | — |
| New England Research Associates | Trumbull | Connecticut | 06611 | — |
| Rheumatolgy Consultants of Deleware | Lewes | Delaware | 19958 | — |
| Javed Rheumatology Associates, Inc. | Newark | Delaware | 19713 | — |
| Arthritis & Rheumatism; Disease Specialities | Aventura | Florida | 33180 | — |
| Jacksonville Center For Clinical Research | Jacksonville | Florida | 32216 | — |
| Arthritis Center Palm Harbor | Palm Harbor | Florida | 34684 | — |
| Arthritis Rsrch of Florida, Inc. | Palm Harbor | Florida | 34684 | — |
| Sarasota Arthritis Center; Research Dept | Sarasota | Florida | 34239 | — |
| Center For Arthritis; Research Dept | South Miami | Florida | 33143 | — |
| SW Florida Clinical Research | Tampa | Florida | 33609 | — |
| Tampa General Hospital; Rheumatology Research Dept | Tampa | Florida | 33612 | — |
| Burnette & Silverfield, MDS | Tampa | Florida | 33614 | — |
| Florida Medical Center | Zephyrhills | Florida | 33540 | — |
| Atlanta Center For Clinical Research. | Atlanta | Georgia | 30342 | — |
| Csi Research, Inc. | Cumming | Georgia | 30041 | — |
| Marietta Rheumatology Associates, Pc | Marietta | Georgia | 30060 | — |
| Intermountain Orthopaedics | Boise | Idaho | 83702 | — |
| Coeur D'Alene Arthritis Clinic | Coeur d'Alene | Idaho | 83814 | — |
| Idaho Arthritis Center | Meridian | Idaho | 83642 | — |
| Uni of Chicago | Chicago | Illinois | 60637 | — |
| Evanston Northwestern Healthcare; Rheumatology | Evanston | Illinois | 60201 | — |
| Quad City Rheumatology, Sc | Moline | Illinois | 61265 | — |
| Illinois Bone & Joint Inst. | Morton Grove | Illinois | 60053 | — |
| Springfield Clinic | Springfield | Illinois | 62703 | — |
| Iu Outpatient Clinical Research Facility | Indianapolis | Indiana | 46202-5149 | — |
| Diagnostic Rheumatology & Research | Indianapolis | Indiana | 46227 | — |
| Medical Specialists Clinical Research Center | Munster | Indiana | 46321 | — |
| Physician'S Clinic of Iowa | Cedar Rapids | Iowa | 52401 | — |
| Uni of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Center For Arthritis & Osteoporosis | Elizabethtown | Kentucky | 42701 | — |
| Bluegrass Comm Research, Inc. | Lexington | Kentucky | 40515 | — |
| Kentuckiana Center For Better Bone & Joint Healthx | Louisville | Kentucky | 40202 | — |
| Baton Rouge Clinic, Amc | Baton Rouge | Louisiana | 70808 | — |
| Johns Hopkins University; Department of Rheumatology | Baltimore | Maryland | 21224 | — |
| Center For Rheumatology & Bone Research | Wheaton | Maryland | 20902 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | — |
| Clinsite;Research Division of Integrated Health Associates | Ann Arbor | Michigan | 48106 | — |
| Rheumatology, P.C.; Medical Arts Building | Kalamazoo | Michigan | 49009 | — |
| Borgess Research Institute | Kalamazoo | Michigan | 49048 | — |
| Fiechtner Research Inc | Lansing | Michigan | 48910 | — |
| Office of Andrew Sulich, Md | Saint Clair Shores | Michigan | 48080 | — |
| St Luke's Whiteside Research | Duluth | Minnesota | 55805 | — |
| St. Mary'S Duluth Clinic Health System; Rheumatology Dept | Duluth | Minnesota | 55805 | — |
| St. Paul Rheumatology | Eagan | Minnesota | 55121 | — |
| Park Nicollet Inst. ; Rtrc | Minneapolis | Minnesota | 55416 | — |
| Jackson Arthritis Clinic | Flowood | Mississippi | 39232 | — |
| North Mississippi Medical Ctr; Internal Medicine Associates | Tupelo | Mississippi | 38802 | — |
| David S Rosenberg | Florissant | Missouri | 63031 | — |
| St. John'S Health System Inc.; St. John'S Medical Research | Springfield | Missouri | 65807 | — |
| Clayton Medical Research | St Louis | Missouri | 63117 | — |
| Physicians Group, LC DBA Rheumatology & Internal Medicine Associates | St Louis | Missouri | 63131 | — |
| Arthritis Consultants | St Louis | Missouri | 63141 | — |
| Westroads Medical Group | Omaha | Nebraska | 68114 | — |
| Seacoast Arthritis and Osteoporosis Center | Dover | New Hampshire | 03820 | — |
| Nashua Rheumatology - Foundation Medical Partners | Nashua | New Hampshire | 03060 | — |
| Mark Fisher Md, Facr, Llc | Haddon Heights | New Jersey | 08035 | — |
| Arthritis Rheumatic & Back Disease Associates | Voorhees Township | New Jersey | 08043 | — |
| The Center of Rheumatology | Albany | New York | 12206 | — |
| Arthritis & Osteoporosis Center | Brooklyn | New York | 11201 | — |
| Southern Tier Arthritis & Rheumatism | Olean | New York | 14760 | — |
| Aair Research Center | Rochester | New York | 14618 | — |
| Andrew Porges Pc | Roslyn | New York | 11576 | — |
| Rheumatology Associates of Long Island | Smithtown | New York | 11787 | — |
| Asheville Arthritis & Osteoporosis Center, PA | Asheville | North Carolina | 28803 | — |
| Arthritis Associates | Belmont | North Carolina | 28012 | — |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | — |
| Carolina Bone & Joint P.A. | Charlotte | North Carolina | 28210 | — |
| Physicians East Pa | Greenville | North Carolina | 27834 | — |
| St. Alexius Medical Center; Arthritis Clinic | Bismarck | North Dakota | 58501 | — |
| Deaconess Arthritis Center; Rheumatic Disease Study Group | Cincinnati | Ohio | 45219 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Stat Research, Inc | Dayton | Ohio | 45402 | — |
| David Mandel Inc | Mayfield | Ohio | 44143 | — |
| Paramount Medical Research | Middleburg Heights | Ohio | 44130 | — |
| Health Research of Oklahoma, Llc | Oklahoma City | Oklahoma | 73103 | — |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | — |
| Oklahoma Center For Arthritis Therapy & Research | Tulsa | Oklahoma | 74104 | — |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | — |
| Bend Memorial Clinic | Bend | Oregon | 97701 | — |
| Pro Research | Eugene | Oregon | 97401 | — |
| Portland Rheumatology Clinic Llc | Lake Oswego | Oregon | 97035 | — |
| Providence Arthritis Center | Portland | Oregon | 97213 | — |
| East Penn Rheumatology Associates, Pc | Bethlehem | Pennsylvania | 18015 | — |
| Arthritis Associates | Erie | Pennsylvania | 16508 | — |
| Rheumatology Associates of NW Pa | Erie | Pennsylvania | 16508 | — |
| Arthritis Group | Philadelphia | Pennsylvania | 19152 | — |
| Advanced Rheumatology & Arthritis Research Center | Wexford | Pennsylvania | 15090 | — |
| Clinical Research Center of Reading | Wyomissing | Pennsylvania | 19610 | — |
| Low Country Research Center | Charleston | South Carolina | 29406 | — |
| Palmetto Clinical Trial Services, LLC | Fountain Inn | South Carolina | 29644 | — |
| Unifour Medical Research Associates | Hickory Grove | South Carolina | 28602 | — |
| Medical Uni of South Carolina | North Charleston | South Carolina | 29425 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Rheumatology Consultants | Knoxville | Tennessee | 37909 | — |
| Arthritis Group | Memphis | Tennessee | 38104 | — |
| Ramesh Gupta - PP | Memphis | Tennessee | 38119 | — |
| Aamr Research Clinic | Amarillo | Texas | 79106 | — |
| Amarillo Center For Clinical Research | Amarillo | Texas | 79124 | — |
| Austin Rheumatology Research | Austin | Texas | 78705 | — |
| Walter F. Chase, Md, Pa | Austin | Texas | 78705 | — |
| Arthritis Care & Diagnostic Center | Dallas | Texas | 75231-4406 | — |
| Arthritis Care and Research Centre | Dallas | Texas | 75231 | — |
| Metroplex Clinical Research | Dallas | Texas | 75231 | — |
| Arthritis Centers of Texas | Dallas | Texas | 75246 | — |
| Uni of Texas Southwestern Medical Center; Internal Medicine | Dallas | Texas | 75390 | — |
| Arthritis & Osteoporosis Associates, LLP | Lubbock | Texas | 79424 | — |
| Southwest Rheumatology | Mesquite | Texas | 75150 | — |
| Radiant Research | San Antonio | Texas | 78217 | — |
| Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases | San Antonio | Texas | 78217 | — |
| Texas Research Center | Sugar Land | Texas | 77479 | — |
| Uni of Utah Medical Center | Salt Lake City | Utah | 84132 | — |
| Arthritis Clinic of Northern Virginia | Arlington | Virginia | 22205 | — |
| Sentara Medical Group | Norfolk | Virginia | 23507 | — |
| Seattle Rheumatology Associates | Seattle | Washington | 98104 | — |
| Arthritis Northwest, Spokane | Spokane | Washington | 99204 | — |
| Office of George Krick, Md | Tacoma | Washington | 98405 | — |
| Tacoma Center For Arthritis Research | Tacoma | Washington | 98405 | — |
| Vancouver Clinic; Research Dept | Vancouver | Washington | 98664 | — |
| Clinical Trials Northwest | Yakima | Washington | 98902 | — |
| Rheumatic Disease Center | Glendale | Wisconsin | 53217 | — |
| Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med | Onalaska | Wisconsin | 54605 | — |
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 122 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00476996, 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 Aug 12, 2019 · Synced Oct 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00476996 live on ClinicalTrials.gov.