ClinicalTrials.gov record
A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX
ClinicalTrials.gov ID: NCT01855789
Public ClinicalTrials.gov record NCT01855789. 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 Trial Assessing the Impact of Methotrexate Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose orally in an open-label manner for 24 weeks. Participants with a disease activity score based on 28 joints (DAS28) less than or equal to (\</=) 3.2 at Week 24, will be randomized to either continue receiving a stable dose of MTX or to switch to matching placebo up to Week 52. Participants without a DAS28 score \</=3.2 at Week 24, will continue the same treatment in a non-randomized open-label manner up to Week 52.
Study identification
- NCT ID
- NCT01855789
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 718 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
- Nov 6, 2013
- Primary completion
- Oct 13, 2016
- Completion
- Oct 13, 2016
- Last update posted
- Dec 25, 2017
2013 – 2016
United States locations
- U.S. sites
- 155
- U.S. states
- 37
- U.S. cities
- 129
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group; Llc, Central | Anniston | Alabama | 36207 | — |
| Uni Of Alabama,Birmingham; Medicine - Rheumatology | Birmingham | Alabama | 35294 | — |
| Rheumatology Associates of North Alabama | Huntsville | Alabama | 35801 | — |
| Clnical & Translational Reseach Center for Alabama, PC | Tuscaloosa | Alabama | 35406 | — |
| Arizona Arthritis & Rheumatology Associates, P.C. | Glendale | Arizona | 85306 | — |
| Arizona Arthritis & Rheumatology Research, Pllc | Mesa | Arizona | 85202 | — |
| Arizona Arthritis and Rheuma | Mesa | Arizona | 85202 | — |
| Valley Arthritis Care | Phoenix | Arizona | 85027 | — |
| Advanced Arthritis Care & Research | Scottsdale | Arizona | 85258 | — |
| Fort Smith Rheumatology, PC | Fort Smith | Arkansas | 72903 | — |
| CHI St. Vincent Medical Group Hot Springs | Hot Springs | Arkansas | 71913 | — |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | — |
| Little Rock Diagnostic Clinic | Little Rock | Arkansas | 72205 | — |
| Medvin Clinical Research | Covina | California | 91723 | — |
| TriWest Research Associates, LLC | El Cajon | California | 92020 | — |
| St. Jude Hospital Yorba Linda DBA St. Joseph | Fullerton | California | 92835 | — |
| CV Mehta MD Medical Corp | Hemet | California | 92543 | — |
| Valerius Medical Group | Los Alamitos | California | 90720 | — |
| NRC Research Institute | Orange | California | 92868 | — |
| San Diego Arthritis Med Clnc | San Diego | California | 92108 | — |
| C Michael Neuwelt MD Inc | San Leandro | California | 94578 | — |
| Inland Rheumatology; Clinical Trials, Inc. | Upland | California | 91785-1141 | — |
| Medvin Clinical Research | Whittier | California | 90606 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs | Colorado Springs | Colorado | 80920 | — |
| Denver Arthritis Clinic | Denver | Colorado | 80230-7127 | — |
| Joao Nascimento | Bridgeport | Connecticut | 06606 | — |
| Clinical Research Center of Ct/Ny | Danbury | Connecticut | 06810 | — |
| Arthritis & Osteoporosis Center Pc | Hamden | Connecticut | 06518 | — |
| 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 | — |
| Robert Levin, Md; Research Dept | Dunedin | Florida | 34698 | — |
| Suncoast Research Group LLC | Miami | Florida | 33135 | — |
| South Coast Research Center, Inc. | Miami | Florida | 33136 | — |
| Precision Research Organization | Miami Lakes | Florida | 33016 | — |
| Jeffrey Alper M.D Research | Naples | Florida | 34102 | — |
| Rheumatology Associates of Central Florida | Orlando | Florida | 32806 | — |
| Arthritis and Rheumatology Clinic | Orlando | Florida | 32836 | — |
| Arthritis Center Palm Harbor | Palm Harbor | Florida | 34684 | — |
| Arthritis Rsrch of Florida, Inc. | Palm Harbor | Florida | 34684 | — |
| Sarasota Arthritis Res Center | Sarasota | Florida | 34239 | — |
| Pinellas Medical Research - Allegry & Rheumatology Associates, LLC | St. Petersburg | Florida | 33708 | — |
| West Broward Rheumatology Associates, Inc. | Tamarac | Florida | 33321 | — |
| McIlwain Medical Group | Tampa | Florida | 33613 | — |
| Burnette & Silverfield, MDS | Tampa | Florida | 33614 | — |
| Advanced Clinical Research of Orlando, Inc. | Winter Garden | Florida | 34787 | — |
| North Georgia Rheumatology | Duluth | Georgia | 30096 | — |
| Arthritis Center of North Georgia | Gainesville | Georgia | 30501 | — |
| North Georgia Rheumatology Group, PC | Lawrenceville | Georgia | 30046 | — |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | — |
| Springfield Clinic | Springfield | Illinois | 62703 | — |
| Indiana Uni Medical Center | Indianapolis | Indiana | 46202 | — |
| Diagnostic Rheumatology & Research | Indianapolis | Indiana | 46227 | — |
| Kansas City Internal Medicine | Overland Park | Kansas | 66209 | — |
| Bluegrass Comm Research, Inc. | Lexington | Kentucky | 40515 | — |
| Arthritis & Diabetes Clinic, Inc | Monroe | Louisiana | 71203 | — |
| Klein & Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | — |
| New England Medical Center; Dept. of Medicine, Div. of Rheumatology | Boston | Massachusetts | 02111 | — |
| Phase Iii Clinical Research | Fall River | Massachusetts | 02720 | — |
| Mansfield Medical Center | Mansfield | Massachusetts | 02048 | — |
| Reliant Medical Group, Inc; Rheumatology | Worcester | Massachusetts | 01605 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01605 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | — |
| Advanced Rheumatology, PC | Lansing | Michigan | 48910 | — |
| Fiechtner Research Inc | Lansing | Michigan | 48910 | — |
| Nisus Research/Northern Michigan Hospital | Petoskey | Michigan | 49770 | — |
| Shores Rheumatology | Saint Clair Shores | Michigan | 48081 | — |
| St. Luke's Hospital Association of Duluth | Duluth | Minnesota | 55805 | — |
| St. Paul Rheumatology | Eagan | Minnesota | 55121 | — |
| Arthritis and Osteoporosis; Treatment and Research Center | Flowood | Mississippi | 39232 | — |
| Jackson Arthritis Clinic | Flowood | Mississippi | 39232 | — |
| David S Rosenberg | Florissant | Missouri | 63031 | — |
| Clinical Research Consultants,LLC | Kansas City | Missouri | 64111 | — |
| Clayton Medical Research | St Louis | Missouri | 63117 | — |
| Arthritis Consultants | St Louis | Missouri | 63141 | — |
| G. T. Kelly, MD | Las Vegas | Nevada | 89128 | — |
| Rheumatology Research Group | Lebanon | New Hampshire | 03756 | — |
| Nashua Rheumatology - Foundation Medical Partners | Nashua | New Hampshire | 03060 | — |
| Arthritis and Osteoporosis Associates | Manalapan | New Jersey | 07726 | — |
| Atlantic Coast Rheumatology | Toms River | New Jersey | 08755 | — |
| Ocean Rheumatology | Toms River | New Jersey | 08775 | — |
| Arthritis Rheumatic & Back Disease Associates | Voorhees Township | New Jersey | 08043 | — |
| Cooper Cancer Institute | Voorhees Township | New Jersey | 08043 | — |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | — |
| Arthritis and Osteoporosis Associates of New Mexico | Las Cruces | New Mexico | 88011 | — |
| The Center for Rheumatology | Albany | New York | 12203 | — |
| Arthritis & Osteoporosis Center | Brooklyn | New York | 11201 | — |
| Manhasset Rheumatology | Manhasset | New York | 11030 | — |
| Manhattan Medical Reserach | New York | New York | 10016 | — |
| Buffalo Rheumatology Associates | Orchard Park | New York | 14127 | — |
| Office of Premier Chatpar Md | Plainview | New York | 11803 | — |
| Rheumatology Associates of Long Island | Smithtown | New York | 11787 | — |
| Arthritis Health Associates | Syracuse | New York | 13210 | — |
| Asheville Arthritis & Osteoporosis Center, PA | Asheville | North Carolina | 28803 | — |
| Carolina Bone & Joint P.A. | Charlotte | North Carolina | 28210 | — |
| Triangle Orthopaedics Associates, P.A. | Durham | North Carolina | 27704 | — |
| Medication Management | Greensboro | North Carolina | 27408 | — |
| PMG Research of Hickory LLC | Hickory | North Carolina | 28602 | — |
| Cape Fear Arthritis Care | Leland | North Carolina | 28451 | — |
| Shanahan Rheumatology & Immunology, PLLC | Raleigh | North Carolina | 27617 | — |
| St. Alexius Medical Center; Arthritis Clinic | Bismarck | North Dakota | 58501 | — |
| Odyssey Research Services; Main Medical Building | Bismarck | North Dakota | 58507 | — |
| Crystal Arthritis Center, Inc. | Akron | Ohio | 44333 | — |
| Cincinnati Rheumatic Disease Study Group | Cincinnati | Ohio | 45219 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44109 | — |
| Ohio State University; Rheumatology; Immun/Rheum | Columbus | Ohio | 43203 | — |
| Columbus Arthritis Center | Columbus | Ohio | 43215 | — |
| STAT Research Inc | Dayton | Ohio | 45417 | — |
| Paramount Medical Research | Middleburg Heights | Ohio | 44130 | — |
| Clinical Research Source, Inc. | Toledo | Ohio | 43606 | — |
| Arthritis Care Center Oklahoma | Ardmore | Oklahoma | 73401 | — |
| Arthritis and Rheumatology; Center of Oklahoma PLLC | Oklahoma City | Oklahoma | 73103 | — |
| Health Research of Oklahoma, Llc | Oklahoma City | Oklahoma | 73103 | — |
| Lynn Health Science Inst. | Oklahoma City | Oklahoma | 73112 | — |
| Oklahoma Center For Arthritis Therapy & Research | Tulsa | Oklahoma | 74104 | — |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | — |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Arthritis Associates | Erie | Pennsylvania | 16508 | — |
| Arthritis Group | Philadelphia | Pennsylvania | 19152 | — |
| Advanced Rheumatology & Arthritis Research Center | Wexford | Pennsylvania | 15090 | — |
| Clinical Research Center of Reading | Wyomissing | Pennsylvania | 19610 | — |
| Emkey Arthritis & Osteoporosis | Wyomissing | Pennsylvania | 19610 | — |
| Low Country Rheumatology, PA | Charleston | South Carolina | 29406 | — |
| Columbia Arthritis Center (Partnership Practice) | Columbia | South Carolina | 29204 | — |
| Piedmont Arthritis Clinic | Greenville | South Carolina | 29601 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Ramesh Gupta - PP | Memphis | Tennessee | 38119 | — |
| Amarillo Center For Clinical Research | Amarillo | Texas | 79124 | — |
| Austin Regional Clinic | Austin | Texas | 78731 | — |
| Lovelace Scientific Resources Inc. | Austin | Texas | 78758 | — |
| Diagnostic Group | Beaumont | Texas | 77701 | — |
| AOCBV | College Station | Texas | 77845 | — |
| Adriana Pop-Moody MD Clinic PA | Corpus Christi | Texas | 78404 | — |
| Arthritis Care & Diagnostic Center | Dallas | Texas | 75231-4406 | — |
| Metroplex Clinical Research | Dallas | Texas | 75231 | — |
| Rheumatic Disease Clin Res Ctr | Houston | Texas | 77004 | — |
| IntraFusion Researh Network | Houston | Texas | 77007 | — |
| Houston Inst. For Clinical Research | Houston | Texas | 77074 | — |
| Accurate Clinical Research | Houston | Texas | 77089 | — |
| Southwest Rheumatology | Mesquite | Texas | 75150 | — |
| Accurate Clinical Management | San Antonio | Texas | 78229 | — |
| NextGen Clinical Research Inc | San Antonio | Texas | 78229 | — |
| Arthiritis & Osteoporosis Centre of South Texas | San Antonio | Texas | 78232 | — |
| Arthritis Clinic Of Central Texas | San Marcos | Texas | 78666 | — |
| Crossroads Clinical Research, LLC | Victoria | Texas | 77901 | — |
| Arthritis & Osteoporosis Clinic | Waco | Texas | 76710 | — |
| South Puget Sound Clinical Research | Olympia | Washington | 98502 | — |
| Arthritis Northwest, Spokane | Spokane | Washington | 99204 | — |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | 98801 | — |
| Mountain State Clinical Research | Clarksburg | West Virginia | 26301 | — |
| Rheumatic Disease Center | Glendale | Wisconsin | 53217 | — |
| Lakeshore Orthopedics | Manitowoc | Wisconsin | 54220 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01855789, 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 Dec 25, 2017 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01855789 live on ClinicalTrials.gov.