A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT01007435. 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 Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.
Study identification
- NCT ID
- NCT01007435
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,162 participants
Conditions and interventions
Conditions
Interventions
- Tocilizumab Drug
- Placebo to tocilizumab Drug
- Methotrexate Drug
- Placebo to methotrexate 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
- Oct 31, 2009 (Actual)
- Primary completion
- May 31, 2012 (Actual)
- Completion
- Jan 28, 2014 (Actual)
- Last update posted
- Jul 26, 2017
2009 – 2014
United States locations
- U.S. sites
- 61
- U.S. states
- 28
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group; Llc, Central | Anniston | Alabama | 36207 | — |
| Rheumatology Associates of North Alabama | Huntsville | Alabama | 35801 | — |
| Clnical & Translational Reseach Center for Alabama, PC | Tuscaloosa | Alabama | 35406 | — |
| Arthrocare, Arthritis Care and Research, P.C. | Mesa | Arizona | 85208 | — |
| Sun Valley Arthritis Center | Peoria | Arizona | 85381 | — |
| Talbert Medical Group | Huntington Beach | California | 92646 | — |
| Uni of California - San Diego; Division of Rheumatology | La Jolla | California | 92037 | — |
| Valerius Medical Group & Research Ctr of Greater Long Beach | Los Alamitos | California | 90720 | — |
| Sharp Rees-Stealy Medical Group | San Diego | California | 92101 | — |
| San Diego Arthritis Med Clnc | San Diego | California | 92108 | — |
| Denver Arthritis Clinic | Denver | Colorado | 80230-7127 | — |
| Joao Nascimento | Bridgeport | Connecticut | 06606 | — |
| New England Research Associates | Trumbull | Connecticut | 06611 | — |
| Arthritis/Osteoporosis Treatment Center | Orange Park | Florida | 32073 | — |
| Arthritis Center Palm Harbor | Palm Harbor | Florida | 34684 | — |
| Arthritis Rsrch of Florida, Inc. | Palm Harbor | Florida | 34684 | — |
| Burnette & Silverfield, MDS | Tampa | Florida | 33614 | — |
| Quad City Rheumatology, Sc | Moline | Illinois | 61265 | — |
| Illinois Bone & Joint Inst. | Morton Grove | Illinois | 60053 | — |
| Springfield Clinic | Springfield | Illinois | 62703 | — |
| Deerbrook Medical Associates | Vernon Hills | Illinois | 60061 | — |
| Physician'S Clinic of Iowa | Cedar Rapids | Iowa | 52401 | — |
| Via Christi Clinic, PA | Wichita | Kansas | 67208 | — |
| Baton Rouge Clinic, Amc | Baton Rouge | Louisiana | 70808 | — |
| Osteoporosis & Clinical Trials Center | Cumberland | Maryland | 21502 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01605 | — |
| Borgess Rheumatology | Kalamazoo | Michigan | 49009 | — |
| Fiechtner Research Inc | Lansing | Michigan | 48910 | — |
| Harbor Arthritis Center | Petoskey | Michigan | 49770 | — |
| Park Nicollet Inst. ; Rtrc | Minneapolis | Minnesota | 55416 | — |
| Jackson Arthritis Clinic | Flowood | Mississippi | 39232 | — |
| North Mississippi Medical Ctr; Internal Medicine Associates | Tupelo | Mississippi | 38802 | — |
| Depaul Medical Group-SSM Healthcare | Florissant | Missouri | 63031 | — |
| Dartmouth-Hitchcock Medical Center, Rheumatology 5C | Lebanon | New Hampshire | 03756 | — |
| NJP Clinical Research | Clifton | New Jersey | 07012 | — |
| Mark Fisher Md, Facr, Llc | Haddon Heights | New Jersey | 08035 | — |
| Albuquerque Center For Rheumatology | Albuquerque | New Mexico | 87102 | — |
| Arthritis and Osteoporosis Associates of New Mexico | Las Cruces | New Mexico | 88011 | — |
| Arthritis Health Associates; Clinical Research | Syracuse | New York | 13210 | — |
| Asheville Arthritis & Osteoporosis Center, PA | Asheville | North Carolina | 28803 | — |
| Durham Rheumatology | Durham | North Carolina | 27704 | — |
| Ohio State University; Dept of Immunology | Columbus | Ohio | 43210 | — |
| Southwest Rheumatology & Research Group, LLC | Middleburg Heights | Ohio | 44130 | — |
| Health Research of Oklahoma, Llc | Oklahoma City | Oklahoma | 73103 | — |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | — |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | — |
| East Penn Rheumatology Associates, Pc | Bethlehem | Pennsylvania | 18015 | — |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Clinical Research Center of Reading | Wyomissing | Pennsylvania | 19610 | — |
| Piedmont Arthritis Clinic | Greenville | South Carolina | 29601 | — |
| Amarillo Center For Clinical Research | Amarillo | Texas | 79124 | — |
| Accurate Clinical Research | Houston | Texas | 77034 | — |
| Houston Inst. For Clinical Research | Houston | Texas | 77074 | — |
| Arthritis & Osteoporosis Associates, LLP | Lubbock | Texas | 79424 | — |
| Texas Arthritis Research Center; Center for Arthritis & Rheumatic Diseases | San Antonio | Texas | 78217 | — |
| Texas Research Center | Sugar Land | Texas | 77479 | — |
| Arthritis & Osteoporosis Clinic | Waco | Texas | 76710 | — |
| Arthritis Northwest, Spokane | Spokane | Washington | 99204 | — |
| Tacoma Center For Arthritis Research | Tacoma | Washington | 98405 | — |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | 98801 | — |
| Rheumatic Disease Center | Glendale | Wisconsin | 53217 | — |
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 175 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01007435, 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 26, 2017 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01007435 live on ClinicalTrials.gov.