A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00109408 |
Recruitment Status :
Completed
First Posted : April 28, 2005
Last Update Posted : November 2, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: Methotrexate Drug: tocilizumab [RoActemra/Actemra] | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 673 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks |
Active Comparator: 2 |
Drug: Methotrexate
7.5-20mg po weekly |
- Percentage of patients with ACR 20 response [ Time Frame: Week 24 ]
- Percentage of patients with ACR 20 response [ Time Frame: Week 8 ]
- Percentage of patients with ACR 50 and ACR 70 responses [ Time Frame: Week 24 ]
- Mean change in parameters of ACR core set [ Time Frame: Week 24 ]
- AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult patients at least 18 years of age with active RA for at least 3 months;
- patients of reproductive potential must be using reliable methods of contraception.
Exclusion Criteria:
- major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
- treatment with methotrexate (MTX) within 6 months of entering study;
- patients who have stopped previous MTX treatment due to toxicity or lack of response;
- women who are pregnant or breast-feeding.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109408

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00109408 |
Other Study ID Numbers: |
WA17824 |
First Posted: | April 28, 2005 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |