| March 25, 2005 |
| May 13, 2009 |
| |
| |
| Percentage of patients with ACR 20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ] |
| Efficacy: Proportion of patients with an ACR20 response at Week 24 |
| Complete list of historical versions of study NCT00106548 on ClinicalTrials.gov Archive Site |
- Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|
| Efficacy: Proportion of patients with ACR50 and ACR70 responses; mean changes from baseline in individual parameters of ACR core set at 24 weeks; AUC of the ACR(n) Safety: AEs, laboratory results, vital signs |
| |
| A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis |
| A Randomized, Double-Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis |
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Rheumatoid Arthritis |
- Drug: tocilizumab
- Drug: Placebo
- Drug: Methotrexate
|
| |
| Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, Woodworth T, Alten R; OPTION Investigators. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008 Mar 22;371(9617):987-97. |
| |
| Completed |
| 623 |
| October 2007 |
|
Inclusion Criteria:
- adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
- inadequate response to a stable dose of MTX;
- 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 surgery within 6 months after entering study;
- prior treatment failure with an anti-tumor necrosis factor agent;
- women who are pregnant or breast-feeding.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, France, Germany, Hungary, Israel, Italy, Mexico, Singapore, Slovakia, Switzerland, Thailand |
| |
| NCT00106548 |
| Clinical Trials, Study Director, Hoffmann-La Roche |
| WA17822 |
| Hoffmann-La Roche |
|
| Study Director: |
Clinical Trials |
Hoffmann-La Roche, +1 973 235 5000 |
|
|
| Hoffmann-La Roche |
| May 2009 |
