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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00106522
Other study ID # WA18062
Secondary ID
Status Completed
Phase Phase 3
First received March 25, 2005
Last updated November 1, 2016
Start date May 2005
Est. completion date November 2007

Study information

Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Recruitment information / eligibility

Status Completed
Enrollment 499
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;

- inadequate response to current anti-rheumatic therapies, including MTX;

- inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;

- on stable MTX for at least 8 weeks before entering study;

- patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

- major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study;

- women who are pregnant or breast-feeding.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Methotrexate
10-25mg weekly
Placebo
iv every 4 weeks
tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
tocilizumab [RoActemra/Actemra]
4mg/kg iv every 4 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Iceland,  Italy,  Mexico,  Netherlands,  Puerto Rico,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with ACR 20 response Week 24 No
Primary AEs, laboratory parameters, vital signs, ECGs. Throughout study No
Secondary Percentage of patients with ACR 50 and ACR 70 responses Week 24 No
Secondary Mean changes in parameters of ACR core set Week 24 No
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