A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)

Sponsor
Hoffmann-La Roche
Study ID
NCT02534311
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab will be administered at 162 mg SC injection for 48 weeks.

Study Details

The purpose of this clinical trial is to prospectively evaluate RA activity using the assessment of change in DAS28 under local conditions in Slovakia in participants who are treated with subcutaneously administered tocilizumab pursuant to the recommendations of the Ministry of Health of the Slovak Republic in order to better assess the disease activity and impairment of the joint function.

Key Dates

Start date
Oct 13, 2015
Status verified
Feb 2018
Primary completion
Dec 1, 2015
Completion
Dec 1, 2015

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Tocilizumab
    Participants will receive tocilizumab (162 milligrams \[mg\]) SC injection for 48 weeks.

Primary Outcome Measure

Average change from baseline in DAS28 [ Time Frame: up to Week 24 ]

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