A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis

Sponsor
Hoffmann-La Roche
Study ID
NCT01987479
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Non-Biologic DMARDs — DRUG
    Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study and is at the investigator's discretion.
  • Tocilizumab — DRUG
    Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 24 weeks.
  • Methotrexate — DRUG
    Methotrexate will be administered per investigator's discretion.

Study Details

This multi-center, open-label single arm Phase IIIb study will evaluate the safety and efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) in participants with rheumatoid arthritis (RA) with an inadequate response to non-biologic DMARDs.

Key Dates

Start date
Jan 30, 2014
Status verified
May 2017
Primary completion
May 26, 2016
Completion
May 26, 2016

Study Design

Enrollment
150 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab Alone or in Combination with Methotrexate or DMARD
    Participants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.

Primary Outcome Measure

Percentage of Participants With Adverse Events [ Time Frame: Baseline up to Week 32 ]

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