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Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Rheumatoid Arthritis

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Trial Information

Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD


Inclusion Criteria:



- Adult patients, >/=18 years of age

- Moderate to severe active rheumatoid arthritis (DAS28>/=3.2) of >/=6 months duration

- Body weight
- Patients are on one or more non-biologic DMARDs at a stable dose for a period >/=8
weeks prior to study treatment

- Patients with inadequate clinical response to a stable dose of non-biologic DMARD

Exclusion Criteria:

- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization

- Rheumatic autoimmune disease other than rheumatoid arthritis, including systemic
lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or
significant systemic involvement secondary to rheumatoid arthritis

- History of or current inflammatory joint disease other than rheumatoid arthritis

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety (incidence of adverse events)

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Turkey: Ministry of Health

Study ID:

ML25095

NCT ID:

NCT01245439

Start Date:

September 2011

Completion Date:

July 2014

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

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