A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis

Hoffmann-La Roche30 enrolled

Overview

This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis. Patients who successfully completed studies WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will be allowed DMARDs according to the treatment they received in the previous studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 104 weeks.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

tocilizumab [RoActemra/Actemra]DRUG

8 mg/kg intravenously every 4 weeks in combination with allowed DMARDs

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/=18 years of age * Moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study * Patients successfully completed studies WA17823 and WA18696 in South Africa * Body weight \<150 kg Exclusion Criteria: * Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug in studies WA17823 and WA18696 * Previous treatment with any cell depleting therapies * Treatment with intravenous gamma globulin, plasmapheresis or Prosorba(TM) column since the last administration of study drug in studies WA17823 and WA18696

Locations (4)

Unnamed facility

Cape Town, South Africa

Unnamed facility

Cape Town, South Africa

Unnamed facility

Cape Town, South Africa

Unnamed facility

Diepkloof, South Africa

Outcomes

Primary Outcomes

Safety (incidence of adverse events)

Time frame: 104 weeks

Safety (laboratory assessments e.g. hematology)

Time frame: 104 weeks

Secondary Outcomes

Efficacy: Change in Disease Activity Score (DAS28)

Time frame: 104 weeks

Data from ClinicalTrials.gov

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