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OpenTrials
Completed

NCT Number: NCT01214733

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cape Town, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug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

Treatment and study plan

tocilizumab [RoActemra/Actemra]

Drug

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

Primary outcomes

  1. Safety (incidence of adverse events)

    Time frame: 104 weeks

  2. Safety (laboratory assessments e.g. hematology)

    Time frame: 104 weeks

Secondary outcomes

  1. Efficacy: Change in Disease Activity Score (DAS28)

    Time frame: 104 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2010
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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