An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: September 10, 2008
Last updated: October 28, 2013
Last verified: October 2013

This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International Multi-Center 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 or Anti-TNF Therapy.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of adverse events and serious adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment discontinuations overall and by TNF antagonist use; incidence of LFT and lipid abnormalities; disease activity measured by DAS28; clinically meaningful improvement in DAS28 score. [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Low DAS28 (<3.2) and time to low DAS28; ACR20, ACR50, ACR70 and ACR90 response rates; change from baseline in ACR core set; quality of life assessment. [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
  • Disease activity as measured by DAS28 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Standard AE reporting; lipid elevations, major cardiac events, strokes, infections, increased neutrophils and transaminases. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 1697
Study Start Date: September 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv (60 minute infusion)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male and non-pregnant or nursing female patients >=18 years of age;
  • body weight <=150kg;
  • moderate to severe active RA (DAS28 >=3.2) of >=6 months duration;
  • on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start of treatment;
  • inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
  • if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.

Exclusion Criteria:

  • major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
  • rheumatic autoimmune disease other than RA;
  • prior history of, or current inflammatory joint disease other than RA;
  • functional class IV as defined by the ACR Classification of Functional Status in RA.
  Contacts and Locations
Please refer to this study by its identifier: NCT00750880

  Show 282 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT00750880     History of Changes
Other Study ID Numbers: MA21573, 2008-000587-17
Study First Received: September 10, 2008
Last Updated: October 28, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014