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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00750880
First received: September 10, 2008
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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)

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00750880

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov 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
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014