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A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00848120
First received: February 19, 2009
Last updated: November 19, 2010
Last verified: November 2010
History of Changes
  Purpose

This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8mg/kg iv every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 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: An Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients with ACR20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with ACR50 and ACR70 responses; change from baseline in DAS28; proportion of patients with DAS28<2.6;QOL scores (HAQ-DI and FACIT) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Time to onset of ACR20/50/70 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: At each visit to week 24 ] [ Designated as safety issue: No ]

Enrollment: 29
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 24 weeks

  Eligibility

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

Inclusion Criteria:

  • adult patients,>=18 years of age;
  • rheumatoid arthritis diagnosed >8 weeks and <4 years prior to baseline;
  • naive to, or not responding well to, methotrexate;
  • swollen joint count >=8 (66 joint count) and tender joint count>=8 (68 joint count) at screening and baseline.

Exclusion Criteria:

  • rheumatic autoimmune disease other than rheumatoid arthritis;
  • patients with functional class IV rheumatoid arthritis;
  • history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848120

Locations
Philippines
Manila, Philippines, 1000
Muntinlupa, Philippines, 1770
San Fernando, Philippines, 2000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00848120     History of Changes
Other Study ID Numbers: ML22074
Study First Received: February 19, 2009
Last Updated: November 19, 2010
Health Authority: Philippines: Department of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013