A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00810277
First received: December 16, 2008
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This single arm study will assess the safety and efficacy of tocilizumab in pati ents with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of t ocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherap y or in combination with their current non-biologic DMARDs.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individual s.


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 Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Adverse events;serious adverse events [ Time Frame: Throughout study;assessments made at every 4 week visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DAS28;ACR20,50 and 70 responses;CRP and ESR [ Time Frame: Throughout study;assessments made at every 4 week visit ] [ Designated as safety issue: No ]
  • Premature withdrawals; ALT and AST elevations; no. of patients with lipid elevations; neutrophil count [ Time Frame: Throughout study;assessments made at every 4 week visit ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: November 2008
Study Completion Date: May 2010
Primary Completion Date: May 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;
  • moderate to severe rheumatoid arthritis;
  • inadequate response to current non-biologic DMARDs;
  • <=150kg body weight.

Exclusion Criteria:

  • rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
  • previous treatment with other biologics.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810277

Locations
Finland
Helsinki, Finland, 00130
Hyvinkää, Finland, 05800
Hämeenlinna, Finland, 13530
Riihimäki, Finland, 11101
Tampere, Finland, 33100
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: NCT00810277     History of Changes
Other Study ID Numbers: ML22012, 2008-004126-16
Study First Received: December 16, 2008
Last Updated: October 6, 2014
Health Authority: Finland: Finnish Medicines Agency

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

ClinicalTrials.gov processed this record on October 22, 2014