An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01254331
First received: December 3, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra]
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: Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis 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:
  • Proportion of patients with American College of Rheumatology Criteria (ACR20) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with American College of Rheumatology Criteria (ACR50) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with American College of Rheumatology Criteria (ACR70) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (Incidence of adverse events) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: February 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Drug: tocilizumab [RoActemra]
tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions

  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 defined as DAS 28>3.2
  • Body weight </=150 kg
  • Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any time prior to study start
  • Inadequate clinical response to a stable dose of a non-biologic DMARD

Exclusion Criteria:

  • Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
  • Rheumatic autoimmune disease other than rheumatoid arthritis (RA)
  • Functional class IV as defined by the ACR classification
  • History or current inflammatory joint disease other than RA
  • Previous treatment with any cell depleting therapy
  • Previous treatment with methotrexate
  • Previous treatment with tocilizumab
  • Previous treatment with any biologic drug that is used in the treatment of RA
  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: NCT01254331

Locations
Tunisia
Sfax, Tunisia, 3000
Sousse, Tunisia, 4000
Tunis, Tunisia, 2046
Tunis, Tunisia, 1007
Tunis, Tunisia, 2010
Tunis, Tunisia, 1008
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: NCT01254331     History of Changes
Other Study ID Numbers: ML22642
Study First Received: December 3, 2010
Last Updated: March 3, 2014
Health Authority: Tunisia: Ministry of Health

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 29, 2014