A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01010503
First received: November 9, 2009
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Phase 4

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: Evaluation of Adherence and Persistence to Tocilizumab in Combination With Methotrexate or Tocilizumab Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis in Local Environment.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Adherence and persistence to tocilizumab therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability: SAEs, AEs [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: tocilizumab [RoActemra/Actemra]
tocilizumab 8 mg/kg intravenous infusion once in 4 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 active rheumatoid arthritis
  • inadequate response, or intolerance to previous therapy with one or more traditional DMARDs
  • DAS >3.6
  • pneumology examination (including chest x-ray and quantiferon)

Exclusion Criteria:

  • < 18 years of age
  • active infection
  • active tuberculosis
  • uncontrolled hyperlipoproteinaemia
  • demyelinating disorders
  • concomitant anti-TNF drugs
  • history of intestinal ulceration and diverticulitis
  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: NCT01010503

Locations
Slovakia
Piestany, Slovakia, 921 12
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: NCT01010503     History of Changes
Other Study ID Numbers: ML22508, 2009-011520-53
Study First Received: November 9, 2009
Last Updated: June 15, 2011
Health Authority: Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014