A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00109408
First received: April 27, 2005
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo p

o weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. 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]
Drug: Methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients with ACR 20 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with ACR 20 response [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Percentage of patients with ACR 50 and ACR 70 responses [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Mean change in parameters of ACR core set [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 673
Study Start Date: July 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
Active Comparator: 2 Drug: Methotrexate
7.5-20mg po weekly

  Eligibility

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

Inclusion Criteria:

  • adult patients at least 18 years of age with active RA for at least 3 months;
  • patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

  • major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
  • treatment with methotrexate (MTX) within 6 months of entering study;
  • patients who have stopped previous MTX treatment due to toxicity or lack of response;
  • women who are pregnant or breast-feeding.
  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: NCT00109408

  Show 147 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00109408     History of Changes
Other Study ID Numbers: WA17824
Study First Received: April 27, 2005
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

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 August 21, 2014