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A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00773461
First received: October 15, 2008
Last updated: May 18, 2011
Last verified: May 2011
History of Changes
  Purpose

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: tocilizumab [RoActemra/Actemra]
Drug: Placebo
 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 Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD Therapy

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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in individual parameters of ACR core set [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in a) HAQ-DI, b) FACIT fatigue score, c) rheumatoid factor, d) hemoglobin [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Time to onset of ACR20, 50 and 70 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Proportion of patients achieving a) DAS28 <3.2 and b) DAS28 <2.6 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 209
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 24 weeks
Placebo Comparator: 2 Drug: Placebo
iv every 4 weeks for 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-70 years of age;
  • rheumatoid arthritis for >= 6 months;
  • receiving permitted DMARDs, at a stable dose, for >= 8 weeks prior to baseline;
  • current inadequate clinical response to DMARDs.

Exclusion Criteria:

  • major surgery, including joint surgery, within 8 weeks before entering study, or planned major surgery within 6 months following randomization;
  • rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
  • unsuccessful treatment with an anti-TNF agent;
  • previous treatment with tocilizumab.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773461

Locations
China
Beijing, China, 100044
Beijing, China, 100032
Beijing, China, 100853
Guangzhou, China, 510630
Harbin, China, 150001
Jinan, China, 250012
Shanghai, China, 200001
Shanghai, China, 200433
Xi'an, China, 710032
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: NCT00773461     History of Changes
Other Study ID Numbers: ML21753
Study First Received: October 15, 2008
Last Updated: May 18, 2011
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013