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A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis

Thank you

Trial Information

A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy


Inclusion Criteria:



- adult patients at least 18 years of age with moderate to severe active RA for at
least 6 months;

- inadequate response to current anti-rheumatic therapies, including MTX;

- inadequate response or intolerance to treatment with 1 or more anti-TNF therapies
within 1 year of entering study;

- on stable MTX for at least 8 weeks before entering study;

- patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

- major surgery (including joint surgery) within 8 weeks before screening, or planned
major surgery within 6 months after entering study;

- women who are pregnant or breast-feeding.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients with ACR 20 response

Outcome Time Frame:

Week 24

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

WA18062

NCT ID:

NCT00106522

Start Date:

May 2005

Completion Date:

November 2007

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid
  • Signs and Symptoms

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Albany, Georgia  31701
Great Falls, Montana  59405
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Scarborough, Maine  04074
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
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Baltimore, Maryland  21287
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Charlotte, North Carolina  
Eugene, Oregon  
Milwaukee, Wisconsin  
Indianapolis, Indiana  
Charleston, South Carolina  
Tulsa, Oklahoma  
Las Vegas, Nevada  89109
Jackson, Mississippi  
Bismarck, North Dakota  58501
Salt Lake City, Utah  84112
Coeur D'alene, Idaho  83814