A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106548
Recruitment Status : Completed
First Posted : March 28, 2005
Last Update Posted : June 11, 2010
Information provided by:
Hoffmann-La Roche

Brief Summary:
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: tocilizumab [RoActemra/Actemra] Drug: Placebo Drug: Methotrexate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 623 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
4mg/kg iv / month
Drug: Methotrexate
Experimental: 2 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv / month
Drug: Methotrexate
Placebo Comparator: 3 Drug: Placebo
iv / month
Drug: Methotrexate

Primary Outcome Measures :
  1. Percentage of patients with ACR 20 response [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components. [ Time Frame: Week 24 ]
  2. AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
  • inadequate response to a stable dose of MTX;
  • 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 surgery within 6 months after entering study;
  • prior treatment failure with an anti-tumor necrosis factor agent;
  • women who are pregnant or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00106548

  Hide Study Locations
Buenos Aires, Argentina, 1405
Buenos Aires, Argentina, C1015ABO
Buenos Aires, Argentina, C1428CQG
Adelaide, Australia, 5041
Douglas, Australia, 4184
Maroochydore, Australia, 4558
Shenton Park, Australia, 6008
Wien, Austria, 1090
Wien, Austria, 1100
Wien, Austria, 1130
Wien, Austria, 1160
Porto Alegre, Brazil, 91350-200
Sao Paulo, Brazil, 05651-901
Sofia, Bulgaria, 1606
Sofia, Bulgaria, 1784
Varna, Bulgaria, 9010
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1L7
Victoria, British Columbia, Canada, V8V 3P9
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Newfoundland and Labrador
St John's, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Ontario
Burlington, Ontario, Canada, L7M 4Y1
Newmarket, Ontario, Canada, L3Y 3R7
Ottawa, Ontario, Canada, K1H 1A2
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, H1T 4B3
Montreal, Quebec, Canada, H2L 1S6
Sainte-foy, Quebec, Canada, G1W 4R4
Hong Kong, China, 852
Hong Kong, China
Besancon, France, 25030
Creteil, France, 94010
Le Mans, France, 72000
Montpellier, France, 34295
Paris, France, 75010
Paris, France, 75012
Paris, France, 75014
Bad Bramstedt, Germany, 24576
Bad Nauheim, Germany, 61231
Baden-baden, Germany, 76530
Berlin, Germany, 14059
Erlangen, Germany, 91056
Heidelberg, Germany, 69120
Köln, Germany, 50924
Tübingen, Germany, 72076
Budapest, Hungary, 1023
Debrecen, Hungary, 4004
Pécs, Hungary, 7632
Beer Sheva, Israel, 84101
Haifa, Israel, 31048
Haifa, Israel, 31096
Jerusalem, Israel, 91120
Petach Tikva, Israel, 49100
Tel Aviv, Israel, 64239
Ferrara, Italy, 44100
Gazzi, Italy, 98125
Palermo, Italy, 90127
Siena, Italy, 53100
Udine, Italy, 33100
Chihuahua, Mexico, 31000
Guadalajara, Mexico, 44620
Guadalajara, Mexico, 44690
Mexico City, Mexico, 07760
Mexico City, Mexico, 14080
San Luis Potosi, Mexico, 78240
Singapore, Singapore, 119074
Singapore, Singapore, 258499
Piestany, Slovakia, 921 01
Bern, Switzerland, 3010
Lausanne, Switzerland, 1011
St Gallen, Switzerland, 9007
Bangkok, Thailand, 10400
Bangkok, Thailand, 10700
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche Identifier: NCT00106548     History of Changes
Other Study ID Numbers: WA17822
First Posted: March 28, 2005    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010

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