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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00106548

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: tocilizumab Drug: Placebo Drug: Methotrexate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

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 ACR 50/70 responses; change from baseline in ACR core set components. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	623
Study Completion Date:	October 2007

Arms	Assigned Interventions
1: Experimental	Drug: tocilizumab 4mg/kg iv / month Drug: Methotrexate 10-25mg/week
2: Experimental	Drug: tocilizumab 8mg/kg iv / month Drug: Methotrexate 10-25mg/week
3: Placebo Comparator	Drug: Placebo iv / month Drug: Methotrexate 10-25mg/week

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106548

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Locations

Argentina

BUENOS AIRES, Argentina, C1015ABO

BUENOS AIRES, Argentina, C1428CQG

BUENOS AIRES, Argentina, 1405
Australia

SHENTON PARK, Australia, 6008

MAROOCHYDORE, Australia, 4558

ADELAIDE, Australia, 5041

DOUGLAS, Australia, 4184
Austria

WIEN, Austria, 1090

WIEN, Austria, 1130

WIEN, Austria, 1160

WIEN, Austria, 1100
Brazil

PORTO ALEGRE, Brazil, 91350-200

SAO PAULO, Brazil, 05651-901
Bulgaria

SOFIA, Bulgaria, 1784

SOFIA, Bulgaria, 1606

VARNA, Bulgaria, 9010
Canada, Alberta

CALGARY, Alberta, Canada, T2N 4N1
Canada, British Columbia

VICTORIA, British Columbia, Canada, V8V 3P9

VANCOUVER, British Columbia, Canada, V5Z 1L7
Canada, Manitoba

WINNIPEG, Manitoba, Canada, R3A 1M3
Canada, Newfoundland and Labrador

ST JOHN'S, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Ontario

TORONTO, Ontario, Canada, M4N 3M5

NEWMARKET, Ontario, Canada, L3Y 3R7

OTTAWA, Ontario, Canada, K1H 1A2

BURLINGTON, Ontario, Canada, L7M 4Y1
Canada, Quebec

SAINTE-FOY, Quebec, Canada, G1W 4R4

MONTREAL, Quebec, Canada, H2L 1S6

MONTREAL, Quebec, Canada, H1T 4B3
China

HONG KONG, China, 852

HONG KONG, China
France

PARIS, France, 75014

BESANCON, France, 25030

PARIS, France, 75010

LE MANS, France, 72000

CRETEIL, France, 94010

PARIS, France, 75012

MONTPELLIER, France, 34295
Germany

BERLIN, Germany, 14059

BADEN-BADEN, Germany, 76530

HEIDELBERG, Germany, 69120

BAD BRAMSTEDT, Germany, 24576

BAD NAUHEIM, Germany, 61231

KÖLN, Germany, 50924

ERLANGEN, Germany, 91056

TÜBINGEN, Germany, 72076
Hungary

Pécs, Hungary, 7632

BUDAPEST, Hungary, 1023

DEBRECEN, Hungary, 4004
Israel

PETACH TIKVA, Israel, 49100

HAIFA, Israel, 31096

HAIFA, Israel, 31048

JERUSALEM, Israel, 91120

BEER SHEVA, Israel, 84101

TEL AVIV, Israel, 64239
Italy

SIENA, Italy, 53100

GAZZI, Italy, 98125

PALERMO, Italy, 90127

FERRARA, Italy, 44100

UDINE, Italy, 33100
Mexico

GUADALAJARA, Mexico, 44620

MEXICO CITY, Mexico, 07760

CHIHUAHUA, Mexico, 31000

MEXICO CITY, Mexico, 14080

GUADALAJARA, Mexico, 44690

SAN LUIS POTOSI, Mexico, 78240
Singapore

SINGAPORE, Singapore, 258499

SINGAPORE, Singapore, 119074
Slovakia

PIESTANY, Slovakia, 921 01
Switzerland

LAUSANNE, Switzerland, 1011

ST GALLEN, Switzerland, 9007

BERN, Switzerland, 3010
Thailand

CHIANG MAI, Thailand, 50200

BANGKOK, Thailand, 10400

BANGKOK, Thailand, 10700

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, Woodworth T, Alten R; OPTION Investigators. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008 Mar 22;371(9617):987-97.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	WA17822
Study First Received:	March 25, 2005
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00106548 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Signs and Symptoms
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases

Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 30, 2009