A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00106535

First received: March 25, 2005

Last updated: December 18, 2012

Last verified: December 2012

History of Changes

Results First Received: February 9, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Interventions:	Drug: tocilizumab [RoActemra/Actemra] Drug: Placebo Drug: Methotrexate

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo + Methotrexate	Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
Tocilizumab 4 mg/kg + Methotrexate	Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly
Tocilizumab 8 mg/kg + Methotrexate	Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly

Participant Flow: Overall Study

	Placebo + Methotrexate	Tocilizumab 4 mg/kg + Methotrexate	Tocilizumab 8 mg/kg + Methotrexate
STARTED	394 ^[1]	401 ^[2]	401 ^[3]
COMPLETED	356	373	366
NOT COMPLETED	38	28	35

[1]	One patient who was randomized but withdrew before first infusion is not included
[2]	Two patients who were randomized but withdrew before first infusion are not included
[3]	Three patients who were randomized but withdrew before first infusion are not included

Baseline Characteristics

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Reporting Groups

	Description
Placebo + Methotrexate	Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
Tocilizumab 4 mg/kg + Methotrexate	Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly
Tocilizumab 8 mg/kg + Methotrexate	Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly
Total	Total of all reporting groups

Baseline Measures

	Placebo + Methotrexate	Tocilizumab 4 mg/kg + Methotrexate	Tocilizumab 8 mg/kg + Methotrexate	Total
Number of Participants [units: participants]	393	399	398	1190
Age [units: years] Mean ± Standard Deviation	51.3 ± 12.41	51.4 ± 12.59	53.4 ± 11.72	52.0 ± 12.24
Gender [units: participants]
Female	328	336	325	989
Male	65	63	73	201

Outcome Measures

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1. Primary:

Percentage of Patients With American College of Rheumatology-ACR20 Response [ Time Frame: Week 24 ]

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2. Secondary:

Percentage of Patients With ACR50 Response [ Time Frame: Week 24 ]

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3. Secondary:

Percentage of Patients With ACR70 Response [ Time Frame: Week 24 ]

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4. Secondary:

Swollen Joint Count (66 Joint Count): Mean Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]

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5. Secondary:

Tender Joint Count (68 Joint Count): Mean Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]

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6. Secondary:

Patient's Global Visual Analog Scale (VAS): Mean Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]

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7. Secondary:

Physician's Global VAS: Mean Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]

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8. Secondary:

Patient's Pain VAS: Mean Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]

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9. Secondary:

C-Reactive Protein (CRP): Mean Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]

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10. Secondary:

Erythrocyte Sedimentation Rate: Mean Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]

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11. Secondary:

Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Week 24 [ Time Frame: Baseline and Week 24 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590

No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Kremer JM, Blanco R, Brzosko M, Burgos-Vargas R, Halland AM, Vernon E, Ambs P, Fleischmann R. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate: results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of structural joint damage at one year. Arthritis Rheum. 2011 Mar;63(3):609-21.

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00106535 History of Changes
Other Study ID Numbers:	WA17823
Study First Received:	March 25, 2005
Results First Received:	February 9, 2010
Last Updated:	December 18, 2012
Health Authority:	United States: Food and Drug Administration

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