A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis (ROSE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00531817

First received: September 18, 2007

Last updated: August 13, 2012

Last verified: August 2012

History of Changes

Results First Received: July 6, 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 Drug: Placebo Drug: Permitted DMARDs

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
Tocilizumab 8 mg/kg + DMARDs	Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
Placebo + DMARDs	Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.

Participant Flow for 2 periods

Period 1: Randomized

	Tocilizumab 8 mg/kg + DMARDs	Placebo + DMARDs
STARTED	412	207
Received Study Drug in Core Study	409 ^[1]	205 ^[2]
COMPLETED	353	173
NOT COMPLETED	59	34

[1]	3 patients did not receive any study medication. Intent-to-treat population = 409.
[2]	2 patients did not receive any study medication. Intent-to-treat population = 205.

Period 2: Entered Extended Treatment Period

	Tocilizumab 8 mg/kg + DMARDs	Placebo + DMARDs
STARTED	343 ^[1]	170 ^[1]
COMPLETED	206	113
NOT COMPLETED	137	57

[1]	Eligible patients completing core study could participate in extension at investigator’s discretion.

Baseline Characteristics

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Reporting Groups

	Description
Tocilizumab 8 mg/kg + DMARDs	Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
Placebo + DMARDs	Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
Total	Total of all reporting groups

Baseline Measures

	Tocilizumab 8 mg/kg + DMARDs	Placebo + DMARDs	Total
Number of Participants [units: participants]	409	205	614
Age ^[1] [units: years] Mean ± Standard Deviation	55.2 ± 12.06	55.8 ± 12.42	55.5 ± 12.24
Gender ^[1] [units: participants]
Female	325	172	497
Male	84	33	117

[1]	Intent-to-treat population: Tocilizumab 8 mg/kg + DMARDs, n = 409 and Placebo + DMARDs, n = 205

Outcome Measures

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1. Primary:

Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 [ Time Frame: Baseline to Week 24 ]

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2. Secondary:

Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Weeks 4, 8, 12, 16, 20, and 24 [ Time Frame: Baseline to Weeks 4, 8, 12, 16, 20, 24 ]

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3. Secondary:

Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 4, 8, 12, 16, 20, and 24 [ Time Frame: Baseline to Weeks 4, 8, 12, 16, 20, 24 ]

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4. Secondary:

Percentage of Patients With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 4, 8, 12, 16, 20, and 24 [ Time Frame: Baseline to Weeks 4, 8, 12, 16, 20, and 24 ]

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5. Secondary:

Mean Change From Baseline in the Routine Assessment Patient Index Data (RAPID) Score at Weeks 4, 8, 12, 16, 20, and 24 [ Time Frame: Baseline to Weeks 4, 8, 12, 16, 20, and 24 ]

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6. Secondary:

Mean Change From Baseline in 12-Item Short Form Health Survey v2 (SF-12) Scores at Weeks 4, 8, 12, 16, 20, and 24 [ Time Frame: Baseline to Weeks 4, 8, 12, 16, 20, and 24 ]

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7. Secondary:

Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 4, 8, 12, 16, 20, and 24 [ Time Frame: Baseline to Weeks 4, 8, 12, 16, 20, and 24 ]

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8. Secondary:

Mean Change From Baseline in the Medical Outcomes Study (MOS) Sleep Scale Score at Weeks 4, 8, 12, 16, 20, and 24 [ Time Frame: Baseline to Weeks 4, 8, 12, 16, 20, and 24 ]

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9. Secondary:

Mean Change From Baseline in Individual Components of the Routine Assessment Patient Index Data (RAPID) at Each Day During the First 7 Days of Treatment [ Time Frame: Baseline through Day 7 ]

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10. Secondary:

Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Day 7 [ Time Frame: Baseline to Day 7 ]

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11. Secondary:

Mean Change From Baseline in C-reactive Protein (CRP) at Days 3 and 7 [ Time Frame: Baseline to Days 3 and 7 ]

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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:

Yazici Y, Curtis JR, Ince A, Baraf H, Malamet RL, Teng LL, Kavanaugh A. Efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis and a previous inadequate response to disease-modifying antirheumatic drugs: the ROSE study. Ann Rheum Dis. 2012 Feb;71(2):198-205. Epub 2011 Sep 26.

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00531817 History of Changes
Other Study ID Numbers:	ML21136
Study First Received:	September 18, 2007
Results First Received:	July 6, 2010
Last Updated:	August 13, 2012
Health Authority:	United States: Food and Drug Administration

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