Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00538902

First received: October 1, 2007

Last updated: April 7, 2011

Last verified: April 2011

History of Changes

Results First Received: November 23, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Interventions:	Biological: Placebo Biological: Adalimumab 80 mg Biological: Adalimumab 40 mg

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	Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
Adalimumab 40 mg	Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 24 weeks.
Adalimumab 80 mg	Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.

Participant Flow for 2 periods

Period 1: DB Wk 0 Through 12 (Primary D/C Reasons)

	Placebo	Adalimumab 40 mg	Adalimumab 80 mg
STARTED	60	121	121
COMPLETED	59	119	116
NOT COMPLETED	1	2	5
Adverse Event	1	2	3
Withdrawal by Subject	0	0	1
Lost to Follow-up	0	0	1
Various	0	0	0

Period 2: OL Wk 24 to End (Primary D/C Reasons)

	Placebo	Adalimumab 40 mg	Adalimumab 80 mg
STARTED	59	119	116
COMPLETED	23	55	52
NOT COMPLETED	36	64	64
Adverse Event	2	10	11
Withdrawal by Subject	15	19	25
Lost to Follow-up	1	10	6
Various	18	25	22

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
Adalimumab 40 mg	Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
Adalimumab 80 mg	Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Adalimumab 40 mg	Adalimumab 80 mg	Total
Number of Participants [units: participants]	60	121	121	302
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	58	115	111	284
>=65 years	2	6	10	18
Gender [units: participants]
Female	49	104	101	254
Male	11	17	20	48
Region of Enrollment [units: participants]
China	60	121	121	302

Outcome Measures

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1. Primary:

Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period [ Time Frame: Week 12 ]

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2. Secondary:

Number of Participants Achieving American College of Rheumatology (ACR)50/70 at Week 12 of the Double-Blind Period [ Time Frame: Week 12 ]

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3. Secondary:

Number of Participants Achieving American College of Rheumatology (ACR)20 Response Through Week 92 of Open-Label Period [ Time Frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

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4. Secondary:

Number of Participants Achieving American College of Rheumatology (ACR)50 Response Through Week 92 of Open-Label Period [ Time Frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

Show Outcome Measure 4

5. Secondary:

Number of Participants Achieving American College of Rheumatology (ACR)70 Response Through Week 92 of Open-Label Period [ Time Frame: Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

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6. Secondary:

Mean Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 12 of the Double-Blind Period [ Time Frame: Baseline, Week 12 ]

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7. Secondary:

Mean Change in Tender Joint Count (TJC) Through Week 92 of the Open-Label Period [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

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8. Secondary:

Mean Change in Swollen Joint Count (SJC) Through Week 92 of the Open-Label Period [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

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9. Secondary:

Mean Change in Visual Analog Scale (VAS) Score at Week 12 of the Double-Blind Period [ Time Frame: Baseline, Week 12 ]

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10. Secondary:

Mean Change in Physician's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

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11. Secondary:

Mean Change in Patient's Assessment of Pain (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

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12. Secondary:

Mean Change in Patient's Global Assessment of Disease Activity (Visual Analog Scale [VAS]) Through Week 92 of the Open-Label Period [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

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13. Secondary:

Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Scores From Baseline to Week 12 of the Double-Blind Period [ Time Frame: Baseline, Week 12 ]

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14. Secondary:

Mean Change in the Disability Index of the Health Assessment Questionnaire (HAQ) Through Week 92 of the Open-Label Period [ Time Frame: Baseline, Week 0, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

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15. Secondary:

Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 12 of the Double-Blind Period [ Time Frame: Baseline, Week 12 ]

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16. Secondary:

Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 92 of the Open-Label Period [ Time Frame: Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

Show Outcome Measure 16

17. Secondary:

Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 92 of the Open-Label Period [ Time Frame: Baseline, Week 0, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 92 ]

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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: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

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: Global Medical Services
Organization: Abbott
phone: 800-633-9110

No publications provided

Responsible Party:	Laura Redden MD, PhD, Project Director, Abbott
ClinicalTrials.gov Identifier:	NCT00538902 History of Changes
Other Study ID Numbers:	M04-705
Study First Received:	October 1, 2007
Results First Received:	November 23, 2009
Last Updated:	April 7, 2011
Health Authority:	China: Food and Drug Administration

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