Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00445770

First received: March 8, 2007

Last updated: August 10, 2011

Last verified: August 2011

History of Changes

Results First Received: July 12, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	Arthritis, Rheumatoid
Interventions:	Drug: Etanercept 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
Methotrexate	Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
Etanercept 10 mg	Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
Etanercept 25 mg	Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks

Participant Flow: Overall Study

	Methotrexate	Etanercept 10 mg	Etanercept 25 mg
STARTED	176	192	182
COMPLETED	123	157	151
NOT COMPLETED	53	35	31
Adverse Event	9	15	19
Lack of Efficacy	38	13	6
Lost to Follow-up	0	2	0
Not specified	6	5	6

Baseline Characteristics

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Reporting Groups

	Description
Methotrexate	Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
Etanercept 10 mg	Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
Etanercept 25 mg	Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
Total	Total of all reporting groups

Baseline Measures

	Methotrexate	Etanercept 10 mg	Etanercept 25 mg	Total
Number of Participants [units: participants]	176	192	182	550
Age [units: years] Mean ± Standard Deviation	50.40 ± 11.91	51.46 ± 12.21	51.81 ± 11.07	51.24 ± 11.74
Gender [units: participants]
Female	140	154	145	439
Male	36	38	37	111
modified Total Sharp Score (mTSS) ^[1] [units: scores on a scale] Mean ± Standard Deviation	43.01 ± 46.78	45.17 ± 38.75	41.98 ± 41.51	43.42 ± 42.28
Erosion Score ^[2] [units: scores on a scale] Mean ± Standard Deviation	25.09 ± 26.30	26.66 ± 22.1	25.23 ± 23.88	25.69 ± 24.05
Joint Space Narrowing (JSN) Score ^[3] [units: scores on a scale] Mean ± Standard Deviation	17.92 ± 21.93	18.50 ± 19.14	16.75 ± 19.11	17.73 ± 20.03

[1]	mTSS=sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). Total mTSS scores possible ranged from 0 (normal) to 448 (worst possible total score).
[2]	Joint erosion score: erosion severity in 44 joints (16 per hand and 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, total erosion score possible ranged from 0 (no erosion) to 280 (worst possible total score).
[3]	JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Total JSN scores possible ranged from 0 (no/normal JSN) to 168 (worst possible total score).

Outcome Measures

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1. Primary:

Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 [ Time Frame: Week 52 ]

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2. Secondary:

Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 [ Time Frame: Week 24 ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in Erosion Score at Weeks 24 and 52 [ Time Frame: Baseline, Week 24, and Week 52 ]

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4. Secondary:

Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52 [ Time Frame: Baseline, Week 24, and Week 52 ]

Show Outcome Measure 4

5. Secondary:

Percentage of Participants With no Progression of Joint Destruction at Week 52 [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 6

7. Secondary:

Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 7

8. Secondary:

Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 8

9. Secondary:

Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 9

10. Secondary:

Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 10

11. Secondary:

Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 11

12. Secondary:

Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 12

13. Secondary:

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 13

14. Secondary:

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

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15. Secondary:

Percentage of Participants With an ACR50 Response [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

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16. Secondary:

Percentage of Participants With an ACR70 Response [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 16

17. Secondary:

Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 17

18. Secondary:

Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 18

19. Secondary:

Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 19

20. Secondary:

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 [ Time Frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 ]

Show Outcome Measure 20

21. Other Pre-specified:

Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses [ Time Frame: Weeks 12, 24, 52 ]

Show Outcome Measure 21

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: Wyeth has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
Total Sharp Score and modified total Sharp Score were used interchangeably in the protocol and meant the same thing. In the statistical analysis plan and study results, mTSS was used consistently.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00445770 History of Changes
Other Study ID Numbers:	0881A1-315, B1801002
Study First Received:	March 8, 2007
Results First Received:	July 12, 2011
Last Updated:	August 10, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

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